Prostate Cancer

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Phase I/II 225Ac-J591 Plus 177Lu-PSMA-I&T for Progressive Metastatic Castration Resistant Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04886986

Sponsor: Weill Medical College of Cornell University

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 99 Years
  • Gender: Male

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of prostate
  • Documented progressive metastatic CRPC based on Prostate Cancer Working Group 3 (PCWG3) criteria, which includes at least one of the following criteria: PSA progression, Objective radiographic progression in soft tissue, New bone lesions
  • ECOG performance status of 0-2
  • Have serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH/GnRH analogue (agonist/antagonist) if they have not undergone bilateral orchiectomy
  • Have previously been treated with at least one of the following: Androgen receptor signaling inhibitor (such as enzalutamide), CYP 17 inhibitor (such as abiraterone acetate)
  • Have previously received taxane chemotherapy, been determined to be ineligible for taxane chemotherapy by their physician or refused taxane chemotherapy
  • Age > 18 years
  • Patients must have normal organ and marrow function as defined below: Absolute neutrophil count: >2,000 cells/mm3, Hemoglobin: ≥9 g/dL, Platelet count: >150,000 x 109/uL, Serum creatinine: <1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 by Cockcroft-Gault, Serum total bilirubin: <1.5 x ULN (unless due to Gilbert's syndrome in which case direct bilirubin must be normal), Serum AST and ALT: <1.5 x ULN in the absence of liver metastases; <3 x ULN if due to liver metastases (in both circumstances bilirubin must meet entry criteria)
  • Ability to understand, and the willingness to sign, a written informed consent document

Exclusion Criteria:

  • Implantation of investigational medical device ≤4 weeks of Treatment visit #1 (Day 1) or current enrollment in oncologic investigational drug or device study
  • Use of investigational drugs ≤4 weeks or <5 half-lives of Treatment visit # 1(Day 1) or current enrollment in investigational oncology drug or device study
  • Prior systemic beta-emitting bone-seeking radioisotopes. Prior radium-223 is allowed provided at least 90 days have lapsed since last dose
  • Prior PSMA-targeted radionuclide therapy (prior PSMA-targeted isotopes used for imaging/diagnostic purposes are allowed, as is prior PSMA-targeted therapy that does not involve therapeutic radionuclides)
  • Known active brain or leptomeningeal metastases
  • History of deep vein thrombosis and/or pulmonary embolus within 1 month of Treatment visit #1
  • Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
  • Radiation therapy for treatment of PC ≤4 weeks of Treatment visit #1
  • Patients on stable dose of bisphosphonates or denosumab, which have been started no less than 4 weeks prior to treatment start, may continue on this medication, however patients are not allowed to initiate bisphosphonate/Denosumab therapy during the DLT-assessment period of the study
  • Having partners of childbearing potential and not willing to use a method of birth control deemed acceptable by the principle investigator and chairperson during the study and for at least 140 days after last study drug administration
  • Currently active other malignancy other than non-melanoma skin cancer. Patients are considered not to have "currently active" malignancy if they have completed any necessary therapy and are considered by their physician to be at less than 30% risk of relapse
  • Known history of myelodysplastic syndrome

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Local Cytoreductive Treatments for Men With Newly Diagnosed Metastatic Prostate Cancer in Addition to Standard of Care Treatment


Condition: Prostate Cancer, Metastatic Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03763253

Sponsor: Imperial College London

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. Diagnosed with prostate cancer within 6 months of screening visit
  2. Metastatic disease (Any T, Any N, M1+) of any grade, stage or Prostate Specific Antigen (PSA) level.
  3. Fit to undergo standard of care treatment for metastatic disease and both minimally invasive therapy and prostate radiotherapy/prostatectomy.
  4. Performance status 0-2
  5. Histologically proven local tumour

Exclusion Criteria:

  1. Patient did not undergo and/or is unable to undergo standard of care baseline imaging tests for confirmation of metastatic status (CT abdomen/pelvis AND chest Xray (or CT chest) AND radioisotope bone scan (or whole body imaging such as MRI or PET imaging as alternative to all preceding scans mentioned here) AND prostate MRI.
  2. Prior exposure to long-term androgen deprivation therapy or hormonal therapy for the treatment of prostate cancer unless started within 4 months of screening visit.
  3. Prior chemotherapy or local or systemic therapy for treatment of prostate cancer (apart from ADT or hormonal therapy as outlined above)

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A Phase II Clinical Study of SHR3680 Combined With Docetaxel in the Treatment of Metastatic Castration-resistant Prostate Cancer Previously Treated With Abiraterone


Condition: Prostate Cancer Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04603833

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. Histologically or cytologically confirmed prostate cancer; Unconfirmed neuroendocrine carcinoma or small cell carcinoma;
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1;
  3. Radiographic evidence of metastasis(CT/MRI/ECT);
  4. Sustained therapy of luteinizing hormone-releasing hormone analogue(LHRHA)or received bilateral orchiectomy; patients who did not receive bilateral orchiectomy are willing to receive sustained therapy of LHRHA;
  5. Evidence of prostate cancer progression under the sustained therapy of LHRHA or bilateral orchiectomy;
  6. Adequate hepatic, renal, heart, and hematological functions;
  7. Patients have given voluntary written informed consent before performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care;
  8. Expected to survive for at least 3 months;
  9. Patient has been treated with Abiraterone and treatment failed;Treatment failure is defined as the progression of disease during treatment;

Exclusion Criteria:

  1. Have received any anti-tumor therapy in the past 4 weeks,including radiotherapy, chemotherapy, operation, targeted therapy, immuntherapy, and endocrinotherapy;
  2. As a subject to participate in other drug clinical trials, the last test drug was administered within 4 weeks from the first dose of the study drug;
  3. Plan to receive any other anti-tumor treatment during this trial;
  4. Subjects have contraindications to prednisone, such as active infections or other conditions;
  5. Subjects present any chronic condition requiring treatment with corticosteroids at doses greater than prednisone 5 mg, BID;
  6. The investigators judged severe bone damage caused by tumor bone metastasis, including severely controlled bone pain, pathological fractures and spinal cord compressions that occurred in the last 6 months or are expected to occur in the near future;
  7. Uncontrolled high blood pressure (systolic blood pressure 160 mmHg or diastolic blood pressure 95 mmHg). If blood pressure can be effectively controlled by antihypertensive therapy, subjects with a history of hypertension are allowed to participate in the study;
  8. Study of active heart disease within 6 months prior to the first dose, including: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, left ventricular ejection fraction <50%, and room for medication Arrhythmia;
  9. Imaging diagnosis of brain tumor lesions;
  10. history of pituitary or adrenal dysfunction;
  11. Study of other malignant tumors within 5 years prior to the first dose (in situ cancer with complete remission and excluding malignant tumors with slow progress);
  12. Patients with active HBV or HCV infection (HBV virus copy number #104 copies/mL, HCV virus copy number #103 copies/mL), or active syphilis infection;
  13. History of immunodeficiency (including HIV positive, other acquired, congenital immunodeficiency disease) or organ transplant history;
  14. Habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease; abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 months before the first dose;
  15. Patients who are unwilling to take effective contraceptive measures during the entire study period and within 3 months after the last dose

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A Phase IIA Study of Sequential ("First Strike, Second Strike") Therapies, Modeled on Evolutionary Dynamics of Anthropocene Extinctions, for High Risk Metastatic Castration Sensitive Prostate Cancer


Condition: Prostate Cancer, Stage IV Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05189457

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Biopsy proven prostate cancer and the diagnosis can be established through either prostate biopsy or biopsy of a metastatic lesion. High risk mCSPC is defined as having 2 of the 3 risk factors: a Gleason score of 8 or more, at least 3 bone metastases, and the presence of measurable visceral metastasis.
  • ECOG performance status of 0-1
  • No androgen deprivation therapy (ADT) with LHRH analogue monotherapy for more than 12 weeks after the diagnosis of metastatic prostate cancer. Prior ADT in the non-metastatic setting is allowed if it was given > 2 years prior to the diagnosis of metastatic prostate cancer and a reduction of PSA is documented after initiating ADT in the metastatic setting.
  • Agreeable to prostate biopsy after completing "second strike".
  • Adequate organ function with absolute neutrophil count > 1000/l, Hb > 10 g/dl, Platelet > 100,000/l, Creatinine and liver enzymes within 1.5 folds of upper limits of normal
  • No uncontrolled arrhythmia; participants with h/o myocardial infarction or history of congestive heart failure, need to have estimated left ventricle ejection fraction above 40% either on echocardiogram or MUGA scan within 6 months of study enrollment.
  • All men who are sexually active with a female partner of childbearing potential treated or enrolled on this protocol must agree to use highly effective barrier contraception prior to the study, for the duration of study participation, and for 7 months after last dose of tislelizumab administration.
  • Ability to understand and the willingness to sign a written informed consent document or have a legally authorized representative sign on the participants behalf. Stated willingness to comply with all study procedures and availability for the duration of the study
  • Inclusion of minorities: Men of all races and ethnic groups who met the above inclusion criteria are eligible for this trial. Exclusion Criteria:
  • Prior treatments with TAK-700/Orteronel, abiraterone, darolutamide, apalutamide or enzalutamide for more than eight weeks.
  • Any previous treatment with a PD-1 or PD-L1 inhibitor
  • Documented brain metastases
  • Prior prostatectomy
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel (including any drugs formulated with polysorbate 80), or LHRH analogue (e.g., leuprolide, triptorelin, goserelin acetate, degarelix)
  • Treatment with any investigational compound within 30 days prior to the first dose of study drugs
  • Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs, or previously diagnosed with another malignancy & have any evidence of residual disease. Participants with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Participants with delayed healing of wounds, ulcers, and/or bone fractures
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome. HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for tislelizumab to be less clinically active in this population.
  • Active or prior documented autoimmune or inflammatory disorders, including inflammatory bowel disease (e.g., Crohn's disease), systemic lupus erythematosus, Sarcoidosis syndrome, Grave's disease, rheumatoid arthritis, hypophysitis, uveitis, with the following exceptions: • Vitiligo or alopecia • Hypothyroidism stable on hormone replacement • Chronic skin condition that does not require systemic therapy • Celiac disease controlled by diet alone • Participants with inactive disease in the last 5 years may be included.
  • Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg]), or hepatitis C (HCV). Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Participants with positive HCV antibody are eligible if polymerase chain reaction is negative for HCV RNA.
  • Concurrent or prior use of immunosuppressive medication within 14 days before the first dose of study chemoimmunotherapy, with the following exceptions: premedication for docetaxel with 8 mg oral dexamethasone approximately 12 hr, 8 hr and 1 hr prior to each docetaxel administration; intranasal, inhaled, topical steroids, or local steroid injections (e.g., intraarticular injection); systemic corticosteroids at physiologic doses not exceeding 10mg/day of prednisone or its equivalent; steroids as premedication for hypersensitivity reactions (e.g., premedication for iodinated contrast allergy before CT scan)
  • History of severe hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
  • Was administered a live vaccine ≤ 4 weeks before first dose of tislelizumab NOTE:Seasonal vaccines for influenza and COVID-19 vaccines are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.
  • Inability to comply with protocol requirements
  • Inclusion of minorities: Men of all races and ethnic groups who met the above

Exclusion Criteria:

  • Prior treatments with TAK-700/Orteronel, abiraterone, darolutamide, apalutamide or enzalutamide for more than eight weeks.
  • Any previous treatment with a PD-1 or PD-L1 inhibitor
  • Documented brain metastases
  • Prior prostatectomy
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel (including any drugs formulated with polysorbate 80), or LHRH analogue (e.g., leuprolide, triptorelin, goserelin acetate, degarelix)
  • Treatment with any investigational compound within 30 days prior to the first dose of study drugs
  • Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs, or previously diagnosed with another malignancy & have any evidence of residual disease. Participants with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Participants with delayed healing of wounds, ulcers, and/or bone fractures
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome. HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for tislelizumab to be less clinically active in this population.
  • Active or prior documented autoimmune or inflammatory disorders, including inflammatory bowel disease (e.g., Crohn's disease), systemic lupus erythematosus, Sarcoidosis syndrome, Grave's disease, rheumatoid arthritis, hypophysitis, uveitis, with the following exceptions: • Vitiligo or alopecia • Hypothyroidism stable on hormone replacement • Chronic skin condition that does not require systemic therapy • Celiac disease controlled by diet alone • Participants with inactive disease in the last 5 years may be included.
  • Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg]), or hepatitis C (HCV). Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Participants with positive HCV antibody are eligible if polymerase chain reaction is negative for HCV RNA.
  • Concurrent or prior use of immunosuppressive medication within 14 days before the first dose of study chemoimmunotherapy, with the following exceptions: premedication for docetaxel with 8 mg oral dexamethasone approximately 12 hr, 8 hr and 1 hr prior to each docetaxel administration; intranasal, inhaled, topical steroids, or local steroid injections (e.g., intraarticular injection); systemic corticosteroids at physiologic doses not exceeding 10mg/day of prednisone or its equivalent; steroids as premedication for hypersensitivity reactions (e.g., premedication for iodinated contrast allergy before CT scan)
  • History of severe hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
  • Was administered a live vaccine ≤ 4 weeks before first dose of tislelizumab NOTE:Seasonal vaccines for influenza and COVID-19 vaccines are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.
  • Inability to comply with protocol requirements
  • Inclusion of minorities: Men of all races and ethnic groups who met the above exclusion criteria are eligible for this trial.

View trial on ClinicalTrials.gov


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VERACITY - Randomized, Active-Controlled, Phase 3 Study of VERU-111 for the Treatment of Metastatic Castration-Resistant Prostate Cancer in Patients Who Have Failed Prior Treatment With at Least One Androgen Receptor Targeting Agent


Condition: Metastatic Castration-resistant Prostate Cancer, Androgen Resistant Prostatic Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04844749

Sponsor: Veru Inc.

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum 100 Years
  • Gender: Male

Inclusion Criteria:

  • Provide informed consent.
  • Be able to communicate effectively with the study personnel.
  • Aged ≥18 years.
  • Histological or cytologic proof of adenocarcinoma of the prostate not including the diagnosis of small cell carcinoma of the prostate of neuroendocrine pathology.
  • Radiographic evidence of metastatic disease at baseline by CT scan, or MRI and bone scan, with confirmation of measurable disease by RECIST 1.1 and/or identifiable discrete bone metastases by PCWG3.
  • Known castration resistant prostate cancer, defined according to PCWG3 criteria.
  • Have received at least one androgen receptor targeting agent (e.g. abiraterone, enzalutamide, darolutamide, or apalutamide).
  • Subjects who have metastatic castration resistant prostate cancer that have maintained ADT and have failed prior treatment with at least one androgen receptor targeting agent (abiraterone,enzalutamide, darolutamide, or apalutamide) defined as:
  • Serum PSA progression of two consecutive increases in PSA over a previous reference value within 6 months of first study treatment, each measurement at least 2 weeks apart. Or
  • Documented bone lesions by the appearance of two or more new lesions on bone scintigraphy or bi-dimensionally-measurable soft tissue metastatic lesion assessed by CT or MRI.
  • Treatment with an alternative androgen receptor targeting agent is a reasonable next line of therapy.
  • Absolute PSA ≥2.0 ng/ml at screening.
  • ECOG performance status <2.
  • Participants must have normal organ and bone marrow function measured within 30 days prior to administration of study treatment as defined below:
  • Hemoglobin ≥9.0 g/dL with no blood transfusion in the past 30 days
  • Creatinine clearance ≥60 mL/min
  • Absolute neutrophil count (ANC) ≥1.5 x 109/L
  • Platelet count ≥100 x 109/L
  • Total bilirubin ≤ upper limit of normal (ULN) (or <2.5 x ULN for patients with known Gilberts disease)
  • Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT))/Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤2.5 x ULN. NOTE: Patients with elevations in bilirubin, AST, or ALT should be thoroughly evaluated for the etiology of this abnormality prior to entry and patients with evidence of viral infection should be excluded. Patients with chronic renal stent and stable creatinine elevation can be included in the study with written documentation from the PI.
  • Participants must have a life expectancy >3 months.
  • Subjects must agree to use acceptable methods of contraception:
  • If the study subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/film/cream/suppository [i.e.,barrier method of contraception], surgical sterilization (vasectomy with documentation of azospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository).
  • If female partner of a study subject has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository)should also be used.-If female partner of a study subject has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS),a barrier method (condom with spermicidal foam/gel/film/cream/suppository)should also be used.
  • Other than metastatic prostate cancer, no evidence (within 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin or other cancers treated with curative intent >3 years prior).
  • Participants must agree to refrain from prolonged exposure to the sun or agree to use at least SPF 50 on all exposed skin and protective clothing during prolonged sun exposure throughout participation in this study and/or treatment with VERU- 111.
  • Subject is willing to comply with the requirements of the protocol through the end of the study.

Exclusion Criteria:

  • Known hypersensitivity or allergy to colchicine.
  • Histologic identification of small cell carcinoma of the prostate or neuroendocrine pathology in either biopsy or prostatectomy tissue.
  • A bone scan with evidence of superscan or superscan phenomenon, defined as:
  • Uptake throughout the axial skeleton and proximal appendicular skeleton, often somewhat heterogeneous, or,
  • Symmetrically intense and diffuse radiotracer uptake in the skeleton with absent or diminished visualization of the genitourinary system and soft tissues, or,
  • Defined in the bone scan report as a superscan or superscan phenomenon. NOTE: Medical Monitor should be consulted prior to screening of a patient if a superscan or superscan phenomenon is suspected or possible, but undetermined by any of the above definitions.
  • Has received external-beam radiotherapy within the last 2 weeks prior to start of study treatment.
  • Patients with a QT interval corrected by Fridericia's formula of >480 ms.
  • Patients receiving full dose warfarin therapy are not eligible for study.
  • Patients with prior history of a thromboembolic event within the last 6 months.
  • Participation in another clinical study with an investigational product during the last 6 months prior to randomization into this study.
  • Patients should be excluded if they have had prior systemic treatment with prior taxane chemotherapies (for greater than 2 cycles) for advanced prostate cancer. Patient can have up to 2 cycles of prior taxane chemotherapy greater than one year prior to randomization and remain eligible for inclusion in this study. Taxane exposure in the adjuvant or neoadjuvant setting is allowed (maximum of 6 cycles).
  • Any treatment modalities involving major surgery within 4weeks prior to the start of study treatment.
  • Patients are excluded if they have known brain metastases or leptomeningeal metastases.
  • Patients should be excluded if they have a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
  • Has imminent or established spinal cord compression based on clinical findings and/or MRI.
  • Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous. Active infections discovered during screening period must be treated and controlled before patient is dosed with VERU-111.
  • Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
  • Poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 6 months) myocardial infarction, uncontrolled major seizure disorder, extensive interstitial bilateral lung disease, or any psychiatric disorder that prohibits obtaining informed consent.
  • Total bilirubin levels > 1.5 x ULN (>2.5 x ULN in patients with known Gilbert's disease).
  • AST and/or ALT levels >2.5xULN or AST and/or ALT levels >1.5xULN WITH concomitant alkaline phosphatase levels >2.5xULN.

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A Phase II Multi-Center Trial of Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer


Condition: Prostate Cancer, Metastatic Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04751929

Sponsor: Dana-Farber Cancer Institute

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Diagnosis of metastatic castration resistant prostate cancer (mCRPC), with histologic confirmation of adenocarcinoma of the prostate (without evidence of small cell carcinoma), with progressive disease at the time of study entry by either
  • Sequence of at least 2 rising PSA values at a minimum of 1-week intervals
  • Radiographic progression per RECIST1.1 for soft tissue and/or per PCWG3 for bone, with or without PSA progression
  • Adult males 18 years of age or older.
  • ECOG performance status of 0 or 1
  • Patients must have metastatic disease by bone scintigraphy or other nodal or visceral lesions on CT or MRI with a bone or soft tissue lesion amenable to image-guided percutaneous biopsy, and the patient must be evaluable for disease response by either
  • Baseline PSA ≥ 2.0 ng/mL OR
  • Measurable disease per RECIST 1.1
  • Past progression or intolerance to at least one novel antiandrogen therapy (abiraterone, enzalutamide, galeterone, apalutamide, darolutamide, orteronel, seviteronel or equivalent) in either the hormone-sensitive or castration-resistant disease setting.
  • Not a candidate for docetaxel or cabazitaxel chemotherapy due to:
  • progression within 12 months of completion or intolerance to prior taxane OR
  • refusal of taxane OR
  • contraindication to, or lack of fitness for taxane OR
  • Investigator assessment that taxane is not clinically indicated or preferred.
  • Maintenance of castration status, defined as serum testosterone level of less than 50 ng/dL. Patients must be surgically castrate or maintained on LHRH agonist or antagonist therapy for the duration of the study period.
  • Must have recovered from any treatment-related toxicities to ≤ CTCAE grade 1.
  • Patients with ≤ CTCAE grade 2 anorexia, alopecia, neuropathy, and/or fatigue however, are also permitted to enroll.
  • Participants must have adequate organ and marrow function as defined below:
  • leukocytes ≥3,000/mcL
  • absolute neutrophil count ≥1,500/mcL
  • hemoglobin ≥9 g/dL (without transfusion or growth factor in prior 28 days)
  • platelets ≥100,000/mcL (without transfusion or growth factor in prior 28 days)
  • total bilirubin ≤1.5 × institutional upper limit of normal, unless the subject has known or suspected Gilbert's syndrome
  • AST(SGOT)/ALT(SGPT) ≤1.5 × institutional upper limit of normal
  • creatinine clearance ≥30 mL/min/1.73 m2
  • Life expectancy of at least 6 months, as determined by a study Investigator.
  • Ability to swallow oral medications.
  • Ability to understand and willingness to sign an IRB-approved informed consent.
  • Additional Inclusion Criteria (Arm C patients)
  • Must have documentation (via CLIA approved, CAP certified next generation sequencing [NGS] assay report) of genomic aberration resulting in CDK12 loss of function in metastatic tumor tissue.
  • Patients whose tumors have not previously undergone NGS are not eligible for Arm C but are eligible for the randomized unselected cohorts.

Exclusion Criteria:

  • Clinical evidence of, or known and untreated metastatic CNS disease.
  • Concurrent active malignancy.
  • Patients with non-melanomatous skin cancer, cancer not needing active therapy for at least 2 years, cancer for which the treating investigator deems the subject to be in remission, or any prior malignancy that was treated with curative intent (no evidence of disease for at least 3 years) are also permitted to enroll.
  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to planned cycle 1 day 1 of study treatment.
  • Patients who have received oral anti-neoplastic intervention such as an oral hormonal agent, PARP inhibitor, AR targeted therapy, or oral experimental agent within 14 days prior to planned cycle 1 day 1 of study treatment.
  • Prior treatment with an inhibitor of CDK4 and/or 6.
  • Prior treatment with an inhibitor of PD-1, PD-L1, or PD-L2.
  • Patients on concurrent therapy with a moderate or strong CYP3A4 inducer or inhibitor which cannot be safely stopped at least five half-lives prior to initiation of therapy with abemaciclib.
  • Evidence of an active autoimmune disease that has required systemic treatment within the last 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
  • Patients with conditions requiring replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are permitted to enroll.
  • Live vaccine within 30 days of registration.
  • Active smoking or a history of smoking greater than 20 pack-years (i.e. # packs of cigarettes smoked per day × # of years patient has smoked > 20).
  • Prior history of radiation therapy to thorax (including to lungs/pleura, esophagus, intrathoracic lymph nodes, C7-L2 vertebrae, or ribs) for any reason and any duration/dose.
  • Any history of interstitial lung disease, pneumonitis or idiopathic pulmonary fibrosis, regardless of remission or immunosuppression status.
  • Any history of lung cancer, regardless of stage or treatment
  • Any of the following abnormalities on pre-treatment pulmonary function testing:
  • FEV1/FVC < lower limit of normal (LLN) and FEV1 < 75% predicted OR
  • FVC < 70% of predicted, regardless of FEV1/FVC ratio OR
  • DLCO (corrected for hemoglobin) < 70% of predicted
  • Active bacterial or fungal infection, or known detectable viral infection (e.g., Human Immunodeficiency Virus [HIV] or viral hepatitis).
  • Arterial or venous thromboembolic event within the last 3 months.
  • Significant infection, medical condition, or social situation which, in the opinion of the investigator, would preclude participation or limit the patient's ability to comply with study requirements.

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Open-label Study of Androgen Receptor Inhibition With dArolutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Men With Metastatic Hormone-Sensitive Prostate Cancer Using an External Control Arm


Condition: Metastatic Hormone-sensitive Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05059236

Sponsor: Bayer

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of prostate. Participants may have begun androgen-deprivation therapy (up to 120 days prior to enrollment). Note: Relugolix is not permitted as ADT in this study.
  • Metastatic disease and will be stratified by presence of high volume or low volume disease.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
  • Adequate bone marrow, liver and renal function within 4 weeks of enrollment
  • At least 4 weeks since prior major surgery and recovered from all toxicity from such surgery prior to enrollment
  • Prior adjuvant or neoadjuvant hormonal therapy allowed provided the following criteria are met:
  • Therapy was discontinued ≥ 12 months ago AND there was a clinical state without evidence of disease at least 12 months after completing adjuvant or neoadjuvant hormonal therapy, as defined by 1 of the following:
  • PSA < 0.1 ng/mL after prostatectomy plus hormonal therapy
  • PSA < 0.5 ng/mL and has not doubled above nadir after radiotherapy plus hormonal therapy
  • Therapy lasted no more than 24 months
  • Prior palliative radiotherapy allowed for participants, if commenced within 30 days before starting androgen deprivation.
  • Bicalutamide, nilutamide or flutamide are allowed as single-agent therapy ≤ 28 days before medical castration to prevent flare.

Exclusion Criteria:

  • PSA met criteria for PSA progression
  • History of malignancy in the past 5 years, with the exception of basal cell and squamous cell carcinoma of the skin.
  • Had any of the following within 6 months before randomization: myocardial infarction, severe/unstable angina pectoris, congestive heart failure, hospitalization for any cardiac event, including conduction abnormalities
  • Pathological finding consistent with small cell, or neuroendocrine carcinoma of the prostate
  • Known brain/ leptomeningeal metastases
  • An active viral hepatitis (defined as Hepatitis B surface antigen [HBsAg] reactive or detectable [qualitative] HBV DNA defined as HCV Ribonucleic Acid [RNA] [qualitative] is detected), known human immunodeficiency virus infection with detectable viral load, or chronic liver disease with a need of treatment
  • Uncontrolled hypertension as indicated by a resting systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite medical management
  • A gastrointestinal (GI) disorder or procedure which is expected to interfere significantly with absorption of study drug
  • Any other serious or unstable illness, or medical, social, or psychological condition, that could jeopardize the safety of the participant and/or his compliance with study procedures or may interfere with the participant's participation in the study or evaluation of the study results.
  • Prior hormone therapy in the metastatic setting
  • Prior chemotherapy in the adjuvant or neoadjuvant setting
  • Concurrent use or previous exposure of 5-alpha reductase inhibitors (within 28 days before the start of darolutamide or 5 half-lives of the drug, whichever is longer)
  • Any Prior treatment with second-generation androgen receptor (AR) inhibitors such as enzalutamide, apalutamide, darolutamide, or other investigational AR inhibitors, Cytochrome P17 enzyme inhibitor such as abiraterone acetate or other investigational CYP 17 as antineoplastic treatment for prostate cancer
  • Previous (within 28 days before the start of darolutamide or 5 half-lives of the investigational treatment of the previous study, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s).
  • Contraindication to both CT and MRI contrast agent
  • Hypersensitivity to any of the study treatments, study treatment classes, or excipients in the formulation of the study treatments
  • Inability to swallow oral medications

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A Phase 2 Course Determining Study for Men With Hormone-Naïve Metastatic Prostate Cancer (HNMPCa)


Condition: Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Prostate Carcinoma Metastatic in the Bone, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03821792

Sponsor: M.D. Anderson Cancer Center

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • At least 2 of the 3 following high-risk prognostic factors:
  • Gleason score of >= 8
  • Presence of 3 or more lesions on bone scan
  • Presence of measurable visceral (excluding lymph node disease) metastasis on computed tomography (CT) or magnetic resonance imaging (MRI) (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
  • Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • Hemoglobin >= 9.0 g/dL independent of transfusion and/or growth factors within 3 months prior to enrollment
  • Platelet count >= 100,000/uL independent of transfusion and/or growth factors within 3 months prior to enrollment
  • Serum albumin >= 3.0 g/dL
  • Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Calculated creatinine clearance (Cockcroft-Gault equation) >= 45 mL/min
  • Serum potassium >= 3.5 mEg/L
  • Serum magnesium >= 1.6 mg/dL
  • Serum bilirubin < 1.5 x institutional upper limit of normal (IULN) (except for patients with known Gilbert's disease if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
  • Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x IULN for patients without liver metastases. (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible. For patients with liver metastases AST or ALT < 4 x IULN is allowed)
  • Able to swallow study drugs whole as a tablet/capsule
  • Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug
  • Patients must agree to tissue collection for correlative studies at the specified time points

Exclusion Criteria:

  • Small cell prostate cancer
  • Treatment within 28 days of cycle 1 day 1: Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer. The following exceptions are permitted:
  • Up to 3 months of antiandrogen therapy (ADT) with LHRH agonists or antagonists or orchiectomy with or without concurrent anti-androgens prior to cycle 1 day 1. Anti-androgens (flutamide, bicalutamide or nilutamide) for subjects receiving an LHRH agonist must be discontinued within 2 weeks of cycle 1 day 1, or subjects may have one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease (e.g., impending cord compression or obstructive symptoms) if it was administered at least 28 days prior to cycle 1 day 1. All adverse events associated with these procedures must be resolved at least to grade 1 by cycle 1 day 1, or
  • Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone daily. Use of inhaled, intranasal, intra-articular and topical steroids are acceptable, as is a short course (i.e. =< 1 day) of corticosteroids to prevent a reaction to the intravenous (IV) contrast used for CT scans
  • Active infection (requiring oral or IV antibiotics or antiviral therapy) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • A malignancy (other than the one treated in this study) which required radiotherapy or systemic treatment within the past 5 years, or has a >= 30% probability of recurrence within 24 months (except for non-melanoma skin cancer or Ta urothelial carcinomas)
  • Chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 170 or diastolic pressures above 110 despite anti-hypertensive therapy. Note that this is NOT a criterion related to particular blood pressure (BP) results at the time of assessment for eligibility, nor does it apply to acute BP excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes. (For example doctor's visit related stress i.e. "white coat syndrome")
  • Prolonged corrected QT interval by Fridericia's formula (QTcF) interval on pre-entry electrocardiogram (>= 450 msec)
  • Known active or symptomatic viral hepatitis or chronic liver disease
  • Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsade de pointes), New York Heart Association class III-IV heart disease or cardiac ejection fraction measurement of < 40% at baseline
  • Patients who have had a history of illness which put them at current risk for bowel perforation such as acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis
  • Baseline moderate and severe hepatic impairment (Child Pugh class B & C)
  • Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system [CNS] or meningeal disease which may require treatment with surgery or radiation therapy)
  • Gastrointestinal disorder affecting absorption
  • Untreated symptomatic spinal cord compression
  • Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events

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A Phase 1, Three-Part, Open-Label, Parallel-Cohort Safety and Tolerability Study of Relugolix in Combination With Abiraterone Acetate Plus a Corticosteroid, Apalutamide, or Docetaxel With or Without Prednisone in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer


Condition: Metastatic Castration-Resistant Prostate Cancer, Metastatic Castration-Sensitive Prostate Cancer, Non-Metastatic Castration-Resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04666129

Sponsor: Myovant Sciences GmbH

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Key Inclusion Criteria:

  • 1. A diagnosis of adenocarcinoma of the prostate confirmed by histologic or cytologic evidence and with a documented medical history of either:
  • mCSPC (Parts 1, 2, and 3) defined as having at least two of three risk factors at the baseline (Day 1) visit:
  • Total Gleason score of ≥ 6;
  • Presence of ≥ 2 metastatic lesions on bone scan;
  • Evidence of measurable visceral metastases with exception of hepatic metastases.
  • nmCRPC (Part 2 only) defined as disease progression despite maintaining castration levels of testosterone with androgen deprivation therapy (ADT), as evidenced by an increase in consecutive prostate-specific antigen (PSA) concentrations of ≥ 2 ng/mL (2 measurements, at least one week apart).
  • mCRPC (Parts 1 and 3) defined as disease progression despite maintaining castration levels of testosterone with ADT:
  • An increase in PSA ≥ 25% and ≥ 2 ng/mL above the nadir, confirmed by 2 measurements at least 3 weeks apart, and;
  • The progression of pre-existing disease as evidenced either by worsening symptoms and/or enlarged metastatic lesions; and/or;
  • The development of new metastases. 2. Currently receiving standard-of-care treatment of leuprolide acetate (3-, 4-, or 6-month injections [intramuscular Lupron or subcutaneous Eligard]) or a gonadotropin-releasing hormone (GnRH) receptor antagonist (such as degarelix) in combination with:
  • Part 1: abiraterone acetate 1000 mg or fine-particle abiraterone acetate 500 mg once daily plus prednisone 5 mg once daily for participants with mCSPC or twice daily for participants with mCRPC or methylprednisolone 4 mg once daily and in whom abiraterone has been well tolerated (that is, without evidence of hepatotoxicity requiring dose adjustment for abiraterone) for a minimum of 12 weeks prior to initiation of the study treatment period.
  • Part 2: apalutamide 240 mg once daily and in whom apalutamide has been well tolerated (that is, without a fracture, fall, or seizure episode or need to dose adjust due to any adverse events) for a minimum of 6 weeks prior to initiation of the study treatment period.
  • Part 3: docetaxel 75 mg/m2 and in whom docetaxel has been well tolerated (that is, no evidence of hypersensitivity reaction, febrile neutropenia or neutrophils < 500 cells/mm3 for more than 1 week, severe or cumulative cutaneous reactions, or moderate neurosensory signs and/or symptoms despite dose reduction) for a minimum of 1 previous treatment cycle.

Key Exclusion Criteria:

  • 1. Received treatment with a GnRH analog or GnRH receptor antagonist with either abiraterone acetate plus a corticosteroid (Part 1) or apalutamide (Part 2) in mCSPC participants (Parts 1 and 2) or nmCRPC (Part 2) for a total duration > 24 months or in mCRPC participants (Part 1) for a total duration > 6 months. 2. Abnormal clinical laboratory test value(s) suggestive of clinically unstable underlying disease or a clinical laboratory test value(s) at the screening visit or prior to the baseline (Day 1) visit including:
  • (Part 1 only) Serum alanine aminotransferase and/or aspartate aminotransferase > upper limit of normal (ULN) (confirmed twice during screening at least 14 days apart);
  • (Part 3 only) Serum alanine aminotransferase and/or aspartate aminotransferase > 1.5 times ULN concurrently with an alkaline phosphatase > 2.5 times ULN;
  • (Part 1 only) Total bilirubin > ULN (unless values are consistent with Gilbert's syndrome for which the total bilirubin cannot exceed > 3 times ULN);
  • (Part 3 only) Total bilirubin > ULN
  • (Part 1 only) Potassium < 3.5 milliequivalents/liter;
  • Serum creatinine > 2.0 mg/dL;
  • Platelets < 100 × 10^3/microliter (μL);
  • Hemoglobin < 10.0 grams/dL;
  • Leukocytes < 3 × 10^3/μL;
  • Absolute neutrophil count < 1.5 × 10^3/μL;
  • Hemoglobin A1c > 8%. 3. A medical history within 6 months prior to the screening visit of the following (myocardial infarction; unstable angina; unstable symptomatic ischemic heart disease; New York Heart Association class III or IV heart failure; thromboembolic event[s]), any other significant cardiac conditions, stroke (Part 2 only), transient ischemic attack (Part 2 only), or medical history of seizures (Part 2 only). 4. An abnormal electrocardiogram finding 5. Uncontrolled hypertension 6. Hypotension 7. Bradycardia

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A Phase 2 Study of Nivolumab in Patients With High-Risk Biochemically Recurrent Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03637543

Sponsor: Beth Israel Deaconess Medical Center

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Patients must have signed an informed-consent form indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study.
  • Patients must have a history of prostate adenocarcinoma (adenocarcinoma must be the primary histology; secondary components of variant histologies are acceptable) confirmed on biopsy and treated with primary radical prostatectomy (RP) or definitive radiation (RT). Prior salvage RT is acceptable.
  • Patients must have experienced biochemical recurrence (BCR) plus have minimum PSA values noted below:
  • Following primary RP: Any detectable rising PSA after RP (or after salvage RT if performed), minimum PSA 1.0 at time of screening
  • Following primary RT: PSA rise to ≥2 ng/mL above the nadir
  • No evidence of metastases on conventional imaging (CT or MRI plus bone scan)
  • PSA doubling time (PSADT) <10 months --PSADT: calculated as per Prostate Cancer Working Group 3 (PCWG3) and the Memorial Sloan Kettering Cancer Center calculator: (https://www.mskcc.org/nomograms/prostate/psa_doubling_time) With linear regression model of normal logarithm of PSA and time, based on:
  • At least 3 consecutive PSA values with each value ≥0.2 ng/mL
  • Interval between first and last PSA values is ≥8 weeks but ≤12 months. -Archival tissue is mandatory, either prostatectomy specimen or (in patients who received primary RT) diagnostic core biopsies. Patients must consent to next-generation sequencing performed on this tissue.
  • If diagnostic core biopsies are only available tissue, at least 3 cores must be involved by tumor
  • Easteron Cooperative Oncology Group (ECOG) performance status 0-1
  • Age ≥18 years
  • Adequate organ and marrow function:
  • System Laboratory Value
  • Hematological
  • White blood cell (WBC) ≥ 2000/µL
  • Absolute Neutrophil Count (ANC) ≥ 1500/μL
  • Platelets (Plt) ≥ 100 x103/μL
  • Hemoglobin (Hgb) > 9.0 g/dL (with or without transfusion) -Renal
  • Serum Creatinine ≤ 2 x ULN
  • Hepatic
  • Bilirubin1 ≤ 1.5× upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) ≤ 3 × ULN
  • Alanine aminotransferase (ALT) ≤ 3 × ULN
  • Except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL
  • Baseline testosterone ≥100 ng/dL
  • Recovery from acute toxicity related to prior therapy, including surgery and radiation, or no treatment-related toxicity ≥ grade 2.
  • History of prior malignancy or concurrent separate malignancy is not an exclusion criterion so long as the non-prostate malignancy is stable and does not require any treatment.
  • Able to understand and sign informed consent and adhere to study procedures.
  • Male patients whose female partners are of reproductive potential must agree to use a contraception during the trial period

Exclusion Criteria:

  • Current use of ADT or plan to initiate ADT during trial period
  • Major surgery or radiation therapy within 14 days of starting study treatment
  • Subjects with active autoimmune disease. Patients with a history of autoimmune disease that has not required systemic immunosuppressive therapy or does not threaten vital organ function including central nervous system, heart, lungs, kidneys, skin, and gastrointestinal tract will be allowed.
  • Known history of immune deficiencies or chronic viral infections including HIV, hepatitis B (HBV), and hepatitis C (HCV) (patients with prior therapy for HBV or HCV is permitted if viral clearance was documented).
  • Concurrent medical condition requiring use of systemic corticosteroids with prednisone >10 mg per day or equivalent. Use of inhaled, nasal, and topical steroids (applied to small body areas) is allowed.
  • Current use (within past 4 weeks) of other prohibited medications including anti-cancer therapies, hormonal therapies, 5-alpha reductase inhibitors, and alternative medications known to alter PSA (e.g. phytoestrogens and saw palmetto).
  • Prior treatment with immune checkpoint inhibitors. (Prior cancer vaccines are allowed.)
  • Serious intercurrent medical or psychiatric illness that, in the judgment of the investigator, would interfere with patient's ability to carry out the treatment program

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The BARCODE 1 Study: The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening.


Condition: Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03857477

Sponsor: Institute of Cancer Research, United Kingdom

Phase:

Eligibility:

  • Age: minimum 55 Years maximum 69 Years
  • Gender: Male

Inclusion Criteria:

  • Men aged 55 to 69 years.
  • Caucasian ethnicity.
  • WHO performance status 0-2.
  • Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.

Exclusion Criteria:

  • Non-Caucasian ethnicity (including mixed race or Ashkenazi Jewish (excluded as these groups have different genetic risk profiles from those being studied).
  • Previous diagnosis of cancer with a life-expectancy of less than five years.
  • Negative prostate biopsy within one year before recruitment.
  • Previous diagnosis of prostate cancer.
  • Co-morbidities making prostate biopsy risk unacceptable (anticoagulants or antiplatelet medication including Warfarin, Clopidogrel, Apixaban, Dabigatran or other NOAC medications (Novel Oral Anti-Coagulant); poorly controlled diabetes, cardiovascular/respiratory disease, immunosuppressive medication or splenectomy).
  • Men with body mass index (BMI) 40 and above.
  • Men with BMI 35 and above plus other co-morbidities.
  • Contraindications to having an MRI (pacemakers, aneurysm clips, metallic cardiac valve/stent, Ventriculo-Peritoneal (VP) shunt, cochlear implant, neurotransmitter, metallic foreign bodies in eye(s), other metalwork, claustrophobia).
  • Any significant psychological conditions that may be worsened or exacerbated by participation in the study.

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A Parallel Arm Phase 1b/2a Study of DKN-01 as Monotherapy or in Combination With Docetaxel for the Treatment of Advanced Prostate Cancer With Elevated DKK1


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03837353

Sponsor: NYU Langone Health

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 100 Years
  • Gender: Male

Inclusion Criteria:

  • Have a histologically or cytologically confirmed prostate adenocarcinoma or poorly differentiated carcinoma of the prostate
  • Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM). If the patient is being treated with luteinizing hormone-releasing hormone (LHRH) agonists (patient who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to C1D1 and must be continued throughout the study.
  • Cohorts 1A, 1B, and 1C. Patients must have received 1 or more androgen receptor (AR) signaling inhibitors (abiraterone or enzalutamide) and have not received prior taxane-based chemotherapy for prostate cancer. Prior treatment with an AR signaling inhibitor for castration-sensitive disease will be allowed if the time to progression was within 1 year after starting drug. Prior treatment with a taxane-based chemotherapy for castration-sensitive disease will be exclusionary.
  • Cohorts 2A and 2B. Patients must have received 1 or more AR signaling inhibitor (abiraterone or enzalutamide) and either had disease progression, were intolerant of, or refused 1 or more taxane-based chemotherapies for mCRPC.
  • Patients must be DKK1-high as determined by either: 1. Elevated DKK1 RNA expression in ≥1% of cells as defined by central laboratory testing of a fresh biopsy or archival specimen OR 2. DKK1 protein level in peripheral blood plasma that is above the reference limit of a cohort of healthy male controls as established by central laboratory testing
  • Cohort 1B. Patients must have progression of measurable disease per mRECIST v1.1 guidelines.
  • Cohort 1C. Patients must have progression of disease defined as one of the following: 1. PSA progression is defined by Prostate Cancer Working Group 3 (PCWG3) criteria as a minimum of two consecutive rising levels, with an interval of ≥1 week between each determination with a minimum PSA of 2 ng/mL. 2. Radionuclide bone progression as defined by at least two new metastatic lesions (per PCWG3).
  • Cohorts 1A, 2A, 2B. Patients must have baseline progression defined as one of the following: 1. PSA progression is defined by PCWG3 criteria as a minimum of two consecutive rising levels, with an interval of ≥1 week between each determination with a minimum PSA of 2 ng/mL. 2. Radionuclide bone progression as defined by at least two new metastatic lesions (per PCWG3). 3. Soft tissue progression on transaxial imaging: new or progressive soft tissue masses on computed tomography (CT) or magnetic resonance imaging (MRI) scans as defined by mRECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Estimated life expectancy of at least 3 months, in the judgment of the Investigator.
  • Disease-free of active second/secondary or prior malignancies for ≥2 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast.
  • Required initial laboratory values within 14 days of C1D1: 1. Total bilirubin within normal limits for the institution. (For Cohorts 2A and 2B, total bilirubin < 3 × ULN is acceptable with known liver metastases). 2. Transaminases [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)] ≤1.5 × the upper limit of normal (ULN) OR alkaline phosphatase ≤2.5 × ULN (For Cohorts 2A and 2B, AST and ALT and alkaline phosphatase ≤ 5.0 × ULN is acceptable with known liver metastases). 3. Creatinine ≤2.0 or calculated creatinine clearance ≥50 mL/min using the Cockcroft and Gault Method (Cockroft and Gault 1976). 4. Absolute neutrophil count ≥1000 cells/μl. 5. Absolute lymphocyte count ≥500/μl. 6. Hemoglobin ≥9.0 g/dL. 7. Platelet count ≥100,000 cells/μl. (For Cohorts 2A and 2B, Platelet count ≥75,000 cells/μl). 8. International normalized ratio (INR) (prothrombin time [PT])/ partial thromboplastin time (PTT) ≤1.2 × ULN unless receiving anticoagulant, in which case INR ≤3.0 and no active bleeding, (ie, no clinically significant bleeding within 14 days prior to first dose of study therapy.
  • Sexually active male patients must agree to use adequate contraception (hormonal or barrier method of birth control) during the study and for 6 months after their last dose of study drug. Should a patient's partner become pregnant or suspect she is pregnant while participating in the study, the Investigator should be immediately informed.
  • Reliable and willing to make themselves available for the duration of the study and are willing to follow study-specific procedures.
  • Provided written informed consent prior to any study-specific procedures.

Exclusion Criteria:

  • Any anti-cancer therapy (with the exception of luteinizing hormonereleasing hormone [LHRH] analog or antagonist) within 2 weeks prior to initiation of study treatment.
  • Any investigational anti-cancer therapy within 4 weeks of initiation of study treatment.
  • Histological small cell or pure neuroendocrine carcinoma that has not yet been treated with at least one line of platinum-based chemotherapy (Prostate adenocarcinoma with immunohistochemical neuroendocrine differentiation but without histological small cell that is naïve to platinumbased chemotherapy will be allowed.)
  • New York Heart Association Class III or IV heart failure, or myocardial infarction within the past 6 months, or unstable arrhythmia within 3 months.
  • Uncontrolled bacterial, viral, or fungal infections, within 7 days of study entry.
  • Known to be human immunodeficiency virus (HIV) positive, have positive hepatitis B surface antigen (HBSAg), or positive hepatitis C antibody (HCAb) test. (Hepatitis C antibody-positive patients with an undetectable hepatitis C virus (HCV) RNA will be eligible.)
  • History of solid organ transplant (ie, heart, lungs, liver, or kidney).
  • History of autologous/allogenic bone marrow transplant.
  • Serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator and/or Sponsor.
  • Major surgical procedures or significant traumatic injury within 4 weeks prior to study entry (minor procedures within 1 week of study entry).
  • History of osteonecrosis of the hip. Other hip pathology such as degenerative disease or malignant involvement are not exclusionary. Screening of asymptomatic patients is not required.
  • Active or untreated central nervous system (CNS) malignancy or metastasis. Screening for CNS metastases of asymptomatic patients without a history of CNS metastases is not required. Patients with treated
  • CNS metastases are eligible provided they meet all of the following criteria: 1. Evaluable disease outside the CNS. 2. No history of intracranial or intraspinal hemorrhage. 3. No evidence of significant vasogenic edema. 4. No ongoing requirement for corticosteroids as therapy for CNS disease. (Anti-convulsants at a stable dose for > one month is allowed.) 5. No stereotactic radiation, whole brain radiation within 4 weeks of C1D1. 6. Patients with CNS metastases treated by neurosurgical resection or brain biopsy within 3 month prior to C1D1 will not be allowed. 7. Radiographic demonstration of interim stability (ie, no progression) between completion of CNS-directed therapy and the screening radiographic study. 8. Screening CNS radiographic study ≥4 weeks since completion of radiotherapy or surgical resection and ≥2 weeks since discontinuation of corticosteroids.
  • Any other condition, disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
  • Active substance abuse.
  • Receipt of any live vaccine within 30 days before the first dose of study treatment or anticipation that such a live vaccine will be required during study.
  • Previously treated with an anti-DKK1 therapy.

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Protocol for the Development of a Machine Learning Model for Prostate Cancer Treatment Planning


Condition: Prostate Cancer, Artificial Intelligence, Radiotherapy

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04441775

Sponsor: Dartmouth-Hitchcock Medical Center

Phase:

Eligibility:

  • Age: minimum 21 Years maximum 90 Years
  • Gender: Male

Inclusion Criteria:

  • Favorable-risk inclusion criteria (as per RTOG 0415) 1. Histologically confirmed prostate adenocarcinoma 2. Gleason Score <= 3+4 = 7 ( with less than 50% of all cores positive, and no more than one core with Gleason 3+4=7) 3. Clinical stage T1-T2b 4. Prostate Specific Antigen (PSA) <10 ng/ml within 180 days prior to treatment planning. PSA may not have been acquired within 30 days of stopping finasteride, or within 90 days of stopping dutasteride 5. RT treatment initiated between 1/1/15 and 12/31/16 6. Prostate MRI used as part of RT treatment planning 7. No previous hormonal therapy, such as LHRH agonists, estrogens, anti-androgens, or surgical castration 8. No previous use of finasteride within 30 days prior to planning 9. No previous use of dutasteride within 90 days prior to planning
  • High-risk inclusion criteria (as per RTOG 0521) 1. Histologically confirmed prostate adenocarcinoma 2. PSA < 150 3. One of the following combinations: 1. Gleason 7 or 8 and PSA >= 20 2. Gleason 8 and clinical T-stage > T2a 3. Gleason 9 or 10 4. Negative bone scan within 180 days of planning 5. XRT treatment initiated between 1/1/15 and 12/31/16 6. Prostate MRI used as part of RT treatment planning 7. No previous hormonal therapy, such as LHRH agonists, estrogens, anti-androgens, or surgical castration, prior to prostate cancer diagnosis
  • Intermediate-risk inclusion criteria 1. Histologically confirmed prostate adenocarcinoma 2. PSA < 20 3. Gleason 7 or 8 4. Not meeting criteria for favorable- or high-risk disease, as per above 5. XRT treatment initiated between 1/1/15 and 12/31/16 6. Prostate MRI used as part of RT treatment planning 7. No previous hormonal therapy, such as LHRH agonists, estrogens, anti-androgens, or surgical castration, prior to prostate cancer diagnosis

Exclusion Criteria:

  1. Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years
  2. Evidence of distant metastases
  3. Regional lymph node involvement
  4. Previous radical prostate surgery or cryosurgery
  5. Previous pelvic irradiation or prostate brachytherapy
  6. Previous or concurrent cytotoxic chemotherapy for prostate cancer
  7. Severe, active comorbidity, defined as follows:
  8. Unstable angina, congestive heart failure, and/or transmural myocardial infarction requiring hospitalization within the last 6 months
  9. Acute bacterial or fungal infection requiring intravenous antibiotics
  10. Hepatic insufficiency resulting in clinical jaundice or coagulopathy
  11. Acquired immune deficiency syndrome based upon current CDC-defined criteria
  12. Zubrod performance status 2 or worse
  13. Previous use of finasteride within 60 days of planning
  14. Previous use of dutasteride within 180 days of planning

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Early Detection of Prostate Cancer by Liquid Biopsy


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04556916

Sponsor: University Hospital, Montpellier

Eligibility:

  • Age: minimum 40 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Patient :
  • Men over 40 being suspicious of prostate cancer
  • Subject with PSA ≥ 4 and designated for biopsy
  • Subjects must be able to attend all scheduled visits and to comply with all trial procedures
  • mpMRI done before prostate biopsy
  • Subject must be covered by public health insurance
  • Signed informed consent form Inclusion Criteria Subject Control Patient patient free from prostatic disease :
  • Men over 40 with no suspicion of prostate cancer
  • Subject with PSA < 2.5 and normal digital rectal examination
  • Subject must be covered by public health insurance
  • Signed informed consent form Exclusion Criteria Patient :
  • Subject with histologically confirmed prostate cancer
  • Subject with a verified viral infection (HIV or Hepatitis)
  • Subject under Finasteride treatment
  • Subject under hormonal treatment (analogs, antagonists, androgenics)
  • Subject with other cancer diagnosed
  • Subject unable to sign consent
  • Planned longer stay outside the region that prevents compliance with the visit plan
  • Subject deprived of liberty, protected adults or vulnerable persons
  • Urinary infection ≤ 2 months
  • Subject excluding health insurance registration
  • Subject refusing to perform prostate biopsy
  • Subject who are in a dependency or employment with the sponsor or the investigator

Exclusion Criteria:

  • Patient :
  • Subject with histologically confirmed prostate cancer
  • Subject with a verified viral infection (HIV or Hepatitis)
  • Subject under Finasteride treatment
  • Subject under hormonal treatment (analogs, antagonists, androgenics)
  • Subject with other cancer diagnosed
  • Subject unable to sign consent
  • Planned longer stay outside the region that prevents compliance with the visit plan
  • Subject deprived of liberty, protected adults or vulnerable persons
  • Urinary infection ≤ 2 months
  • Subject excluding health insurance registration
  • Subject refusing to perform prostate biopsy
  • Subject who are in a dependency or employment with the sponsor or the investigator Exclusion Criteria Subject Control :
  • Subject with histologically confirmed prostate cancer
  • Subject with a verified viral infection (HIV or Hepatitis)
  • Subject under Finasteride treatment
  • Subject with other cancer diagnosed
  • Subject unable to sign consent
  • Planned longer stay outside the region that prevents compliance with the visit plan
  • Subject deprived of liberty, protected adults or vulnerable persons
  • Urinary infection ≤ 2 months
  • Subject excluding health insurance registration

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A Phase 1, Open-label Study in Two Parts, Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of CCW702 in Patients With Metastatic, Castration Resistant Prostate Adenocarcinoma


Condition: Castration-Resistant Prostatic Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04077021

Sponsor: Calibr, a division of Scripps Research

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Men ≥ 18 years of age at time of informed consent
  • For Part 1 and Part 2: men with metastatic castration resistant prostate cancer (mCRPC) with histologically or cytologically confirmed adenocarcinoma of the prostate as defined by one or more of the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria
  • Patients with treated brain metastasis or LMD are eligible if brain imaging shows no evidence of progression
  • Must have prostate-specific antigen (PSA) and/or radiographic progression on AT LEAST One novel androgen receptor (AR)-targeted therapy (abiraterone acetate, enzalutamide).
  • Eastern Cooperative Oncology Group performance status of 0-1
  • Adequate liver function
  • Adequate hematopoietic function
  • Testosterone level ≤ 50 ng/mL (or 1.73 nmol/L)
  • Patient has a life expectancy of greater than 12 weeks

Exclusion Criteria:

  • Patients whose tumors solely exhibit neuroendocrine differentiation or small cell features by histopathology
  • Patients with new or progressive brain metastasis or Leptomeningeal Disease (LMD)
  • Patients with a history of clinically significant cardiovascular disease such as symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, history of stroke or myocardial infarction within 6 months of enrollment
  • Patients with peripheral neuropathy CTCAE Grade >/= 2
  • Patients with a known history of hypersensitivity, allergy or intolerance to CCW702 or its excipients
  • Patients with untreated or imminent spinal cord compression

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68Ga-PSMA-11 PET in Patients With Prostate Cancer


Condition: Biochemically Recurrent Prostate Carcinoma, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04777071

Sponsor: University of Washington

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Pathologically proven prostate adenocarcinoma
  • For the initial staging arm, high risk characteristics, including any of the following:
  • Grade group 4-5 and/or
  • PSA > 20 ng/mL
  • For patients with biochemical recurrence:
  • Rising PSA after definitive therapy with prostatectomy or targeted local therapy (including but not limited to external beam radiation therapy, brachytherapy, high-frequency ultrasound, and cryotherapy)
  • If post-radical prostatectomy, PSA > 0.2 ng/mL measured > 6 weeks post-operatively and confirmatory persistent PSA greater than 0.2 ng/mL (American Urological Association (AUA) definition for biochemical recurrence
  • If post-radiation therapy, PSA that is equal to, or greater than, a 2 mg/mL rise above PSA nadir (American Society of Radiation Oncology (ASTRO) definition for biochemical recurrence)
  • For patients undergoing systemic therapy:
  • Diagnosis of metastatic castration-resistant prostate cancer
  • At least one or more measurable (> 1 cm diameter in short axis) or evaluable lesions by conventional imaging
  • Any patient with an equivocal lesion by conventional imaging, regardless of where they are in the course of evaluation or treatment
  • No other malignancy within the past 2 years (with the exception of skin basal cell or cutaneous superficial squamous cell carcinoma, superficial bladder cancer, carcinoma in situ in any location, or Rai Stage 0 chronic lymphocytic leukemia, which are allowed)
  • Karnofsky performance status (KPS) >= 50, Eastern Cooperative Oncology Group/World Health Organization (ECOG/WHO) grades 0, 1, or 2
  • Ability to understand and willingness to provide informed consent

Exclusion Criteria:

  • Allergy to furosemide
  • History of Stevens-Johnson syndrome
  • History or diagnosis of Paget's disease
  • Allergy to sulfa or sulfa-containing medications
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

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Combination of Nivolumab Immunotherapy With Radiation Therapy and Androgen Deprivation Therapy in the Management of Gleason Group 5 Prostate Cancer


Condition: Prostate Cancer, Prostate Disease

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03543189

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Male, aged ≥ 18 years
  • ECOG Performance Status: 0-1
  • Diagnosed with Grade Group 5 prostate cancer (PCa): Gleason grade 9 (4+5 or 5+4) or 10 (5+5) with >30% of cores involved; Any PSA or T-stage
  • Pathologically (histologically) proven diagnosis of PCa undergoing their first line of treatment
  • Biopsy specimen available
  • Patients with oligometastaic disease (defined as ≤3 sites of distant metastatic disease, and/or positive lymph nodes confined to the pelvis) being treated with curative intent are eligible for study participation
  • Eligible for definitive RT (HDR + EBRT) + short-term ADT
  • Undergoing radiation treatment at Moffitt Cancer Center
  • Participants being treated with nivolumab must have normal organ function as defined in protocol.
  • Males who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of the study drug (half-life up to 25 days) plus 90 days (duration of sperm turnover) for a total of 31 weeks post-treatment completion; Azoospermic males are exempt from contraceptive requirements; Male participants must be willing to refrain from sperm donation during the entire study and for 5 half-lives of study drug plus 90 days (duration of sperm turnover).

Exclusion Criteria:

  • Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener's Granulomatosis]) and motor neuropathy considered to be of autoimmune origin (e.g., Guillain-Barre Syndrome and Myasthenia Gravis). Patients with Hashimoto's thyroiditis are eligible to go on study. Active, known, or suspected autoimmune disease. Patients with an autoimmune paraneoplastic syndrome requiring concurrent immunosuppressive treatment are excluded. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
  • A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study entry. Corticosteroids with minimal systemic absorption (inhaled or topical steroids) and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease
  • Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways)
  • Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
  • Previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, melanoma, or breast) unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period
  • Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results
  • Major surgery or significant traumatic injury that is not recovered at least 14 days before the initiation of prostate radiation therapy
  • Positive test for hepatitis B virus (HBV) using HBV surface antigen (HBVsAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection
  • Individuals with a positive test for HCV antibody but no detection of HCV RNA indicating no current infection are eligible
  • Known medical history of testing positive for human immunodeficiency virus (HIV) or known medical history of acquired immunodeficiency syndrome (AIDS)
  • Inadequate hematologic function; hepatic function; pancreatic function
  • History of allergy or hypersensitivity to any of the study drugs or study drug components.
  • Uncontrolled intercurrent illnesses including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness.
  • Social situations that could limit the patient's compliance with study requirements.

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A Multicenter, Open-Label, Exploratory Platform Study to Evaluate Biomarkers and Immunotherapy Combinations for the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer


Condition: Metastatic Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03835533

Sponsor: Parker Institute for Cancer Immunotherapy

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Key Inclusion Criteria:

  1. Metastatic castration resistant prostate cancer with castrate-level testosterone (< 50 ng/dL) at screening.
  2. Disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria.
  3. Provide fresh pre-treatment core needle or incisional biopsy of a metastatic tumor lesion not previously irradiated. Fine needle aspiration is not acceptable.
  4. Additionally, if a pre-treatment biopsy is not medically feasible for participants with bone only disease, formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 10 slides containing unstained, freshly cut, serial sections must be provided.
  5. For all participants, in addition to fresh pre-treatment biopsy, consent for archival tissue is required.
  6. Must be willing to undergo tumor biopsy(ies) on treatment, if medically feasible.
  7. Have received and progressed on prior secondary androgen receptor signaling inhibitor therapy (eg, abiraterone, enzalutamide, apalutamide).
  8. Participants must discontinue antiandrogen therapy (ie, bicalutamide, flutamide, nilutamide) at least 4-6 weeks prior to registration with no evidence of PSA decline after washout.
  9. Bicalutamide: Washout period at least 6 weeks
  10. Flutamide and nilutamide: Washout period at least 4 weeks
  11. Participants must discontinue therapies for mCRPC for 5 half-lives or 28 days, whichever is shorter.
  12. Participants will remain on gonadotropin-releasing hormone (GnRH) agents throughout this study.
  13. Prior chemotherapy is allowed if no progression of disease on chemotherapy as defined by PCWG3-modified RECIST 1.
  14. Prior treatment with sipuleucel-T, radium-223, or poly ADP ribose polymerase (PARP) inhibitor (eg, olaparib) is allowed.
  15. Tissue biopsy may be performed during washout period.

Key Exclusion Criteria:

  1. Has a diagnosis of immunodeficiency or conditions that need systemic corticosteroid replacement therapy > 10 mg/day prednisone (or equivalent) or other immunosuppressive medications within 28 days prior to the first dose of study intervention. Inhaled steroids are permitted if necessary.
  2. Has any active known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, controlled autoimmune hypothyroidism, psoriasis not requiring systemic treatment, or other conditions under control are permitted to enroll.
  3. Has a known history of active TB (Bacillus Tuberculosis).
  4. Has known history of, or any evidence of active, non-infectious pneumonitis.
  5. Known history of testing positive for human immunodeficiency virus (HIV), known acquired immunodeficiency syndrome (AIDS), or any positive test for hepatitis B or hepatitis C virus representing acute or chronic disease.
  6. Has received a live vaccine within 30 days of planned start of study intervention. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (eg, Flu-Mist®) are live attenuated vaccines, and are not allowed.
  7. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of study intervention and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to study intervention. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.

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A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men With Prostate Cancer (VANDAAM Study)


Condition: Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02723734

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Phase:

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Adult patients with Karnofsky Performance Status >70
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • Pathologically (histologically) proven diagnosis of prostate cancer (PCa) undergoing their first line of treatment
  • Meet National Comprehensive Cancer Network (NCCN) criteria for either: Low risk PCa (defined as Gleason score 6 in ≥ 3 cores; T-stage T1c- T2a); Intermediate risk PCa (defined as Gleason score 7, or prostatic specific antigen (PSA) ≥ 10 ng/ml & < 20 ng/ml, or T-stage ≤ T2c)
  • Eligible for either radical prostatectomy (RP) or definitive radiation therapy (RT) (+/- short-term androgen deprivation therapy (ADT))
  • Age > 18 years
  • Biopsy specimen available

Exclusion Criteria:

  • Inability to acquire biopsy or prostatectomy tissue
  • History of prior PCa directed chemotherapy or pelvic irradiation (prior to study enrollment)
  • Documented distant metastatic disease or pelvic lymphadenopathy
  • Prior radical prostatectomy (RP) or cryosurgery for prostate cancer or bilateral orchiectomy
  • Targeted for active surveillance after diagnostic biopsy
  • Selecting ADT alone after diagnostic biopsy
  • On active surveillance for > 6 months after diagnosis

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UpFrontPSMA : A Randomised Phase 2 Study of Sequential 177Lu-PSMA617 and Docetaxel Versus Docetaxel in Metastatic Hormone-Naive Prostate Cancer


Condition: Metastatic Hormone Naive Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04343885

Sponsor: Peter MacCallum Cancer Centre, Australia

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • for study registration: 1. Patient has provided written informed consent 2. Male aged 18 years or older at screening 3. Prostate cancer diagnosed within 12 weeks of commencement of screening 4. Histologically or cytologically confirmed adenocarcinoma of the prostate without significant neuroendocrine differentiation or small cell histology OR metastatic disease typical of prostate cancer (i.e. involving bone or pelvic lymph nodes or para-aortic lymph nodes) with a rising serum PSA 5. Evidence of metastatic disease on CT and/or bone scan 6. PSA > 10ng/ml prior to commencement of medical ADT or surgical orchidectomy 7. Adequate haematological, renal and hepatic functions as defined by:
  • Absolute neutrophil count >1.5 x 109/L
  • Platelet count >100 x 109/L
  • Haemoglobin ≥ 90g/L (no red blood cell transfusion in 4 weeks prior to randomisation)
  • Creatinine Clearance ≥ 40mL/min (Cockcroft-Gault formula)
  • Total bilirubin < 1.5 x ULN (unless known or suspected Gilbert syndrome)
  • Aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 2.0 x ULN (or ≤ 5.0 x ULN in the presence of liver metastases) 8. Have a performance status of 0-2 on the ECOG Performance Scale (see Appendix 1) 9. Life expectancy greater than 6 months with treatment 10. Assessed by a medical oncologist as suitable for treatment with docetaxel 11. Patients must agree to use an adequate method of contraception 12. Willing and able to comply with all study requirements, including all treatments and required assessments including follow-up Exclusion Criteria for Registration: 1. Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer. The following exceptions are permitted:
  • Up to 4 weeks of ADT with luteinising hormone releasing hormone agonists or antagonists or orchiectomy ± concurrent anti-androgens are permitted prior to commencement of screening. At investigator discretion, patients may start ADT at commencement of protocol therapy
  • Up to one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 14 days prior to registration 2. Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression 3. Central nervous system metastases 4. Patients with Sjogren's syndrome 5. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator 6. Prior diagnosis of another cancer that was:
  • More than 3 years prior to current diagnosis with subsequent evidence of disease recurrence or clinical expectation of recurrence greater than 10%
  • Within 3 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma or adequately treated non-muscle invasive bladder cancer (Tis, Ta and low grade T1 tumours) Inclusion Criteria for Randomisation: 1. Significant PSMA avidity on 68Ga-PSMA PET/CT, defined after central review as a minimum uptake of SUVmax 15 at a site of disease 2. High-volume metastatic disease on 68Ga-PSMA PET/CT defined as visceral metastases or ≥ 4 bone metastases with ≥ 1 outside the vertebral column and pelvis (extra-axial skeleton) 3. Patient continues to meet all the inclusion criteria for registration Exclusion Criteria for Randomisation: 1. Major FDG-PET discordance defined as presence of FDG positive disease with minimal PSMA expression in multiple sites (>5) or in more than 50% of total disease volume 2. All the

Exclusion Criteria:

  • for Registration: 1. Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer. The following exceptions are permitted:
  • Up to 4 weeks of ADT with luteinising hormone releasing hormone agonists or antagonists or orchiectomy ± concurrent anti-androgens are permitted prior to commencement of screening. At investigator discretion, patients may start ADT at commencement of protocol therapy
  • Up to one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 14 days prior to registration 2. Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression 3. Central nervous system metastases 4. Patients with Sjogren's syndrome 5. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator 6. Prior diagnosis of another cancer that was:
  • More than 3 years prior to current diagnosis with subsequent evidence of disease recurrence or clinical expectation of recurrence greater than 10%
  • Within 3 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma or adequately treated non-muscle invasive bladder cancer (Tis, Ta and low grade T1 tumours) Inclusion Criteria for Randomisation: 1. Significant PSMA avidity on 68Ga-PSMA PET/CT, defined after central review as a minimum uptake of SUVmax 15 at a site of disease 2. High-volume metastatic disease on 68Ga-PSMA PET/CT defined as visceral metastases or ≥ 4 bone metastases with ≥ 1 outside the vertebral column and pelvis (extra-axial skeleton) 3. Patient continues to meet all the inclusion criteria for registration Exclusion Criteria for Randomisation: 1. Major FDG-PET discordance defined as presence of FDG positive disease with minimal PSMA expression in multiple sites (>5) or in more than 50% of total disease volume 2. All the exclusion criteria for registration continue to not apply

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