Prostate Cancer

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A Phase 2, Open-Label, Single-Arm Study of BGB-290 (BGB-290) for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Homologous Recombination Deficiency (HRD)


Condition: Metastatic Castration-Resistant Prostate Cancer (mCRPC), HRD

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03712930

Sponsor: BeiGene

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Men (> 18 years of age) with histologically or cytologically confirmed adenocarcinoma or poorly differentiated adenocarcinoma of the prostate without neuroendocrine differentiation with HRD deficiency by CTC-HRD assay and/or deleterious germline or somatic mutation in BRCA1 or BRCA2; mCRPC measurable disease and/or bone disease. • PSA progression with > 3 rising PSA levels with > 1 week between determinations and a screening PSA > 2 μg/L (2 ng/mL).
  • Must be surgically or medically castrated with serum testosterone levels of < 1.73 nmol/L (50 ng/dL), must have received > 1 prior androgen receptor-targeted therapy, and must have received > 1 taxane-based therapy.
  • mCRPC with 1 or 2 of the following:
  • Measurable disease per RECIST v1.1
  • Bone disease
  • CTC-HRD+ or BRCA1/2 mutation
  • PSA progression (PCWG3 criteria)
  • ≥1 androgen receptor-targeted therapy (eg, abiraterone acetate/prednisone or enzalutamide) for mCRPC with progressive disease
  • ≥1 taxane for metastatic prostate cancer
  • Prior sipuleucel-T and checkpoint inhibitors"

Exclusion Criteria:

  • Chemotherapy, hormonal therapy, biologic therapy, radionuclide therapy, immunotherapy, investigational agent, anticancer Chinese medicine, or herbal remedies ≤ 5 half-lives if the half-life is known, ≤ 14 days if not known, before start of study treatment
  • Continued treatment with a bisphosphonate or denosumab is allowed, if administered at a stable dose > 28 days before start of study treatment
  • Radiotherapy ≤ 21 days (≤ 14 days, if single fraction of radiotherapy) before start of study treatment
  • Prior treatment for prostate cancer with any of the following:
  • PARP inhibitor
  • Platinum
  • Cyclophosphamide
  • Mitoxantrone"

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A Phase I Trial of Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer (CRPC)


Condition: Metastatic Castrate Resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03737370

Sponsor: Tufts Medical Center

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  1. Histologically or cytologically confirmed adenocarcinoma of the prostate
  2. Documented metastatic castration resistant disease with PSA progression, radiographic progression, or both, despite medical or surgical castration
  3. Two or more bone metastases detected on skeletal scintigraphy
  4. No more than one prior second generation androgen receptor inhibitor
  5. Eligible for docetaxel chemotherapy
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  7. Adequate organ function:
  8. Hemoglobin > 10 g/dL
  9. Absolute Neutrophil Count > 1,500 K/mL
  10. Platelet count > 150,000 x 10^9/L
  11. Total bilirubin < 1.5x upper limit of normal range, excluding Gilbert syndrome
  12. Serum aspartate aminotransferase (AST) < 1.5 x upper limit of normal range
  13. Serum alanine aminotransferase (ALT) < 1.5 x upper limit of normal range
  14. Calculated creatinine clearance > 30mL/min
  15. Age ≥ 18 years
  16. Ongoing castration (androgen deprivation therapy or prior orchiectomy)
  17. Male subjects with female sexual partners of childbearing potential must agree to use at least one highly effective methods of birth control.
  18. Ability to understand and willingness to sign an informed consent form prior to initiation of any study procedures.

Exclusion Criteria:

  1. Prior radionuclide therapy for CRPC
  2. Prior docetaxel for CRPC. (Permitted if given for castration sensitive disease > 6 months prior).
  3. Antiandrogen therapy within 4 weeks of enrollment. However, patients with primary failure of secondary anti-androgen therapy OR symptomatic progression, objective progression and/or biochemical evidence of rising PSA less than 4 weeks after discontinuation of anti-androgen therapy will not have anti-androgen withdrawal responses and will not be excluded.
  4. Preexisting peripheral neuropathy grade 2 or higher.
  5. Other serious medical condition as judged by the investigator.
  6. Active second malignancy that requires therapy.
  7. Known brain or leptomeningeal metastases
  8. Concurrent enrollment in any other investigational anticancer therapy
  9. Treatment with any myelosuppressive agent within 30 days of enrollment
  10. Presence of bulky visceral metastases, defined as any of the following:
  11. ≥ 4 lung lesions (at least 1cm each in size in the longest diameter) or pulmonary lymphangitic metastasis
  12. Liver metastases with sum of lesion diameters totaling ≥ 5cm
  13. Evidence of neuroendocrine or small cell differentiation on prior biopsy
  14. History of severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80

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Phase 3, Multicenter, Randomized Study, Evaluating the Efficacy and Tolerability of Focused HIFU Therapy Compared to Active Surveillance in Patients With Significant Low Risk Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03531099

Sponsor: Hospices Civils de Lyon

Phase: Phase 3

Eligibility:

  • Age: minimum 50 Years maximum 80 Years
  • Gender: Male

Inclusion Criteria:

  • Patient having been clearly informed of the study and having accepted, with sufficient reflection time, to participate by signing the informed consent form of the study.
  • Age between 50 and 80 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have G8 score > 14.
  • Initial diagnosis of localized prostate cancer (T1c or T2a) with the following characteristics:
  • Visible tumor on MRI: a multiparametric MRI showing a single invasive tumor focus at most two contiguous sextants confirmed by biopsies (index tumor). Patients with multiple suspected MRI foci may be included if only one of these foci is confirmed by targeted biopsies.
  • A maximum tumor length> 3 mm or at least 3 positive biopsies on all biopsies performed (randomized biopsies and/or targeted biopsies).
  • Gleason 6 score (risk group 1 of the D'Amico classification).
  • Tumor accessible to a Focal-HIFU treatment. For apical tumor, it must be localized more than 9 mm from the external sphincter.
  • PSA ≤ 15ng / ml.
  • Patient affiliated with health insurance or beneficiary of an equivalent plan.

Exclusion Criteria:

  • Contraindications to treatment with HIFU-F:
  • Tumor not accessible.
  • Multiple intra prostatic calcifications inducing, on ultrasound, a shadow cone in the prostate preventing the penetration of ultrasound and thus the realization of the treatment.
  • History of pelvic irradiation
  • Presence of an implant (stent, catheter) located less than 1 cm from the treatment area.
  • Fistula of the urinary tract or rectum.
  • Anal or rectal fibrosis, anal or rectal stenosis or other abnormalities making it difficult to insert the Focal One® probe.
  • Anatomical abnormality of the rectum or rectal mucosa.
  • Patient with artificial sphincter, penile prosthesis or intra prostatic implant, eg stent.
  • History of intestinal inflammatory pathology.
  • Uro-genital infection in progress (the infection to be treated before HIFU treatment).
  • Anterior surgery at the level of the anus or rectum making the introduction of the probe impossible.
  • Allergy to latex.
  • Thickness of the rectal wall> 10mm.
  • TURP indication. Bladder neck incision is allowed .
  • Patient with a medical contraindication to Sonovue® injection.
  • Patient with a medical contraindication on MRI.
  • Patient already treated for prostate cancer (hormone therapy, radiotherapy, surgery).
  • History of uncontrolled cancer and / or treated for less than 5 years (with the exception of basal cell skin cancer).
  • History of sclerosis of the bladder neck or urethral stenosis.
  • Patient with a several bleeding risk according to medical advice (patient with oral anticoagulant therapy must receive an alternative therapy if randomized in HIFU-F arm).
  • Patients with unstable neurological pathology.
  • Patient who has been treated for a therapeutic trial within 30 days of enrollment or who wishes to participate in an ongoing study that may interfere with this study.
  • Legal person protected by law.
  • Patient not able to understand the objectives of the study or refusing to comply with postoperative instructions.

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Princess Margaret Cancer Centre 18F-DCFPyL PET Registry


Condition: Carcinoma of Prostate

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03535831

Sponsor: University Health Network, Toronto

Eligibility:

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

Inclusion Criteria:

  • Patients will be eligible for inclusion in this study if they meet all of the following criteria:
  • Age ≥ 18 years
  • Histologic diagnosis of carcinoma of prostate
  • Being staged or restaged for any of the following indications: A. Staging of patients with: i. High risk disease; defined as at least one of the following: a. Gleason ≥8, b. ≥T3 disease, c. PSA >20 ng/ml; ii. Unfavourable intermediate-risk disease defined as: a. more than one intermediate-risk factor (cT2b/ cT2c; GS=7; serum PSA of 10-20 ng/ml); or b. Gleason score of 4+3=7 or more; or c. greater than 50% positive biopsy cores. B. Staging or restaging of PCa with equivocal findings on conventional workup: i. Patients with PCa being staged or restaged with equivocal findings on conventional workup (CT, bone scan, MRI); to help guide management or select appropriate site for biopsy to establish disease status. C. Restaging of patients with: i. Biochemical failure (BCF) after primary therapy (radical prostatectomy or primary radiotherapy), or ii. BCF after salvage therapy/therapies when further treatment is being considered or iii. Pathologically involved nodes at time of radical prostatectomy or iv. Persistently detectable PSA (>0.1 ng/ml) >3 months after prostatectomy 5.1.4 Ability to provide written informed consent to participate in the study

Exclusion Criteria:

  • Patients will be ineligible to participate in this study if they meet any of the following criteria:
  • Inability to lie still for PET/CT or PET/MR examination
  • For patients undergoing PET/MR only, any contraindication to MRI as per Joint Department of Medical Imaging policies (this exclusion criterion would not exclude patient from enrolling in the registry and undergoing PET/CT).
  • Patients with documented, clear-cut metastatic disease on conventional workup where PET findings would not potentially alter patient management. In case of uncertainty, the patient will be discussed at multidisciplinary tumor boards and a majority decision will be made

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68GA-PSMA FUSION PET/MRI FOR IMAGE-GUIDED PROSTATE BIOPSIES


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03689582

Sponsor: University of Michigan Rogel Cancer Center

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Recent MRI of the prostate has resulted in at least one lesion suspected to represent prostate cancer (reported by the Radiologist as PI-RADS 3, 4 or 5 lesion)
  • Treating physician has already indicated a need for a prostate biopsy procedure.
  • Known Gleason 6 or 7 prostate cancer OR rising PSA with either a) no prior biopsy or b) single or multiple negative prior biopsies.

Exclusion Criteria:

  • Prostate biopsy within 12 weeks before enrollment
  • Acute prostatitis within the last 6 months
  • Current non-urologic bacterial infection requiring active treatment with antibiotics
  • Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
  • Body weight greater than 350 lbs (158 Kg)
  • Inability or unwillingness to receive a prostate biopsy procedure
  • Unable to lie flat, still, or tolerate a PET/CT scan
  • Unable to provide own consent
  • Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 6 months prior to study participation, unstable and uncontrolled hypertension, acute renal failure of any intensity, chronic renal or hepatic disease, severe pulmonary disease).

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Phase II Randomized Study Of Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide For Intermediate-High Risk Prostate Cancer Undergoing Prostatectomy


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02903368

Sponsor: Dana-Farber Cancer Institute

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Male ≥ 18 years of age. 2. Histologically confirmed adenocarcinoma of the prostate without histological variants comprising >50% of the sample as determined by academic center central review (including neuroendocrine differentiation, small cell, sarcomatoid, ductal adenocarcinoma, squamous or transitional cell carcinoma). 3. Must have 3 core biopsies involved with cancer (a minimum of 6 core biopsies must be obtained). Prostate biopsy must be within seven months from screening. Less than 3 core biopsies are allowed if the patient has >1 cm or T3 disease on MRI. 4. Patients must have the following features:
  • Gleason ≥ 4+3=7 OR
  • Gleason 3+4=7 AND at least one of the following: PSA >20 ng/dL or T3 disease (as determined by MRI). 5. No evidence of metastatic disease as determined by radionuclide bone scans and CT/MRI. Lymph nodes must be less than 20 mm in the short (transverse) axis. 6. Participants must be candidates for RP and considered surgically resectable by urologic evaluation. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 8. Participants must have normal organ and marrow function as defined below:
  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1,500/mcL
  • Platelets ≥ 100,000/mcL, independent of transfusions/growth factors within 3 months of treatment start
  • Serum potassium ≥ 3.5 mmol/L
  • Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN) (except in subjects with Gilbert's syndrome who have a total bilirubin > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible)
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN
  • Serum albumin ≥ 3.0 g/dL
  • Serum creatinine < 2.0 x ULN
  • PTT≤60 9. Participant must agree to use a condom (even men with vasectomies) and another effective method of birth control if having sex with a woman of childbearing potential or must 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. Participant must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug. 10. Medications known to lower the seizure threshold (see list under APPENDIX D: Representative Medications that May Predispose to Seizure) must be discontinued or substituted at least 1 week prior to study treatment.

Exclusion Criteria:

  • 1. Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens (including first-generation antiandrogens, enzalutamide, Apalutamide and others), CYP17 inhibitors (including abiraterone acetate, TAK-700, galeterone, ketoconazole, and others), estrogens, Luteinizing Hormone Releasing Hormone (LHRH) agonist/antagonists. Prior therapy with 5α-reductase inhibitors is allowed. LHRH therapy allowed if begun within 4 weeks of day 1. 2. Prior chemotherapy, radiation therapy, or immunotherapy for prostate cancer. 3. Prior systemic treatment with an azole drug within two weeks of start of treatment. 4. Hypogonadism or severe androgen deficiency as defined by screening serum testosterone < 200 ng/dL. 5. Clinically significant cardiovascular disease within 6 months of study treatment including:
  • Severe or unstable angina;
  • Myocardial infarction;
  • Symptomatic congestive heart failure;
  • New York Heart Association (NYHA) class II-IV heart disease;
  • Arterial or venous thromboembolic events (such as pulmonary embolism cerebrovascular accident including transient ischemic attacks);
  • History of clinically significant ventricular arrhythmias (e.g. ventricular tachycardia, ventricular fibrillation, torsades de pointes);
  • Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on screening EKG > 470 msec;
  • History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place;
  • Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg). Participants with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy. 6. History of seizure or any condition or concurrent medication that may predispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to randomization, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect). 7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Apalutamide, abiraterone acetate, or other study drugs. 8. Severe hepatic impairment (Child-Pugh Class C). 9. Active infection (such as human immunodeficiency virus (HIV) or viral hepatitis) or other medical condition that would make prednisone / prednisolone corticosteroid use contraindicated. 10. History of pituitary or adrenal dysfunction. 11. Gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug. 12. Pre-existing condition that warrants long-term corticosteroid use greater than the equivalent of 10 mg prednisone daily. Physiologic replacement is permitted. Topical, intra-articular, or inhaled corticosteroids are permitted. 13. Concomitant use of medications that may alter pharmacokinetics of abiraterone acetate or Apalutamide. 14. Individuals with a history of a different malignancy are ineligible except for the following circumstances: 1) individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy, or 2) individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: non-muscle invasive bladder cancer, basal cell or squamous cell carcinoma of the skin. 15. Major surgery or radiation therapy within 30 days of screening visit. Participants who have had a major surgery within 30 days of screening visit may be eligible provided the treating investigator deems that the participant is at low risk for complications. 16. Any condition that in the opinion of the investigator would preclude participation in this study.

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Study of 18F-DCFPyL PET/CT, for Detection of Radiological Progression in Patients With Metastatic (M+) and Non-metastatic (M0) Castration Resistant Prostate Cancer Receiving Standard Androgen Receptor Targeted Treatment


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03800784

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase: Phase 2/Phase 3

Eligibility:

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

Inclusion Criteria:

  • Histological confirmation of prostate cancer
  • Patients receiving androgen deprivation treatment (ADT) with GnRH analogs, GnRH antagonists or bilateral orchiectomy of any duration.
  • Cohort A: nmCRPC (status post- primary treatment with radical prostatectomy, radiation of any type or both)
  • Negative 99mTc-methylene diphosphonate bone scan and CT of the chest abdomen and pelvis within 6 weeks of 18F-DCFPyL PET/CT
  • Treatment with ADT with or without a second line novel AR targeted treatment (abiraterone, enzalutamide, or both) or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted) for ≥ 12 months.
  • Rising PSA ≥ 10 ng/ml (confirmed by 2 determinations one week apart)
  • PSADT ≤ 9 months
  • Cohort B: mCRPC
  • Treatment with ADT with or without abiraterone and or enzalutamide or both for ≥ 6 months and/or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted).
  • PSA ≥ 2.0 ng/ml confirmed X 1 week apart, any PSADT
  • Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility.
  • No new therapeutic interventions planned or scheduled to be instituted prior to the course of this study both on cohorts A and B before conventional radiologic progression is evidenced.
  • Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.

Exclusion Criteria:

  • Patient will be excluded from enrollment if he had a radioisotope within 5 physical half-lives prior to PET imaging

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177Lu-PSMA-I&T PSMA Radioligand Therapy in Metastatic Castration-Resistant Prostate Cancer


Condition: Metastatic Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04188587

Sponsor: Nanjing First Hospital, Nanjing Medical University

Phase: Phase 2

Eligibility:

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

Exclusion Criteria:

  1. Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.
  2. Hemoglobin<80g/L;Hemameba<2.5×109/L;Thrombocyte<70g/L
  3. Glomerular filtration rate<50ml/min
  4. Serum creatinine>130umol/L;Total bilirubin>2mg/L;Albumin<30g/L.
  5. International normalized ratio(INR)>1,5
  6. Alanine aminotransferase, aspartate aminotransferase is 5 times larger than normal value

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IV Study of Apalutamide in Chinese Subjects With Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC)


Condition: Prostatic Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04108208

Sponsor: Janssen Research & Development, LLC

Phase: Phase 4

Eligibility:

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

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features, with high risk for development of metastases, defined as prostate-specific antigen doubling time (PSADT) less than or equals to (<=) 10 months. PSADT is calculated using at least 3 prostate-specific antigen (PSA) values obtained during continuous androgen deprivation therapy (ADT)
  • Castration-resistant prostate cancer (PC) demonstrated during continuous ADT, defined as 3 PSA rises at least 1 week apart, with the last PSA greater than (>) 2 nanogram per milliliter (ng/mL)
  • Surgically or medically castrated, with testosterone levels of less than (<) 50 nanogram per deciliter (ng/dL). If the participant is medically castrated, continuous dosing with gonadotropin releasing hormone analog (GnRHa) must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study to maintain castrate levels of testosterone
  • Participants who received a first-generation anti-androgen (example: bicalutamide, flutamide, nilutamide) must have at least a 4-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after washout
  • At least 4 weeks must have elapsed from major surgery or radiation therapy prior to randomization

Exclusion Criteria:

  • Presence of distant metastases, including central nervous system (CNS) and vertebral or meningeal involvement, or history of distant metastases. Exception: Pelvic lymph nodes <2 centimeter in short axis (N1) located below the iliac bifurcation are allowed
  • Symptomatic loco-regional disease requiring medical intervention, such as moderate or severe urinary obstruction or hydronephrosis, due to primary tumor (example, tumor obstruction of bladder trigone)
  • Prior treatment with cytochrome P450 17 alpha-hydroxylase/17,20-lyase (CYP17) inhibitors (example: abiraterone acetate, orteronel, galerterone, ketoconazole, aminoglutethimide) for PC
  • Prior chemotherapy for PC, except if administered in the adjuvant/neoadjuvant setting
  • History of seizure or condition that may pre-dispose to seizure (example: prior stroke within 1 year prior to randomization, brain arteriovenous malformation, schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)

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A Phase II Clinical Study of SHR3680 Combined With SHR3162 in the Treatment of Metastatic Castration-resistant Prostate Cancer Previously Treated With Abiraterone and Docetaxel


Condition: Prostate Cancer, Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04102124

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; does not suggest neuroendocrine or small cell characteristics
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1;
  3. Radiographic evidence of metastasis;
  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. Patient has been treated with Abiraterone and treatment failed(Treatment failure is defined as the progression of disease during treatment)
  9. Patient has been treated with Docetaxel and treatment failed or can not tolerate docetaxel chemotherapy or patients who are not suitable for docetaxel treatment at the time of screening.

Exclusion Criteria:

  1. Have received any anti-tumor therapy in the past 4 weeks,including radiotherapy, chemotherapy, operation, targeted therapy, immuntherapy, and endocrinotherapy;
  2. Planned to initiate any other anti-tumor therapies during the study;
  3. Unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption;
  4. Clinically significant cardiovascular diseases;
  5. History of seizure or certain conditions that may predispose to seizure;
  6. Severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.

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A Phase II Randomized Trial of RAdium-223 and SABR Versus SABR for oligomEtastatic Prostate caNcerS (RAVENS)


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04037358

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone or soft tissue (with at least one bone metastasis) develop within the past 6-months that are ≤ 5.0 cm or <250 cm3
  • Patient must have had their primary tumor treated with surgery and/or radiation.
  • Histologic confirmation of malignancy (primary or metastatic tumor).
  • PSADT <15 months. PSA doubling time (PSADT) will be calculated using as many PSA values that are available from time of relapse (PSA > 0.2). To calculate PSADT, the Memorial Sloan Kettering Cancer Center Prostate Cancer Prediction Tool will be used. It can be found at the following web site: https://www.mskcc.org/nomograms/prostate/psa-doubling-time.
  • Patient may have had prior systemic therapy and/or ADT associated with treatment of their primary prostate cancer. Patient may have had ADT associated with salvage radiation therapy (to the primary prostate cancer or pelvis is allowed).
  • PSA > 0.5 but <50.
  • Testosterone > 125 ng/dL.
  • Patient must be ≥ 18 years of age.
  • Patient must have a life expectancy ≥ 12 months.
  • Patient must have an ECOG performance status ≤ 2.
  • Patient must have normal organ and marrow function as defined as: Before the first administration of Xofigo, the absolute neutrophil count (ANC) should be ≥ 1.5 x 109/L, the platelet count ≥ 100 x 109/L and hemoglobin ≥ 10 g/dL. * Patient must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • No more than 3 years of ADT is allowed, with the most recent ADT treatment having occurred greater than 6 months prior to enrollment.
  • PSMA-PET/MRI or PSMA-PET/CT scan within the past 6 months with results that demonstrate more disease lesions than baseline CT/Bone Scan
  • Castration-resistant prostate cancer (CRPC).
  • Spinal cord compression or impending spinal cord compression.
  • Suspected pulmonary and/or liver metastases (greater >10 mm in largest axis).
  • Patient receiving any other investigational agents.
  • Patient receiving abiraterone and prednisone.
  • Patient is participating in a concurrent treatment protocol.
  • Serum creatinine > 3 times the upper limit of normal.
  • Total bilirubin > 3 times the upper limit of normal.
  • Liver Transaminases > 5-times the upper limit of normal.
  • Unable to lie flat during or tolerate PET/MRI, PET/CT or SBRT.
  • Prior salvage treatment to the primary prostate cancer or pelvis is allowed.
  • Refusal to sign informed consent.

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A Phase 2 Study of a Checkpoint Inhibitor in Men With Progressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation


Condition: Metastatic Castration Resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04104893

Sponsor: VA Office of Research and Development

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Subject must be 18 years of age or older at the time the Informed Consent is signed.
  • The subject (or legally acceptable representative if applicable) must provide written informed consent for the trial.
  • Pathologic diagnosis of prostate cancer of adenocarcinoma or small cell histology.
  • Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). CT-portion of FDG-PET/CT or scan may be used for eligibility. NaF PET-CT is an alternative to 99mTc bone scan. If lymph node metastasis is the only evidence of metastatic disease, it must be 1.5 cm in short axis and above the level of the iliac bifurcation. Imaging studies for the purpose of determining eligibility must be completed within 60 days of Day 1.
  • Progressive castration resistant prostate cancer as defined by serum testosterone < 50 ng/mL and one of the following:
  • PSA progression confirmed per Prostate Cancer Clinical Trials Working Group (PCWG3),
  • Radiographic progression of soft tissues according to Response Evaluation Criteria in Solid Tumors, version 1.1 (iRECIST 1.1) modified based on PCWG3, or radiographic progression of bone according to PCWG3.
  • Prior use of a novel AR signaling inhibitor for 4 weeks, including abiraterone acetate plus prednisone/prednisolone, enzalutamide, apalutamide, and/or darolutamide. NOTE: These AR signaling inhibitors may have been used for mCSPC, M0CRPC, and/or mCRPC.
  • Ongoing surgical or medical castration, with testosterone levels of <50 ng/dL. If the subject is being treated with GnRH analogs (subject who has not undergone bilateral orchiectomy), this therapy must have been initiated at least 30 weeks prior to initiation of pembrolizumab and must be continued throughout the study.
  • ECOG PS grade of 0-2.
  • Metastatic lesion that is amenable to biopsy and performed within 180 days of Day 1.
  • dMMR or CDK12-/- as determined by somatic tumor DNA NGS.
  • Either monoallelic or biallelic inactivation of CDK12 on NGS is considered sufficient for eligibility purposes.
  • MMR genes include: MLH1, MSH2, MLH3, PMS1, MSH6, and PMS2.
  • dMMR is established by MSI-H on NGS. However, for "weak" MMR genes, inclusive of PMS2 and MSH6, monoallelic inactivation will be allowed for eligibility purposes if and only if there is at least MSI-low or hypermutation that is concomitantly present.
  • If there is biallelic inactivation of "strong" MMR genes (MLH1 and MSH2), then patients must manifest MSI-H. However, if the tumor DNA utilized for MSI analysis was obtained > 6 months prior to NGS, then the NGS should be repeated to determine if MSI-H has developed. Monoallelic inactivation of "strong" MMR genes will be allowed if MSI-H is present; in this scenario, it is presumed that biallelic inactivation is present but the second inactivating event was not detected due to technical issues such as low sensitivity for copy loss.
  • Adequate organ function:
  • Hemoglobin (hgb) > 9.0 g/dL,
  • Absolute neutrophil count (ANC) > 1500/ uL,
  • Platelets > 100,000/ uL,
  • Total bilirubin 1.5 x ULN OR direct bilirubin ULN for participants with total bilirubin levels >1.5 x ULN
  • ALT and AST 2.5 x ULN ( 5 x ULN for participants with liver metastases) (Child-Pugh class A and B allowed; Child-Pugh class C is excluded).
  • Creatinine < (2.0 mg/dL) during screening evaluation (>2.0 is allowed if EGFR >30 mL/min/1.73 m2).
  • Subject must agree to use contraception during the treatment period plus an additional 120 days after the last dose of study treatment and must refrain from donating sperm during this period.

Exclusion Criteria:

  • Brain metastases.
  • Prior treatment with an anti-PD1, anti-PDL1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
  • Anti-neoplastic therapies for prostate cancer must be completed > 2 weeks prior to Day 1 (initiation of pembrolizumab); chemotherapy must be completed > 4 weeks prior to Day 1.
  • Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks [could consider shorter interval for kinase inhibitors or other short half-life drugs] prior to [randomization /allocation]. Note: Participants must have recovered from all AEs due to previous therapies to Grade 1 or baseline. Participants with Grade 2 neuropathy may be eligible.
  • Herbal and non-herbal products that may decrease PSA levels other than medical castration and megestrol (up to 40 mg/day is allowed) for hot flashes.
  • Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation ( 2 weeks of radiotherapy) to non-CNS disease.
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
  • If a subject has undergone major surgery, they must have recovered adequately from the toxicities or complications from the intervention within 4 weeks prior to starting therapy.
  • History of non-prostate active malignancy requiring treatment in the 24 months prior to Day 1 except for non-muscle invasive urothelial cancer and non-melanoma skin cancer.
  • Active infection or conditions requiring treatment with antibiotics.
  • Immunosuppressive doses of systemic medications, such as corticosteroids (doses > 10 mg/day prednisone or equivalent), within 2 weeks of Day 1.
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Has a known history of active TB (Bacillus Tuberculosis).
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Active autoimmune disease or a documented history of autoimmune disease that requires immunosuppressive medications within the last two years (e.g., chronic steroids, methotrexate, tacrolimus, etc.).
  • Active or chronic hepatitis B or hepatitis C disease as determined by hepatitis B surface antigen (HBsAg), hepatitis B core antibody, or hepatitis C antibody (anti-HCV) positivity at screening. If positive, further testing of quantitative levels to rule out active infection is required.
  • History of positive test for human immunodeficiency virus (HIV). NOTE: Hepatitis B and C and HIV testing is NOT required during screening.
  • Vaccinated with a live vaccine within 30 days of enrollment.
  • Has severe hypersensitivity ( Grade 3) to pembrolizumab and/or any of its excipients.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Subject is planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.

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Darolutamide Observational Study in Non-metastatic Castration-resistant Prostate Cancer Patients


Condition: Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04122976

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 CRPC (Castration-Resistant Prostate Cancer) defined by disease progression despite ADT (Androgen-Deprivation Therapy) and may present as a confirmed rise in serum PSA levels (as defined by PCWG3 (Prostate Cancer Working Group 3)).
  • Decision to initiate treatment with darolutamide was made as per investigator's routine treatment practice prior to enrollment in the study
  • Signed informed consent
  • Life expectancy of ≥3 months

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 (more than 3 days prior to enrollment)

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A Phase 1 Dose Escalation and Expanded Cohort Study of P-PSMA-101 in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)


Condition: Prostatic Neoplasms, Castration-Resistant, Neoplasms by Histologic Type, Neoplasms, Prostate, Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Neoplasms, Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms by Site, Prostatic Disease

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04249947

Sponsor: Poseida Therapeutics, Inc.

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  • Males ≥18 years of age
  • Must have a confirmed diagnosis of mCRPC
  • Must have measurable disease by RECIST 1.1 or bone only metastases with measurable PSA (≥1 ng/mL)
  • Must have progressed by PCWG3 and/or RECIST 1.1
  • Must have adequate vital organ function within pre-determined parameters
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria:

  • Has inadequate venous access and/or contraindications to leukapheresis
  • Has an active second malignancy in addition to mCRPC, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma
  • Has active autoimmune disease
  • Has a history of significant central nervous system (CNS) disease, such as stroke or epilepsy
  • Has an active systemic infection
  • Has received anti-cancer medications (excluding GnRH targeted therapies) within 2 weeks or 5 half-lives (whichever is longer) of the time of initiating conditioning chemotherapy
  • Has received immunosuppressive medications (including anti-cancer medications) within 2 weeks of initiating leukapheresis and/or expected to require them while enrolled in the study
  • Has received systemic corticosteroid therapy within 2 weeks of either the required leukapheresis or is expected to require it during the course of the study
  • Has CNS metastases or symptomatic CNS involvement

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CIRCULATING MICRO-RNA (miRNA) AND AR-V7 MUTATIONAL STATUS IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC): PRIMERA+ STUDY (PROSTATE CANCER INNOVATING MARKERS OF EXPECTED RESPONSE TO AGONIST LHRH+ ANDROGEN RECEPTOR INHIBITION


Condition: D011471, D064129, D035683, D009360, D014408

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04188275

Sponsor: Azienda Ospedaliero-Universitaria Careggi

Phase:

Eligibility:

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

Inclusion Criteria:

  • Castration Resistant Prostate Cancer defined as biochemical or clinical progression under therapy with LHRH agonist and castrate plasma testosterone levels (<20 ng/dl or <1.73 nmol/L)
  • Eligible for medical treatment
  • Age >18 years
  • Informed consentment

Exclusion Criteria:

  • Medical contraindication/refusal to chemotherapy or endocrine therapy
  • Life expectancy inferior to 1 year
  • Previously diagnosed neoplasm

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Real World Evaluation of Access-driven Canadian Treatment Sequences in Progressive Prostate Cancer


Condition: Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04281147

Sponsor: Bayer

Phase:

Eligibility:

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

Inclusion Criteria:

  • Use of at least 2 lines of life-prolonging mCRPC therapy
  • The 2nd line of life-prolonging therapy was initiated between 01-Jan-2012 to 31-Dec-2017 Exclusion Criteria:
  • No formal

Exclusion Criteria:

  • No formal exclusion criteria will be applied in order to capture real world use of Ra-223

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A Phase Ib/II Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer


Condition: Metastatic Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04253262

Sponsor: Brown University

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Age ≥ 18 years 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 3. Life expectancy of at least 3 months 4. Histologically confirmed prostate cancer. Small cell/neuroendocrine differentiation allowed but not required for study participation. Pure small cell carcinoma of the prostate will not be allowed. 5. Progressive metastatic prostate cancer despite castrate levels of testosterone (< 50 ng/dL). 6. Patients may have either non-measurable disease OR measurable disease (by RECIST criteria) 7. Progressive disease during treatment (or within 4 weeks of completion) with abiraterone, enzalutamide, and/or apalutamide based on any one of the following:
  • For patients with measurable disease, progression by the RECIST 1.1 criteria
  • PSA evidence for progressive prostate cancer consists of a PSA level of at least 2 ng/ml which has risen on at least 2 successive occasions, at least one week apart. If the confirmatory PSA value is less than the screening PSA value, then an additional test for rising PSA will be required to document progression for the purposes of eligibility
  • Radionuclide bone scan: At least two new foci consistent with metastatic lesions 8. Testosterone < 50 ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone bilateral orchiectomy. 9. Progression or refractoriness to androgen pathway inhibitors (e.g., abiraterone, enzalutamide). Prior therapy with taxane in the castrate-sensitive or castration-resistant settings will be allowed. Prior treatment with radium-223 or sipuleucel-T is permitted, but not required. 10. No other systemic therapies for prostate cancer within 28 days prior to cycle 1 day 1 of study therapy 11. Left ventricular ejection fraction (LVEF) ≥ 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) obtained during screening 12. Patients must have adequate organ and bone marrow function within 14 days of inclusion in the study as defined below:
  • Absolute Neutrophil Count ≥ 1,500/mcL
  • Hemoglobin ≥ 9 g/dL
  • Platelets ≥ 100,000 /mm3
  • PT/INR ≤ 1.5 x ULN
  • Bilirubin ≤1.5 x institutional upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert's Syndrome, who can have total bilirubin <3.0 mg/dL
  • AST/ALT ≤ 3 x ULN (≤ 5 x ULN if liver metastases present)
  • Lipase ≤ 1.5 x ULN
  • HbA1c < 8.5 %
  • Serum Creatinine ≤ 1.5 X ULN (upper limit of normal) or creatinine clearance ≥ 45 mL/minute (using Cockcroft/Gault formula)
  • Proteinuria ≤ Grade 3 as assessed by a 24h protein quantification or estimated by a urine protein : creatinine ratio < 3.5 on a random urine sample 13. Sexually active males must use a condom with spermicide during intercourse while taking the drug and for 6 months after stopping treatment, even if patient is vasectomized to prevent delivery of the drug via seminal fluid. 14. Patients must agree to provide tumor tissue, either fresh or archival specimen of primary tumor and/or metastatic lesion, if available. Availability of tissue will not be required for enrollment. 15. Subjects must have the ability to understand and the willingness to sign a written informed consent prior to registration on study. Subjects should be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations at the institution. 16. Only during phase 2, patients will be required to have mutations in DNA repair genes based on molecular tests performed on germline DNA, prostate cancer tissue or ctDNA. Qualifying mutations (i.e. deleterious/pathogenic alterations) in at least one of the following genes involved with homologous recombination repair will be required: BRCA1, BRCA2, ATM, BARD1, BRIP1, CHEK1, FANCL, FANCA, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, and RAD54L. Variants of unknown significance in one of the above genes are not eligible. Exclusion Criteria: 1. History of myelodysplastic syndrome or acute myeloid leukemia. 2. During phase 2, patients must not have received previous treatment with a DNA-damaging cytotoxic chemotherapy (e.g. prior platinum-based chemotherapy and mitoxantrone are not permitted) or PARP inhibitor. Prior treatment with PARP inhibitor is allowed during phase I dose escalation. 3. Untreated leptomeningeal or metastatic CNS disease; patients with treated disease may be eligible if stable for 4 weeks after radiation or surgery. Steroid treatment should be stable for 4 weeks at a prednisone equivalent dose of 10 mg or less. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of stable disease for 28 days. 4. Clinically significant, uncontrolled heart disease and/or recent events including any of the following:
  • History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) or symptomatic pericarditis within 6 months prior to screening
  • History of documented congestive heart failure (New York Heart Association functional classification III-IV)
  • History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening. Patients with rate-controlled atrial fibrillation or flutter are permitted.
  • QTcF > 470 msec on screening 12-lead ECG
  • Documented cardiomyopathy 5. Clinically significant uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management). For the purpose of this protocol definition of uncontrolled hypertension is based on persistent (≥72 hours) and symptomatic. 6. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study medication. However, patients with a venous thrombosis, including a pulmonary embolus, how have had stable anticoagulation (more than 1 month without bleeding on a stable dose) is permitted. Patients with evidence or history of uncontrolled bleeding diathesis. Any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to the start of study medication 7. History or concurrent condition of clinically significant interstitial lung disease and/or severely impaired lung function. History of renal failure requiring peritoneal dialysis or hemodialysis. History of cirrhosis Child-Pugh B or C. Intestinal malabsorption. 8. Active, clinically serious infections of CTCAE (v 5.0) Grade ≥ 2 or per investigator discretion. 9. History of uncontrolled human immunodeficiency virus (HIV) infection defined as CD4 < 200 cells/mm3 or detectable viral load is not allowed. 10. Hepatitis B (HBV) or hepatitis C (HCV). All patients must be screened for HBV and HCV up to 28 days prior to study drug start using the routine hepatitis virus laboratorial panel. Patients positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA. These patients should receive prophylactic antiviral therapy. Patients positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA. CMV PCR positive or active tuberculosis are

Exclusion Criteria:

  • 1. History of myelodysplastic syndrome or acute myeloid leukemia. 2. During phase 2, patients must not have received previous treatment with a DNA-damaging cytotoxic chemotherapy (e.g. prior platinum-based chemotherapy and mitoxantrone are not permitted) or PARP inhibitor. Prior treatment with PARP inhibitor is allowed during phase I dose escalation. 3. Untreated leptomeningeal or metastatic CNS disease; patients with treated disease may be eligible if stable for 4 weeks after radiation or surgery. Steroid treatment should be stable for 4 weeks at a prednisone equivalent dose of 10 mg or less. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of stable disease for 28 days. 4. Clinically significant, uncontrolled heart disease and/or recent events including any of the following:
  • History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) or symptomatic pericarditis within 6 months prior to screening
  • History of documented congestive heart failure (New York Heart Association functional classification III-IV)
  • History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening. Patients with rate-controlled atrial fibrillation or flutter are permitted.
  • QTcF > 470 msec on screening 12-lead ECG
  • Documented cardiomyopathy 5. Clinically significant uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management). For the purpose of this protocol definition of uncontrolled hypertension is based on persistent (≥72 hours) and symptomatic. 6. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study medication. However, patients with a venous thrombosis, including a pulmonary embolus, how have had stable anticoagulation (more than 1 month without bleeding on a stable dose) is permitted. Patients with evidence or history of uncontrolled bleeding diathesis. Any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to the start of study medication 7. History or concurrent condition of clinically significant interstitial lung disease and/or severely impaired lung function. History of renal failure requiring peritoneal dialysis or hemodialysis. History of cirrhosis Child-Pugh B or C. Intestinal malabsorption. 8. Active, clinically serious infections of CTCAE (v 5.0) Grade ≥ 2 or per investigator discretion. 9. History of uncontrolled human immunodeficiency virus (HIV) infection defined as CD4 < 200 cells/mm3 or detectable viral load is not allowed. 10. Hepatitis B (HBV) or hepatitis C (HCV). All patients must be screened for HBV and HCV up to 28 days prior to study drug start using the routine hepatitis virus laboratorial panel. Patients positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA. These patients should receive prophylactic antiviral therapy. Patients positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA. CMV PCR positive or active tuberculosis are exclusion criteria. 11. Previous or concurrent history of malignancies within 5 years prior to study treatment except for curatively treated cervical carcinoma in situ, non-melanoma skin cancer, superficial bladder cancer (Ta [non-invasive tumor], Tis [carcinoma in situ] and T1 [tumor invades lamina propria]) or other T1 tumor that has been surgically removed with a low chance of recurrence in the next 3 years. 12. Known hypersensitivity to any of the test drugs, test drug classes, or excipients in the formulation 13. Ongoing substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results. 14. Prior radiation within 7 days of start drug. Prior major surgery, open biopsy or significant trauma within 28 days of start drug. 15. Patients with severe psychiatric illness/social situations that would limit compliance with study requirements in the judgment of study investigator 16. Patient has a history of non-compliance to medical regimen or inability to grant consent

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Exploratory Evaluation of Genetic Polymorphism and Pharmacodynamic Parameters in Samples of Abira-DES Study Subjects (NCT02217566) - Subjects With Metastatic Castration-Resistant Prostate Cancer Treated With Abiraterone Acetate Following Unresponsive Treatment With Diethylstilbestrol.


Condition: Metastatic Castration-resistant Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04268628

Sponsor: Janssen-Cilag Farmaceutica Ltda.

Phase:

Eligibility:

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

Inclusion Criteria:

  • Must have a confirmed diagnosis of prostate adenocarcinoma without neuroendocrine or small cell differentiation and was a participant in the Abira-DES study (NCT0221756), which includes: diethylstilbestrol pretreatment for castration-resistant prostate cancer with evidence of disease progression or grade 3/4 toxicity with diethylstilbestrol; metastatic disease confirmed by bone examination or metastatic lesions by computed tomography or magnetic resonance
  • Abiraterone acetate therapy during the Abira-DES study (NCT0221756), and peripheral blood samples have been collected from at least of the three proposed study timepoints
  • Must sign, and/or his/her legally acceptable representatives, where applicable, must sign the ICF allowing the use of clinical data and biological samples in accordance with local requirements. For deceased participants who did not provide consent prior to death, permission to research their information must meet local requirements

Exclusion Criteria:

  • Having withdrawn the consent to use the samples collected during their participation in the Abira-DES study (NCT02217566)

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Oligomet-DK. National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients


Condition: Prostate Cancer Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04086290

Sponsor: Peter Busch Østergren

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  1. Age 18 years or older and willing and able to provide informed consent;
  2. Stage cT1 ≤ cT3b, Clinical resectable
  3. Gleason score ≥ 6
  4. M1
  5. ≤ 3 bone metastases localized to the spine, pelvis or humeral/femoral bones as evaluated by 68Ga-PSMA PET/CT and magnetic resonance imaging (MRi)
  6. Absence of PSMA uptake in retroperitoneal lymph nodes, (outside the anatomical region of extended pelvic lymph node dissection as described in the European Association of Urology (EAU) guidelines.
  7. No visceral metastasis
  8. Metastases suitable for stereotactic body radiotherapy
  9. Non symptomatic bone lesions
  10. Eligible for surgery

Exclusion Criteria:

  1. Prior curative intended treatment for prostate cancer
  2. Prior androgen deprivation therapy (ADT)
  3. History of another invasive cancer within 3 years of screening, with the exception of fully treated cancers with a remote probability of recurrence. The medical monitor and investigator must agree that the possibility of recurrence is remote for exceptions.
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status > 1
  5. Evaluated not able to fulfil the study protocol.
  6. Contraindications against MRI

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A Randomized, Parallel Phase II Trial of Hypofractionated Proton Beam Therapy or IMRT for Recurrent, Oligometastatic Prostate Cancer Involving Only Pelvic and/or Para-Aortic Lymph Nodes Following Primary Localized Treatment


Condition: Metastatic Prostate Adenocarcinoma, Prostate Adenocarcinoma, Recurrent Prostate Carcinoma, 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: NCT04190446

Sponsor: Mayo Clinic

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Histological confirmation of prostate adenocarcinoma
  • Recurrent prostate cancer after prior receipt of primary radiotherapy to the prostate (can also include treatment of splenic vessels [SVs] and lymph nodes [LNs]) or salvage RT to the prostate fossa (can also include prior pelvic RT)
  • Oligometastatic extent of disease
  • Recurrent disease involving lymph nodes as diagnosed with choline positron emission tomography (PET)/computed tomography (CT) or other advanced PET imaging (prostate-specific membrane antigen [PSMA] or flucyclovine)
  • Limited to pelvic and/or retroperitoneal/para-aortic lymph nodes
  • Zubrod performance score (PS) =< 1
  • Signed informed consent

Exclusion Criteria:

  • Bone or visceral metastases present
  • Lymph node metastases beyond the pelvis and/or retroperitoneum
  • Contraindications to RT (e.g., uncontrolled inflammatory bowel disease)
  • Contraindications to androgen suppression
  • Concurrent antineoplastic agents (chemotherapy)
  • Previous or concurrent malignancy other than non-melanoma skin cancer within 5 years of diagnosis of prostate cancer
  • Inability to start the protocol treatment within 6 months after study enrollment
  • Medical or psychiatric conditions that preclude informed decision-making or compliance with the protocol treatment or follow-up

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