Prostate Cancer

Condition: Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04464226

Sponsor: Bayer

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Participants enrolled in any Bayer-sponsored darolutamide feeder study at the time of study closure or primary completion, who are currently receiving darolutamide and are experiencing clinical benefit from treatment.
• Participants who have not met any treatment discontinuation criteria in the feeder study protocol.
• Willingness to continue practicing acceptable methods of birth control during the study.

Exclusion Criteria:

• Participant is unable to comply with the requirements of the study.
• Negative benefit/ risk ratio as determined by the investigator.
• Meet any criteria for treatment discontinuation of the feeder study the participant is coming from.

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Condition: Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04597125

Sponsor: Bayer

Phase: Phase 4

Eligibility:

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

Inclusion Criteria:

• Participants who have histologically confirmed adenocarcinoma of the prostate.
• Participants with mCRPC progressing on/after one line of an approved NAH (eg. abiraterone, enzalutamide, apalutamide, or darolutamide, after being treated for at least 3 months) in an authorized prostate cancer indication.
• One prior taxane treatment regimen (at least 2 cycles) for metastatic prostate cancer (mHSPC and mCRPC) or refusal or ineligibility of such a regimen.
• Prostate cancer progression documented by PSA according to the Prostate Cancer Working Group 3 (PCWG3) criteria or radiological progression according to RECIST, version 1.1.
• At least 2 bone metastases on bone scan within 4 weeks prior to randomization with no current or history of lung, liver, other visceral, and / or brain metastasis.
• Symptomatic prostate cancer. A worst pain score (WPS) of at least 1 on the Brief Pain Inventory-Short Form (BPI-SF) Question #3 (worst pain in last 24 hours). This is to be assessed once during the Screening period.
• Maintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7 nmol/L). If the participant is being treated with luteinizing hormone releasing hormone (LHRH) agonists or antagonists (participant who has not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study.
• Participants must be on a BHA treatment, such as bisphosphonates or denosumab treatment unless such treatment is contraindicated or not recommended per investigator's judgement and inclusion is agreed to by the medical monitor.
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
• Life expectancy ≥ 6 months.
• Able to swallow abiraterone and prednisone/prednisolone or enzalutamide as whole tablets/capsules.
• Laboratory requirements:
• Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
• Platelet count ≥ 100 x 10^9/L
• Hemoglobin (Hb) ≥ 9.0 g/dL (90 g/L; 5.6 mmol/L)
• Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) (except for participants with documented Gilbert's disease)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
• Creatinine ≤ 1.5 x ULN or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m^2 as calculated using the Cockcroft-Gault equation
• International normalized ratio (INR) of prothrombin time (PT; PT-INR) and partial thromboplastin time (PTT) ≤ 1.5 times the ULN. Participants treated with warfarin or heparin will be allowed to participate in the study if no underlying abnormality in coagulation parameters exists per prior history; weekly evaluation of PT-INR / PTT will be required until stability is achieved (as defined by local standard of care and based on pre-study PT-INR / PTT values)
• Serum albumin > 30 g/L
• Serum potassium ≥ 3.5 mmol/L
• Capable of giving signed informed consent

Exclusion Criteria:

• Active infection or other medical condition that would make prednisone / prednisolone (corticosteroid) use contraindicated.
• Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone / prednisolone equivalent daily for more than 2 months.
• Pathological finding consistent with tumors with predominant neuroendocrine features or small cell carcinoma of the prostate.
• History of osteoporotic fracture
• History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations.
• History of or known brain metastasis.
• Malignant lymphadenopathy exceeding 3 cm in short-axis diameter.
• Other malignancy treated within the last 3 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
• Imminent spinal cord compression based on clinical findings and / or magnetic resonance imaging (MRI). Participants with history of spinal cord compression should have completely recovered.
• Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg). Participants with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
• Active or symptomatic viral hepatitis
• History of pituitary or adrenal dysfunction
• Any other serious illness or medical condition such as, but not limited to:
• Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 Grade 2
• Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II to IV heart disease or cardiac ejection fraction measurement of <50% at baseline
• Current clinical evidence of any uncontrolled cardiac arrhythmia
• Crohn's disease or ulcerative colitis
• Bone marrow dysplasia
• Moderate and severe hepatic impairment (Child-Pugh Classes B and C)
• Unmanageable fecal incontinence.
• Any condition, which in the opinion of the investigator would preclude participation in this trial (eg, history of seizure).
• Hypersensitivity to the active substances or to any excipients of radium-223 dichloride, or abiraterone acetate or enzalutamide.
• Prior therapeutic systemic radiation with any radiopharmaceutical medication for the treatment of prostate cancer, including but not limited to lutetium-177, strontium-89, samarium-153, iodine-131, rhenium-186, rhenium-188, or radium-223. Radiopharmaceutical compounds used for diagnosis purposes only are allowed.
• Prior hemibody external radiotherapy is excluded. Participants who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for Hb, ANC, and platelet count.
• Blood transfusion or erythropoietin stimulating agents 4 weeks prior to Screening and during the whole Screening period before randomization.
• Excessive intake of biotin above the recommended daily dose of 30 μg. Biotin is found in multivitamins, including prenatal multivitamins, biotin supplements, and dietary supplements for hair, skin, and nail growth at levels that may interfere with laboratory tests.
• Prior administration of an investigational therapeutic for CRPC.
• Previous (within the last 4 weeks of randomization) or concurrent participation in any interventional clinical study with investigational study drug administration.

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Condition: Non-metastatic Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05348876

Sponsor: Bayer

Phase: Phase 4

Eligibility:

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

Inclusion Criteria:

• Capable of giving signed informed consent.
• Participant must be male aged ≥ 18 years.
• Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.
• Castration resistance, demonstrated by:
• a minimum of 3 rising PSA values while the participant is on continuous ADT (started at least 4 weeks prior to the PSA measurement or, PSA measured at least 4 weeks after bilateral orchiectomy) and
• the interval between each PSA measurement must be ≥ 1 week, and
• the PSA value at screening must be ≥ 1.0 ng/mL (1.0 μg/L). To confirm this eligibility criterion, it is acceptable for 2 out of the 3 PSA measurements to be taken during the 28-day screening period (after participant has signed consent), provided the measurements are ≥ 1 week apart. In this case, the last PSA value should be recorded as the screening value.
• Castrate level of serum testosterone (< 1.7 nmol/L [50 ng/dL]) on gonadotropin releasing hormone (GnRH) agonist or antagonist therapy or after bilateral orchiectomy. Participants who have not undergone bilateral orchiectomy must continue GnRH therapy during the study.
• PSA doubling time (PSADT) of ≤ 10 months.
• Eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1.
• Estimated glomerular filtration rate (eGFR) > 15 mL/min/1.73 m^2.
• Blood counts at screening: hemoglobin ≥ 9.0 g/dL, absolute neutrophil count ≥ 1500/μL (1.5 × 109/L), platelet count ≥ 100,000/μL (100 ×109/L) (participant must not have received any growth factor or blood transfusion within 7 days of the hematology laboratory obtained at screening).
• Screening values of serum alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 × upper limit of normal (ULN), total bilirubin (TBL) ≤ 1.5 × ULN (except participants with a diagnosis of Gilbert's disease), creatinine ≤ 2.0 × ULN.
• Sexually active participants, unless surgically sterile, must agree to use a male condom plus partner use of a contraceptive method with a failure rate of <1% per year, and refrain from sperm donation during the study treatment and for 1 week after the last dose of study treatment. Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

• History of metastatic disease at any time or presence of detectable metastases by investigator assessment within 42 days prior to start of study treatment based on standard medical imaging, i.e., computed tomography/ magnetic resonance imaging (CT/MRI) and bone scan. (Lesions seen on prostate-specific membrane antigen /positron emission tomography (PSMA/PET) scan that are not detected on standard imaging do not exclude participation.) Presence of pelvic lymph nodes < 1.5 cm in short axis below the aortic bifurcation is allowed.
• Symptomatic local-regional disease that requires medical intervention including moderate/severe urinary obstruction or hydronephrosis due to prostate cancer.
• Acute toxicities of prior treatments and procedures not resolved to common terminology criteria for adverse events (CTCAE) v.5.0 grade ≤ 1 or baseline before first dose of study treatment.
• Severe or uncontrolled concurrent disease, infection, or co-morbidity that, in the opinion of the investigator, would make the participant inappropriate for enrollment.
• Known hypersensitivity to the study treatment or any of its ingredients.
• Major surgery within 28 days before first dose of study treatment.
• Any of the following within 6 months before first dose of study treatment: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association Class III or IV.
• Uncontrolled hypertension as indicated by a systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 100 mmHg at screening despite medical management. Participants with hypertension can enroll provided BP is stable and controlled by anti-hypertensive treatment.
• End-stage renal disease (eGFR < 15 mL/min/1.73 m^2).
• Prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed ≥ 5 years ago and from which the participant has been disease-free.
• Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.
• Unstable active viral hepatitis with a need for treatment.
• Known human immunodeficiency virus (HIV) infection with any of the following (Note: HIV testing is not required unless mandated by local authority):
• CD4+ T-cell (CD4+) count of less than 350 cells/μL
• History of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months
• On established antiretroviral therapy for less than 4 weeks
• Presenting with a viral load of more than 400 copies/mL prior to enrollment
• On antiretroviral therapy or prophylactic antimicrobials that are expected to cause significant drug-drug interactions or overlapping toxicities with study treatment and cannot be changed to alternative agents.
• Any condition that, in the opinion of the investigator, would impair the participants' ability to comply with the study procedures or study treatment (e.g., unable to swallow study treatment).
• Unwilling or unable to comply with all protocol-required visits and assessments or comply with study requirements.
• Prior treatment with:
• Second-generation androgen receptor (AR) inhibitors (such as enzalutamide, apalutamide, darolutamide, proxalutamide, etc)
• Other investigational AR inhibitors
• Cytochrome P450 (CYP17) enzyme inhibitors (such as oral ketoconazole, abiraterone acetate, TAK-700, etc).
• Use of first-generation AR inhibitors (bicalutamide, flutamide, nilutamide, cyproterone acetate) within 28 days before first dose of study treatment.
• Use of estrogens or 5-α reductase inhibitors (finasteride, dutasteride) within 28 days before first dose of study treatment.
• Prior chemotherapy or immunotherapy for prostate cancer, except adjuvant/neoadjuvant treatment completed > 2 years before first dose of study treatment.
• Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days before first dose of study treatment.
• Radiation therapy (external beam radiation therapy, brachytherapy, or radiopharmaceuticals) within 12 weeks before first dose of study treatment.
• Treatment with an osteoclast-targeted therapy (bisphosphonate or denosumab) to prevent skeletal-related events within 4 weeks before first dose of study treatment. Participants receiving osteoclast-targeted therapy to prevent bone loss at a dose and schedule indicated for osteoporosis may continue treatment at the same dose and schedule.
• Treatment with any investigational drug within 28 days before first dose of study treatment.

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05171387

Sponsor: Bayer

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

• Participant must be ≥18 years of age inclusive, at the time of signing the informed consent.
• Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.
• Castration resistance, demonstrated by:
• a minimum of 3 rising PSA values while the participant is on continuous ADT (started at least 4 weeks prior to the PSA measurement or, PSA measured at least 4 weeks after bilateral orchiectomy) and
• the interval between each PSA measurement must be ≥1 week, and
• the PSA value at screening must be ≥1 ng/mL (1 μg/L). (To confirm this eligibility criterion, it is acceptable for 2 out of the 3 PSA measurements to be taken during the 28-day screening period (after participant has signed consent), provided the measurements are ≥1 week apart. In this case, the last PSA value should be recorded as the screening value.)
• Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dl]) on GnRH agonist or antagonist therapy or after bilateral orchiectomy. Participants who have not undergone bilateral orchiectomy must continue GnRH therapy during the study.
• Prostate-specific antigen doubling time (PSADT) of ≤ 10 months.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Blood counts at screening: hemoglobin ≥ 9.0 g/dl, absolute neutrophil count ≥ 1500/μl (1.5x109/l), platelet count ≥ 100,000/μl (100x109/l ) (participant must not have received any growth factor or blood transfusion within 7 days of the hematology laboratory obtained at screening).
• Screening values of serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN), total bilirubin (TBL) ≤1.5 x ULN (except participants with a diagnosis of Gilbert's disease), creatinine ≤2.0 x ULN.
• Male: Sexually active participants, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 1 week after the end of the study treatment. If the participant is engaged in sexual activity with a woman of childbearing potential (WOCBP), highly effective contraception should be used during and for 1 week after completion of treatment with darolutamide to prevent pregnancy.Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

• History of metastatic disease at any time or presence of detectable metastases assessed by the investigator within 42 days prior to start of study treatment. Presence of pelvic lymph nodes < 1.5 cm in short axis below the aortic bifurcation is allowed.
• Symptomatic local-regional disease that requires medical intervention including moderate/severe urinary obstruction or hydronephrosis due to prostate cancer.
• Acute toxicities of prior treatments and procedures not resolved to ≤ CTCAE v5.0 grade 1 or baseline before treatment assignment.
• Severe or uncontrolled concurrent disease, infection or co-morbidity that, in the opinion of the investigator, would make the participant inappropriate for enrollment.
• Known hypersensitivity to the study treatment or any of its ingredients.
• Major surgery within 28 days before treatment assignment.
• Any of the following within 6 months before treatment assignment: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.
• Uncontrolled hypertension as indicated by a systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite medical management at screening.
• Prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e. pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed ≥ 5 years ago and from which the participant has been disease-free.
• Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.
• Active viral hepatitis, known human immunodeficiency virus (HIV) infection with detectable viral load, or chronic liver disease with a need of treatment.
• Any condition that in the opinion of the investigator would impair the participants' ability to comply with the study procedures.
• Unable to swallow study medications and/or comply with study requirements.
• Prior treatment with:
• second-generation AR inhibitors such as enzalutamide, apalutamide, darolutamide, other investigational AR inhibitors
• CYP17 enzyme inhibitor such as abiraterone acetate, TAK-700
• Oral ketoconazole longer than for 28 days (continuous use).
• Use of estrogens or 5-α reductase inhibitors (finasteride, dutasteride) within 28 days before start of study treatment (Day 1) or first-generation AR inhibitors (bicalutamide, flutamide, nilutamide, cyproterone acetate) within 28 days before start of study treatment (Day 1).
• Prior chemotherapy or immunotherapy for prostate cancer, except adjuvant/neoadjuvant treatment completed > 2 years before teatment assignment.
• Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days before start of treatment assignment.
• Radiation therapy (external beam radiation therapy [EBRT], brachytherapy, or radiopharmaceuticals) within 12 weeks before randomization.
• Treatment with an osteoclast-targeted therapy (bisphosphonate or denosumab) to prevent skeletal-related events within 12 weeks before randomization. Participants receiving osteoclast-targeted therapy to prevent bone loss at a dose and schedule indicated for osteoporosis may continue treatment at the same dose and schedule.
• Treatment with any investigational drug within 28 days before start of study treament (Day 1).
• Treatment with any investigational drug, or Traditional Chinese Medication (TCM) that is approved as a cancer treatment, within 28 days before start of study treatment (Day 1).

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Condition: Metastatic Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06052306

Sponsor: Bayer

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

• mCRPC with pathological confirmation of adenocarcinoma without small-cell or neuroendocrine features.
• Previous treatment with at least 1 Novel androgen axis drug (NAAD) (e.g., enzalutamide, apalutamide, darolutamide and/or abiraterone).
• Prior orchiectomy and/or ongoing androgen deprivation therapy and a castrate level of serum testosterone (<50 ng/dL or <1.7 nmol/L).
• Prior taxane treatment:
• Dose Escalation: Participants must either have had prior treatment with at least 1 but no more than 2 taxane regimens, or been deemed ineligible for or refused taxane therapy on consultation with their physician
• Dose Expansion Group A: Participants must have had prior treatment with at least 1 but no more than 2 taxane regimens, in the castration-resistant setting
• Dose Expansion Group B: Participants must not have received taxane therapy since becoming castration-resistant
• Dose Expansion Group C: Participants must either have had prior treatment with at least 1 but no more than 2 taxane regimens, or been deemed ineligible for or refused taxane therapy on consultation with their physician
• Prior treatment with 177Lu-PSMA is required for participants in Dose Expansion Group C only.
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
• Adequate bone marrow, hepatic, and renal function, as assessed by the following laboratory requirements within 28 days before start of study treatment:
• Hemoglobin ≥9.0 g/dL
• Absolute neutrophil count (ANC) ≥1500/mm^3
• Platelet count ≥100,000/mm^3
• Total bilirubin ≤1.5 x the Upper limit of normal (ULN), except if confirmed history of Gilbert's disease
• Alanine transaminase (ALT) and Aspartate transaminase (AST) ˂2.5 x ULN (≤5 x ULN for participants with liver involvement)
• Participants on a stable dose of anticoagulation therapy are allowed to participate if they have no sign of bleeding or clotting, and Prothrombin time international normalized ratio (PT/INR) and activated partial thromboplastin time (aPTT) test results are acceptable at the Investigator's discretion
• Estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m^2, according to the Modified Diet in Renal Disease (MDRD) abbreviated formula and creatinine clearance (CrCl) >60 mL/min based on Cockcroft-Gault formula
• Participants must have at least one Prostate-specific membrane antigen (PSMA)-positive distant metastatic lesion on the screening PSMA PET/CT scan using the study-designated PSMA PET tracers, as determined by the site Investigator. For eligibility purposes, a PSMA-positive lesion must have activity greater than the liver by visual assessment of the screening PSMA PET/CT. A PSMA-positive metastatic lesion should not correspond to a normal tissue structure or benign lesion.

Exclusion Criteria:

• Participants who have any of the following tumor lesions which are PSMA negative AND meet the size criteria below are excluded as determined by the site investigator. A PSMA-negative lesion for eligibility purposes must have activity equal to or less than the liver by visual assessment of the screening PSMA PET/CT scan using the study-designated PSMA PET/CT tracers. A PSMA-negative metastatic lesion should not correspond to a normal tissue structure or benign lesion.
• a. Any single or multiple lymph node(s) ≥2.5cm in the short axis.
• b. Any solid organ metastasis (e.g., lung, liver, adrenal glands, etc.) that is ≥1 cm in the short axis.
• c. Any bone metastasis with a soft tissue component ≥ 1cm in short axis with the soft tissue component being PSMA-negative. PSMA-negative osseous metastases without a soft tissue component do not exclude a participant.
• d. Predominantly necrotic lesions with greater than 1cm of enhancing tissue on contrast-enhanced Computer tomography / magnetic resonance imaging (CT/MRI).
• Prior systemic anticancer therapy including chemotherapy, NAAD, biologic therapy, immunotherapy, or investigational therapies within 4 weeks of the start of study treatment, except luteinizing hormone-releasing hormone (LHRH) or gonadotropin-releasing hormone (GnRH). Start of study treatment is allowed in shorter timeframes if 5 half-lives of the prior drug(s) have elapsed.
• Prior radiopharmaceutical treatment using 225Ac.
• Other prior radiopharmaceutical treatments:
• Dose escalation and Dose expansion Groups A and B: Prior treatment with a radiopharmaceutical is prohibited.
• Dose expansion Group C: Prior treatment with a radiopharmaceutical is prohibited with the following exceptions: Prior treatment with radium-223 dichloride more than 3 months before the start of study treatment is permitted; and prior treatment with 177Lu PSMA more than 6 weeks before the start of study treatment is required.
• Prior definitive therapy (radiotherapy or surgery) completed less than 6 weeks before the start of study treatment. Note that palliative radiotherapy completed less than 6 weeks before the start of study treatment will be allowed if: (i) no more than 10% of the participants' bone marrow is irradiated, (ii) it does not encompass all potential target/measurable lesions for participants in dose expansion.
• Toxic effects of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 from prior anticancer therapy not yet stabilized or where significant post-treatment toxicities have been observed. Chronic toxic effects of CTCAE Grade ≤2 from prior anticancer therapy where no further resolution is expected do not require exclusion with agreement between the Investigator and Sponsor (e.g., chemotherapy-induced neuropathy, fatigue, alopecia, anorexia, etc.).

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Condition: Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT06010914

Sponsor: Bayer

Phase:

Eligibility:

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

Inclusion Criteria:

• Men over the age of 18 years
• Histologically or cytologically confirmed adenocarcinoma prostate cancer
• Metastatic disease confirmed either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan
• Patients diagnosed with mHSPC by the investigator under routine clinical practice, and must be judged appropriate for/decided to be treated with darolutamide plus ADT and docetaxel therapy by the investigator under routine clinical practice
• ADT (GnRH agonist/antagonist or orchiectomy) before or simultaneous treatment with darolutamide
• Signed informed consent

Exclusion Criteria:

• Participation in an investigational program with interventions outside of routine clinical practice
• Contraindications according to the local marketing authorization
• Previous treatment with darolutamide

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04396808

Sponsor: University of Michigan Rogel Cancer Center

Eligibility:

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

Inclusion Criteria:

• Prostate cancer patients who have undergone diagnostic prostate biopsy in the past 9 months.
• Prostate biopsy tumor tissue (FFPR block) available for processing
• Age 18 years or older
• PSA <20 ng/ml
• Grade Group (GG) 1 cancer with > 2 biopsy cores involved with cancer OR GG2 cancer
• Ability to understand and the willingness to sign a written informed consent. A subject's legally acceptable representative may sign the consent form.

Exclusion Criteria:

• Clinical (on digital rectal exam) or radiographic evidence (if MRI performed) of T3 disease
• Nodal or metastatic prostate cancer (if staging imaging performed)
• Prior prostate cancer treatment, including prostatectomy, radiation therapy, or hormone therapy.
• Prior prostate gene expression classier testing

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Condition: Prostatic Neoplasms, Castration-Resistant

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04868604

Sponsor: Clarity Pharmaceuticals Ltd

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

• Signed informed consent;
• ≥18 years of age;
• Eastern Cooperative Oncology Group performance status of 0 to 2;
• Life expectancy >6 months;
• Histological, pathological, and/or cytological confirmation of Prostate cancer (PCa);
• Positive 64Cu-SAR-bisPSMA PET/CT scan, where 64Cu-SAR-bisPSMA uptake (standardized uptake value [SUV] max) of at least 1 known lesion is higher than that of the liver on the 1 hour positron emission tomography (PET)/computed tomography (CT) scan;
• Castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L);
• Have progressive metastatic castration-resistant prostate cancer (mCRPC) despite prior androgen deprivation therapy and at least either enzalutamide and/or abiraterone (or other such androgen receptor pathway inhibitors). Documented progressive mCRPC will be based on at least 1 of the following criteria: 1. Serum/plasma prostate specific antigen (PSA) progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal value for study enrollment is 2.0 ng/mL; 2. Soft-tissue progression defined as a ≥20% increase in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since the last treatment directed at the metastatic cancer has started (not including hormonal therapy) or the appearance of 1 or more new lesions; 3. Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan.
• ≥1 metastatic lesion that is present at screening CT, magnetic resonance imaging (MRI), or bone scan imaging obtained ≤28 days prior to enrollment into the study;
• Participants must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (prior chemotherapy, radiation, immunotherapy, etc.);
• Participants must have adequate organ function:
• Bone marrow reserve:
• White blood cell (WBC) count ≥2.5 x 109/L (2.5 x 109/L is equivalent to 2.5 x 103/μL and 2.5 x K/μL and 2.5 x 103/cc and 2500/μL) OR
• Absolute neutrophil count (ANC) ≥1.5 x 109 /L (1.5 x 109 /L is equivalent to 1.5 x 103 /μL and 1.5 x K/μL and 1.5 x 103 /cc and 1500/μL);
• Platelets ≥100 x 109 /L (100 x 109 /L is equivalent to 100 x 103 /μL and 100 x K/μL and 100 x 103 /cc and 100,000/μL);
• Hemoglobin ≥9 g/dL (5.59 mmol/L);
• Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3 x ULN is permitted;
• Alanine aminotransferase or aspartate aminotransferase ≤3.0 x ULN OR ≤5.0 x ULN for participants with liver metastases;
• Creatinine clearance or estimated glomerular filtration rate ≥50 mL/min
• For participants who are human immunodeficiency virus infected: Participant must be healthy and have a low risk of Acquired Immune Deficiency Syndrome related outcomes in the opinion of the Investigator;
• For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection.

Exclusion Criteria:

• Major surgery within 12 weeks prior to enrollment into the study;
• Brain metastasis;
• Histologic diagnosis of small cell or neuroendocrine prostate cancer;
• Prior history of leukemia or Myelodysplastic Syndrome;
• Diagnosis of Deep Vein Thrombosis or Pulmonary Embolism within 4 weeks prior to enrollment into the study;
• Unmanageable urinary tract obstruction;
• Evidence of progressive lesion(s) on MRI and/or CT (according to Response Evaluation Criteria in Solid Tumors V1.1) that is prostate-specific membrane antigen (PSMA) negative on the 1 hour 64Cu-SAR-bisPSMA PET/CT scan as determined at screening;
• Previous treatment with a systemic radionuclide, including 177Lu, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Actinium-225, Iodine-131 within 6 months or in case of Radium-223 within 3 months of treatment initiation (Day 0) without prior approval of the medical monitor;
• Previous treatment with any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 4 weeks prior to treatment on study with the exception of Luteinizing Hormone Releasing Hormone, any other androgen deprivation therapy (ADT) (if ADT is discontinued prior to enrolment, 14 days must elapse after abiraterone discontinuation and 28 days after enzalutamide before participant can be enrolled) or low dose corticosteroids;
• Previous treatment with any investigational agents within 4 weeks prior enrollment into the study;
• Known hypersensitivity to the components of the investigational products or its analogues;
• Transfusion for the sole purpose of making a participant eligible for study inclusion;
• Spinal metastasis with symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression;
• Concurrent serious medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation;
• Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer, superficial bladder cancer;
• Any condition or personal situation that would pose an unacceptable radiation safety risk (as per institution guidelines, state and/or national regulations) to the participant or carer at the time of release following the completion of therapy (e.g. uncontrolled urinary incontinence, high dependency care);
• Participants in whom it is known that external beam radiation therapy is scheduled after enrollment into the study.

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04422132

Sponsor: Weill Medical College of Cornell University

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum 90 Years
• Gender: Male

Inclusion Criteria:

• Men aged 18 and older with histologically confirmed prostate cancer after prostatectomy with detectable PSA. PSA does not need to be detectable for men with pathologically node positive disease.
• KPS >=70
• Patient with no evidence of distant metastatic disease on PET/CT/MRI or bone scan < 9 months prior to enrollment. Patients with positive pelvic lymph nodes are eligible.
• Ability to receive MRI-guided radiotherapy.
• Equivocal evidence of metastatic disease outside the pelvis on standard imaging requires documented negative biopsy.
• Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.

Exclusion Criteria:

• Prior history of receiving pelvic radiotherapy.
• Patient with inflammatory bowel disease.
• Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of ultra-hypofractionated radiotherapy.
• History of bladder neck or urethral stricture.

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05345444

Sponsor: Weill Medical College of Cornell University

Eligibility:

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

Inclusion Criteria:

• 1. Men aged ≥ 18 2. ECOG 0
• 1 3. Histologically confirmed intermediate risk prostate cancer per NCCN guidelines. 4. Focal grade group 2 or 3 (GS 3+4 or GS 4 + 3) cancer in MRI target 5. Gland size < 80 cc 6. Ability to undergo IRE 7. Ability to receive MRI-guided radiotherapy. 8. Ability to complete the HRQOL assessment surveys 9. Willingness to undergo 12 month follow up biopsy

Exclusion Criteria:

1. Prior history of focal therapy.
2. Prior history of receiving pelvic radiotherapy.
3. Patient with metastatic prostate cancer.
4. Patient with history of inflammatory bowel disease.
5. Inability to undergo general anesthesia
6. Inability to be placed within the lithotomy position for a transperineal approach to both biopsy and treatment.
7. Patients with a prior or concurrent disease whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ or low-grade non-muscle invasive bladder cancer) who has been disease-free for less than 3 years must contact the Principal Investigator.
8. History of bladder neck or urethral stricture.

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Condition: Prostate Adenocarcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05050084

Sponsor: NRG Oncology

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

• Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of the prostate within 270 days prior to registration
• Unfavorable intermediate risk prostate cancer, defined as having ALL the following bulleted criteria:
• Has at least one intermediate risk factor (IRF):
• PSA 10-20 ng/mL
• Clinical stage T2b-c (digital rectal examination [DRE] and/or imaging) by American Joint Committee on Cancer (AJCC) 8th edition
• Gleason score 7 (Gleason 3+4 or 4+3 [ International Society of Urological Pathology (ISUP) Grade Group 2-3])
• Has ONE or more of the following 'unfavorable' intermediate-risk designators:
• > 1 immature reticulocyte fraction (IRF)
• Gleason 4+3=7 (ISUP Grade Group 3)
• >= 50% of biopsy cores positive
• Biopsies may include 'sextant' sampling of right/left regions of the prostate, often labeled base, mid-gland and apex. All such 'sextant' biopsy cores should be counted. Men may also undergo 'targeted' sampling of prostate lesions (guided by MRI, ultrasound or other approaches). A targeted lesion that is biopsied more than once and demonstrates cancer (regardless of number of targeted cores involved) should count as a single additional positive core sampled and positive. In cases of uncertainty, count the biopsy sampling as sextant core(s)
• Absence of high-risk features
• Appropriate stage for study entry based on the following diagnostic workup:
• History/physical examination within 120 days prior to registration;
• Negative bone imaging (M0) within 120 days prior to registration; Note: Tc-99m bone scan or sodium fluoride (NaF) positron emission tomography (PET) are allowed. Equivocal bone scan findings are allowed if plain films X-ray, computed tomography (CT) or magnetic resonance imaging (MRI) are negative for metastasis at the concerned site(s). While a negative fluciclovine, choline, or prostate specific membrane antigen (PSMA) PET may be counted as acceptable substitute for bone imaging, any suspicious findings must be confirmed and correlated with conventional imaging (Tc-99m bone scan, NaF PET, CT, X-ray, or MRI) to determine eligibility based on the latter modalities (e.g. M0 based on conventional imaging modalities)
• Clinically negative lymph nodes (N0) as established by conventional imaging (pelvic +/- abdominal CT or MR), within 120 days prior to registration. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are =< 1.0 cm in short axis and/or if biopsy is negative. Note: While a negative fluciclovine, choline, or prostate specific membrane antigen (PSMA) PET may be counted as acceptable substitute for pelvic imaging, any suspicious findings must be confirmed by conventional imaging (CT, MRI or biopsy). If the findings do not meet pathological criteria based on the latter modalities (e.g. node =< 10 mm in short axis, negative biopsy), the patient will still be eligible
• Age >= 18
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 120 days prior to registration
• Non-castrate testosterone level (> 50 ng/dL) within 120 days prior to registration
• Absolute neutrophil >= 1,000 cells/mm^3 (within 120 days prior to registration)
• Hemoglobin >= 8.0 g/dL, independent of transfusion and/or growth factors (within 120 days prior to registration)
• Platelet count >= 100,000 cells/mm^3 independent of transfusion and/or growth factors (within 120 days prior to registration)
• Creatinine clearance (CrCl) >= 30 mL/min estimated by Cockcroft-Gault equation (within 120 days prior to registration)
• For African American patients specifically whose renal function is not considered adequate by the formula above, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) should be used for calculating the related estimated glomerular filtration rate (GFR) with a correction factor for African American race creatinine clearance for trial eligibility, where GFR >= 30 mL/min/1.73m^2 will be considered adequate
• Total bilirubin: 1.5 =< institutional upper limit of normal (ULN) (within 120 days prior to registration) (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin. If direct bilirubin is less than or equal to 1.5 x ULN, subject is eligible)
• Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]): =< 2.5 x institutional ULN (within 120 days prior to registration)
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial; Note: HIV testing is not required for eligibility for this protocol
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
• Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)
• For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
• Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy
• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

Exclusion Criteria:

• Previous radical surgery (prostatectomy) or any form of curative-intent ablation whether focal or whole-gland (e.g., cryosurgery, high intensity focused ultrasound [HIFU], laser thermal ablation, etc.) for prostate cancer
• Definitive clinical or radiologic evidence of metastatic disease (M1)
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. History of or current diagnosis of hematologic malignancy is not allowed
• Prior radiotherapy to the prostate/pelvis region that would result in overlap of radiation therapy fields
• Previous bilateral orchiectomy
• Previous hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate). ADT started prior to study registration is not allowed
• Prior use of 5-alpha-reductase inhibitors is allowed, however, it must be stopped prior to enrollment on the study with at least a 30 day washout period before baseline study PSA measure and registration
• Active testosterone replacement therapy; any replacement therapy must be stopped at least 30 days prior to registration
• Severe, active co-morbidity defined as follows:
• Current severe or unstable angina;
• New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)
• History of any condition that in the opinion of the investigator, would preclude participation in this study
• Inability to swallow oral pills
• High risk features, which includes any of the following:
• Gleason 8-10 [ISUP Grade Group 4-5]
• PSA > 20
• cT3-4 by digital exam OR gross extra-prostatic extension on imaging [indeterminate MRI evidence will not count and the patient will be eligible]

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04984343

Sponsor: Weill Medical College of Cornell University

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum 90 Years
• Gender: Male

Inclusion Criteria:

• Men aged >=18 with histologically confirmed low or intermediate risk prostate cancer per NCCN guidelines.
• ECOG 0
• 1
• IPSS < 18
• Ability to receive MRI-guided radiotherapy.
• Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.
• Patients with a prior or concurrent disease whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ or low-grade non-muscle invasive bladder cancer) who has been disease-free for less than 3 years must contact the Principal Investigator.

Exclusion Criteria:

• Prior history of receiving pelvic radiotherapy.
• Patient with history of inflammatory bowel disease.
• MRI Prostate Volume > 80 cc
• MRI Stage > T3a
• Unilateral or bilateral hip replacements.
• History of bladder neck or urethral stricture.
• TURP < 8 weeks prior to radiotherapy
• Metastatic (pelvic nodal or distant) disease on CT, Bone, Fluciclovine, and/or PSMA PET scan

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Condition: Biochemically Recurrent Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05794906

Sponsor: Bayer

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

• Capable of giving signed informed consent as described which includes compliance with the requirements, restrictions listed in the informed consent form (ICF), and in this protocol.
• Male ≥18 years of age at the time of signing the informed consent.
• Histologically or cytologically confirmed adenocarcinoma of prostate.
• Prostate cancer initially treated by: radical prostatectomy (RP) followed by adjuvant radiotherapy (ART), or salvage radiotherapy (SRT), or RP in participants who are unfit (or refused) for ART or SRT, or primary radiotherapy (RT).
• High-risk biochemical recurrence (BCR), defined as Prostate-specific antigen doubling time (PSADT) <12 months calculated using the formula provided by the Sponsor, and PSA ≥0.2 ng/mL after ART or SRT post RP or after RP in participants who are unfit for ART or SRT (local or central values accepted), or PSA ≥2 ng/mL above the nadir after primary RT only (local or central values accepted).
• Participants must undergo prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) within the 42-day Screening period using either 18F-DCFPyL (piflufolastat F 18) or 68Ga-PSMA-11 which will be assessed by blinded independent central review (BICR) to identify at least one PSMA PET/CT lesion of prostate cancer.
• Serum testosterone ≥150 ng/dL (5.2 nmol/L) (local or central values accepted).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Blood counts at screening: Hemoglobin ≥9.0 g/dL (participant must not have received blood transfusion within 7 days prior to sample being taken); Absolute neutrophil count (ANC) ≥1.5x10^9/L (participant must not have received any growth factor within 4 weeks prior to sample being taken); Platelet count ≥100x10^9/L.
• Screening values of: Alanine aminotransferase (ALT) ≤1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) ≤1.5 x ULN; Total bilirubin (TBL) ≤1.5 ULN, (except participants with a diagnosis of Gilbert's disease); Estimated glomerular filtration rate (eGFR) >40 ml/min/1.73 m^2 calculated by the CKD-EPI formula.
• Sexually active male participants must agree to use contraception as detailed in the protocol during the Treatment period and for at least 1 week after the last dose of study treatment, and refrain from donating sperm during this period.

Exclusion Criteria:

• Pathological finding consistent with small cell, ductal or ≥50 % component of neuroendocrine carcinoma of the prostate.
• History of bilateral orchiectomy.
• Metastases or recurrent /new malignant lesions in prostate gland/bed seminal vesicles, lymph nodes below the CIA bifurcation on conventional imaging (CI) as assessed by BICR during screening.
• Brain metastasis on PSMA PET /CT by BICR at screening.
• High-risk BCR after primary radiotherapy with new loco-regional lesions on screening PSMA PET/CT who are eligible for curative salvage prostatectomy. Note: Participants treated with curative salvage prostatectomy after primary RT who meet the PSA criteria (inclusion criteria 5) may be considered for the study.
• Prior treatment with second generation (e.g. enzalutamide, apalutamide) androgen receptor inhibitors (ARIs) and CYP 17 inhibitors (e.g., abiraterone) within 18 months prior to signing of the ICF.
• Prior treatments with PSMA-radiotherapeutics within 12 months prior to randomization.
• Prior radiotherapy (including image-guided radiotherapy) as primary, adjuvant or salvage treatment completed within 8 weeks prior to signing of the ICF.
• Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years.
• History of pelvic radiotherapy for other malignancy.

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Condition: Metastatic Malignant Neoplasm in the Bone, Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04513717

Sponsor: NRG Oncology

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

• PRIOR TO STEP 1 REGISTRATION
• Pathologically proven diagnosis of adenocarcinoma of prostate cancer within 180 days prior to registration
• High-risk disease defined as having at least one or more of the following:
• PSA > 20 ng/mL prior to starting ADT Note: Patients receiving a 5-alpha reductase inhibitor (ex. finasteride) at the time of enrollment are eligible. The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors and the medication should be discontinued prior to randomization but a washout period is not required.
• cT3a-T4 by digital exam or imaging (American Joint Committee on Cancer [AJCC] 8th edition [Ed.])
• Gleason score of 8-10
• Node positive by conventional imaging with a short axis of at least 1.0 cm
• Appropriate stage for study entry based on the following diagnostic workup:
• History/physical examination within 120 days prior to registration;
• Bone imaging within 120 days prior to registration;
• Note: To be eligible, patient must have no definitive evidence of bone metastases (M0) on bone scan or sodium fluoride (NaF) PET within 120 days prior to registration (negative NaF PET/CT or negative Axumin or choline PET or negative fluciclovine, choline or prostate-specific membrane antigen (PSMA) PET within 120 days prior to registration is an acceptable substitute if they have been performed). Patients who have bone metastases established only fluciclovine, choline, or PSMA PET but not definitive on bone scan or NaF PET will still be eligible
• CT or MRI of the pelvis within 120 days prior to registration (negative fluciclovine, choline, or PSMA PET within 120 days prior to registration is an acceptable substitute). As with bone staging, nodal staging for trial purposes will be based off of conventional imaging findings only
• Patients with confirmed N1 metastases on conventional imaging (CT/MRI) as defined by ≥10 mm on short axis are eligible but will be automatically assigned to the intensification study. Patients who are positive by fluciclovine, choline, or PSMA PET (i.e. N1), but whose nodes do not meet traditional size criteria for positivity (i.e. they measure ≥ 10 mm on either the CT or MRI portion of the PET or on a dedicated CT or MRI) will not be considered N1 for the trial and will not automatically be assigned to the intensification study
• Age ≥ 18
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 120 days prior to registration
• Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors (within 120 days prior to registration)
• Platelet count ≥ -100 x 10^3/uL independent of transfusion and/or growth factors (within 120 days prior to registration)
• Creatinine clearance (CrCl) ≥ 30 mL/min estimated by Cockcroft-Gault equation (within 120 days prior to registration)
• For Black patients whose renal function is not considered adequate by Cockcroft-Gault formula, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) may be used for calculating creatinine clearance for trial eligibility
• Either a CrCl ≥ 30 ml/min or calculated glomerular filtration rate (GFR) ≥ 30 will make a patient eligible
• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 120 days prior to registration)
• 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 is eligible
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional ULN (within 120 days prior to registration)
• Serum albumin ≥ 3.0 g/dL (within 120 days prior to registration)
• The patient must agree 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 agree 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
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial and have a CD4 count ≥ 200 cells/microliter within 60 days prior to registration. Note: HIV testing is not required for eligibility for this protocol. Of note, for patients with HIV in the intensification trial randomized to apalutamide, highly active antiretroviral therapy (HAART) may need to be adjusted to medications that do not interact with apalutamide
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable after or on suppressive therapy within 60 days prior to registration, if indicated. Note: HBV viral testing is not required for eligibility for this protocol
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ or low-grade non-muscle invasive bladder cancer) who has been disease-free for less than 3 years must contact the principal investigator
• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
• PRIOR TO STEP 2 RANDOMIZATION
• Confirmation of Decipher score
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load within 60 days prior. Note: Apalutamide may interfere with HCV drugs. Patients on HCV medications should alert their infectious diseases physician if they get randomized to apalutamide due to the possibility that apalutamide can affect the bioavailability of some HCV medications. HCV viral testing is not required for eligibility for this protocol
• For patients entering the Intensification Cohort ONLY: Patients must discontinue or substitute concomitant medications known to lower the seizure threshold at least 30 days prior to Step 2 randomization

Exclusion Criteria:

• PRIOR TO STEP 1 REGISTRATION:
• Definitive radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI)
• Prior systemic chemotherapy within ≤ 3 years prior to registration; note that prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration
• Prior radical prostatectomy
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• Current use of 5-alpha reductase inhibitor. NOTE: If the alpha reductase inhibitor is stopped prior to randomization the patient is eligible
• History of any of the following:
• Seizure disorder
• Current severe or unstable angina
• New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)
• History of any condition that in the opinion of the investigator, would preclude participation in this study
• Evidence of any of the following at registration:
• Active uncontrolled infection requiring IV antibiotics
• Baseline severe hepatic impairment (Child Pugh Class C)
• Inability to swallow oral pills
• Any current condition that in the opinion of the investigator, would preclude participation in this study
• Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone-releasing hormone [LHRH] agonist and oral anti-androgen) is ≤ 60 days prior to registration; Please note: baseline PSA must be obtained prior to the start of any ADT
• PRIOR TO STEP 2 RANDOMIZATION:
• Evidence of known gastrointestinal disorder affecting absorption of oral medications at registration
• For patients entering the Intensification Cohort ONLY: Presence of uncontrolled hypertension (persistent systolic blood pressure [BP] ≥ 160 mmHg or diastolic BP ≥ 100 mmHg). Subjects with a history of hypertension are allowed, provided that BP is controlled to within these limits by anti-hypertensive treatment

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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 6 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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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.

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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; and
• Presence of ≥ 2 metastatic lesions on bone scan; OR
• Radiologic 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 (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 consecutive PSA (2 measurements at least 1 weeks apart);
• Worsening clinical symptoms;
• Radiologic evidence demonstrating enlarged metastatic lesions 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).
• 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).
• 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).

Key Exclusion Criteria:

• A patient will not be eligible for inclusion in the study if any of the following criteria apply: 1. A medical history of brain or hepatic metastases based on radiologic evidence or a medical history of surgical castration; 2. Received combination treatment with a GnRH analog or GnRH receptor antagonist with either abiraterone acetate plus a corticosteroid (Part 1) or apalutamide (Part 2) in patients with mCSPC (Part 1 and Part 2) or nmCRPC (Part 2) for a total duration > 24 months or in patients with mCRPC (Part 1) for a total duration > 6 months; 3. Is scheduled or anticipates being scheduled for major surgery during the study treatment period; 4. A current diagnosis of a malignancy other than prostate cancer, with the exception of any of the following:
• Adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of any type;
• Adequately treated Stage I cancer that is currently in remission and has been in remission for ≥ 2 years;
• Any other cancer from which the patient has been disease-free for ≥ 3 years; 5. Abnormal clinical laboratory test value(s) at the screening visit or prior to the baseline (Day 1) visit including:
• Serum creatinine > 2.0 mg/dL;
• Platelets < 100 × 103/μL;
• Hemoglobin < 10.0 g/dL;
• Leukocytes (WBC) < 3 × 103/μL;
• Absolute neutrophil count < 1.5 × 103/μL;
• Hemoglobin A1c (HbA1c) > 8%; Note (Part 3 only): Transfusions and/or administration of growth factors are permitted as indicated for the clinical management of docetaxel-related hematologic effects and in accordance with the investigator's judgement. 6. Known hepatic disease, including alcoholic liver disease or viral hepatitis such as hepatitis A (hepatitis A virus IgM positive), chronic hepatitis B (HbsAg positive), or chronic hepatitis C (HCV antibody positive, confirmed by HCV RNA) or clinical signs of hepatic disease such as jaundice; 7. A medical history within 6 months prior to the screening visit or a current diagnosis of any of the following:
• Myocardial infarction;
• Unstable angina;
• Unstable symptomatic ischemic heart disease;
• Congestive heart failure classified as NYHA class III or IV heart failure;
• Thromboembolic event(s) (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular event[s]);
• Any other significant cardiac condition (eg, pericardial effusion, restrictive cardiomyopathy, severe untreated valvular stenosis, or severe congenital heart disease); 8. An abnormal ECG 9. Uncontrolled hypertension 10. Hypotension 11. Bradycardia 12. Positive HIV 13. Medical history of a bleeding disorder or current clinical evidence of gastrointestinal bleeding or active bleeding from another anatomical location. 14. A medical history within 1 year of the screening visit of drug or alcohol abuse disorder according to Diagnostic and Statistical Manual of Mental Disorders V 15. Received an investigational drug within 28 days or 5 half-lives, whichever is longer, prior to the baseline (Day 1) visit; 16. Prior use of any prohibited medication(s) and restrictive medication(s) without the appropriate washout period or use of a prohibited medication during the study treatment period is planned; 17. A contraindication or known history of hypersensitivity to any of the study treatments or components thereof, or has a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates study participation; 18. Any other medical or psychiatric condition that, in the opinion of the investigator, would interfere with accomplishing the study objectives or the patient completing the study; 19. Is a study site employee or is a primary family member (spouse, parent, child, or sibling) of a site employee involved in the conduct of the study.

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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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Condition: Biochemically Recurrent Prostate Carcinoma, Castration-Resistant Prostate Carcinoma, Prostate Adenocarcinoma, Stage IV 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 (initial staging cohort), high risk characteristics, including any of the following:
• Grade group 4-5 and/or
• PSA > 20 ng/mL
• For patients with biochemical recurrence (biochemical recurrence cohort):
• 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 (treatment monitoring cohort):
• Diagnosis of metastatic castration-resistant prostate cancer
• At least one or more measurable ( > 1 cm diameter in short axis) or evaluable lesions by any modality obtained within the past 60 days
• Planned for treatment with standard of care androgen receptor pathway inhibitor or chemotherapy
• This can include patients who have already undergone a standard of care Ga-68 PSMA PET/CT or PET/MR for determining eligibility for Lu-177 PSMA therapy, for whom the PET/CT or PET/MR did not confirm eligibility for treatment with Lu-177 PSMA, and who are planned to start treatment on chemotherapy or androgen receptor signaling inhibitor (ARSI) within 30 days of the Ga-68 PSMA PET. This can also include patients who have obtained a standard of care Ga-68 PSMA PET/CT or PET/MR for rising PSA to help with restaging prior to starting new treatment with ARSI or chemotherapy, even if Lu-177 PSMA is not being considered at that time. Scan 1 must be completed within 30 days of enrollment. Any patient with an equivocal lesion by conventional imaging, regardless of where they are in the course of evaluation or treatment (equivocal lesion cohort)
• 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)
• Eastern Cooperative Oncology Group/World Health Organization (ECOG/WHO) performance status grades 0, 1, or 2
• Ability to understand and willingness to provide informed consent

Exclusion Criteria:

• 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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Condition: Oligometastatic Hormone Sensitive Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04115007

Sponsor: UNICANCER

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

• 1. Histologically proven adenocarcinoma of the prostate (any T stage, Gleason score, or prostate specific antigen (PSA) level); 2. Defined as M1 based on the presence of at least one bone metastasis; 3. Diagnostic workup including functional imaging (F or C-Choline-PET/CT or prostate specific membrane antigen (PSMA) PET/CT or whole body MRI)
• done prior to the start of hormonal therapy; 4. With up to 5 asymptomatic or paucisymptomatic metastatic sites including at least one bone +/- pulmonary lesion +/- nodal mestastases. Are counted as a "separate" metastatic site :
• each bone lesion, whatever the location (including pelvic localization), except if two lesions show hyperfixation in the same bone and are located < 1cm from each other they can be counted as one lesion
• each node or nodal area located outside the true pelvis with a small diameter of 1cm or greater or with univoqual abnormal function imaging (PET Scan hyperfixation or hypersignal in whole body MRI); if multiple nodes are in close vicinity (<1cm distance between them and <4cm in total distance including the nodes, amenable to one SBRT treatment) they can be counted as one lesion
• and patients with lung metastasis can be included 5. Patients with a previous prostatectomy or radiotherapy to the prostate and/or pelvic lymph nodes are eligible provided they have no active disease within the irradiated areas, based on functional imaging findings; 6. Age ≥18 years; 7. Eastern Cooperative Oncology Group (ECOG) ≤2; 8. Suitable for long term anti androgen therapy; 9. Patient not suitable for docetaxel or abiraterone can be included; 10. Patient that have started long term hormonal therapy are eligible if hormonal therapy has been initiated less than 2 months before randomization; 11. Patients must agree to use adequate contraception methods for the duration of study treatment and for 6 months after completing treatment; 12. Patient must have received the information sheet and signed the consent form; 13. Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures; 14. Patient must be affiliated to the social security system. NON-INCLUSION CRITERIA: 1. Patient with more than 5 metastatic sites; 2. Patient with isolated Rib hyperfixation on functional imaging without a clear correlate on morphological imaging; 3. Patient with metastatic sites other than bone, lymph nodes or lung; 4. Metastases not amenable to radiotherapy treatment with high/curative doses by multidisciplinary meeting [i.e. SBRT as per protocol or curative doses using moderate hypofractionation (55-60Gy/20) or conventional fractionation (≥74 Gy)] (e.g. gross epidural involvement, involvement of three contiguous vertebral bodies, major soft tissue involvement, and previous radiation treatment); 5. Metastases requiring immediate treatment due to significant pain (use of opioid medication), or at risk of fracture or neurological deficit; 6. Prior radiotherapy or focal ablative treatment (cryotherapy, radiofrequency ablation,…) to metastatic lesions; 7. Patients previously treated by Hormonotherapy with castrate testosterone level <50 ng/dL or ≤0.50 ng/mL or 1.73 nmol/L prior use of ADT; 8. Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for ≥5 years; 9. Contra-indication to MRI (needed for spinal SBRT); 10. Persons deprived of their liberty or under protective custody or guardianship; 11. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons; 12. Participation in another therapeutic trial within 30 days prior to randomization.

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