Prostate Cancer

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Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)


Condition: Prostate Cancer

Intervention:

  • Drug: Docetaxel 75 mg/m2
  • Drug: Docetaxel 60 mg/m2
  • Drug: Radium-223

Purpose: The purpose of this study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03574571

Sponsor: Memorial Sloan Kettering Cancer Center

Primary Outcome Measures:

  • Measure: Overall survival
  • Time Frame: 2 years
  • Safety Issue:

Estimated Enrollment: 738

Study Start Date: June 19, 2018

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Willing and able to provide written informed consent (ICF) and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
  • Males 18 years of age and above
  • Histological or cytological proof of prostate cancer
  • Documented progressive mCRPC based on at least one of the following criteria: 1. PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 1.0 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 1.0 ng/mL. 2. Soft-tissue progression defined as an increase ≥ 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions. 3. Progression of bone disease (evaluable disease) or two or more new bone lesions by bone scan.
  • Two or more bone lesions
  • ECOG 0- 1
  • Normal organ function with acceptable initial laboratory values within 14 days of randomization:
  • Albumin > 30 g/L
  • ANC ≥ 1.5 x 10^9/L
  • Hemoglobin ≥ 10 g/dL
  • Platelet count ≥ 100 x 10^9/L
  • Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN)
  • Bilirubin ≤ ULN (unless documented Gilbert's disease)
  • SGOT (AST) ≤ 1.5 x ULN
  • SGPT (ALT) ≤ 1.5 x ULN
  • WBC count ≥ 3 x 10^9/L
  • Subjects must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug. Sperm donation is prohibited during the study and for 30 days after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.
  • Serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy.
  • All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less.
  • Willing and able to comply with the protocol, including follow-up visits and examinations

Exclusion Criteria:

  • Received any other investigational therapeutic agents or other anticancer therapies within 4 weeks prior to randomization.
  • Received external beam radiotherapy within the 4 weeks prior to randomization.
  • Has an immediate need for external beam radiotherapy.
  • Has received any systemic bone-seeking radiopharmaceutical in the past.
  • Has received any prostate cancer directed chemotherapy in the castration resistant setting. Subjects who have received up to 6 prior doses of docetaxel in the castration sensitive setting are permitted if they have not experienced disease progression within 36 weeks of last treatment with docetaxel.
  • Has received four or more systemic anticancer regimens for mCRPC.
  • Treatment with docetaxel or abiraterone for non-castrate metastatic disease is permissible and does not count towards the lines of therapy for mCRPC
  • A 'line' is a regimen. Combinations of hormones and other types of therapies count as single lines.
  • Has known Grade ≥3 docetaxel-related toxicities or docetaxel toxicity related dose interruption or discontinuation.
  • Has received blood transfusions or growth factors within the last 4 weeks prior to randomization.
  • Symptomatic nodal disease (i.e., scrotal, penile, or leg edema).
  • Has visceral metastases with ≥ 3 lung and/or liver metastases or individual lesion ≥2 cm, as assessed by CT scan or MRI of the chest/abdomen/pelvis within the last 8 weeks prior to randomization.
  • Symptomatic loco-regional disease that causes ongoing Grade 3 or Grade 4 urinary or rectal symptoms.
  • Subjects with a "currently active" second malignancy other than non-melanoma skin cancers or non-invasive bladder cancers or other in-situ or non-invasive malignancies. Subjects are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
  • Has imminent or established cord compression based on clinical findings and/or MRI.
  • Known bone marrow dysplasia
  • Has received any of the following in the 4 weeks prior to randomization: 5-alpha-reductase inhibitors, herbal medications, natural hormonally active foods (e.g., phytoestrogens) or other food supplements known to alter PSA in humans
  • Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including but not limited to:
  • Uncontrolled infection
  • NYHA III or IV heart failure
  • Crohn's disease or those with ulcerative colitis who have not undergone a colectomy
  • Known active infection with HIV, Hepatitis B or Hepatitis C

Contact:

  • Michael Morris, MD
  • 646-422-4469

Locations:

  • University of Michigan Cancer Center
  • Ann Arbor Michigan 48109 United States
  • GU Research Network / Urology Cancer Center
  • Omaha Nebraska 68130 United States
  • Comprehensive Cancer Centers of Nevada
  • Las Vegas Nevada 89128 United States
  • Memoral Sloan Kettering Basking Ridge
  • Basking Ridge New Jersey 07920 United States
  • Memoral Sloan Kettering Monmouth
  • Middletown New Jersey 07748 United States
  • Memorial Sloan Kettering Bergen
  • Montvale New Jersey 07645 United States
  • Memorial Sloan Kettering Commack
  • Commack New York 11725 United States
  • Memorial Sloan Kettering Westchester
  • Harrison New York 10604 United States
  • Memorial Sloan Kettering Cancer Center
  • New York New York 10065 United States
  • Memorial Sloan Kettering Rockville Centre
  • Rockville Centre New York 11570 United States
  • MidLantic Urology
  • Bala-Cynwyd Pennsylvania 19004 United States

View trial on ClinicalTrials.gov


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Phase III Randomized Trial of 68Ga-PSMA-11 PET/CT Molecular Imaging for Prostate Cancer Salvage Radiotherapy Planning [PSMA-SRT]


Condition: Recurrent Prostate Carcinoma

Intervention:

  • Drug: 68Ga-PSMA-11

Purpose: To evaluate the success rate of salvage radiation therapy (SRT) for recurrence of prostate cancer after prostatectomy with and without planning based on 68Ga-PSMA-11 PET/CT.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03582774

Sponsor: Jonsson Comprehensive Cancer Center

Primary Outcome Measures:

  • Measure: Rate of biochemical progression-free survival
  • Time Frame: Time Frame: From date of initiation of salvage radiation therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: 5-year progression-free survival rate
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Metastasis free-survival
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Rate of additional prostate cancer therapy initiation-free survival
  • Time Frame: assessed up to 5 years
  • Safety Issue:

Estimated Enrollment: 193

Study Start Date: July 12, 2018

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • 1. Histopathology proven prostate cancer 2. Planned SRT for recurrence after primary prostatectomy 3. PSA ≥ 0.1ng/ml at time of enrollment 4. Willingness to undergo radiotherapy. 5. Treating radiation oncologist intends to incorporate 68Ga-PSMA-11 PET/CT findings into the radiotherapy plan if patient undergoes 68Ga-PSMA-11 PET/CT

Exclusion Criteria:

  1. Extra-pelvic metastasis on any imaging or biopsy
  2. Prior PSMA PET/CT
  3. Prior pelvic external beam radiation therapy (RT)
  4. Androgen deprivation therapy (ADT) within 3 months before 68Ga-PSMA-11 PET/CT
  5. Contraindications to radiotherapy (including active inflammatory bowel disease)
  6. Concurrent systemic therapy for prostate cancer with investigational agents. -

Contact:

  • Jeannine Gartmann
  • 310-206-0596

Location:

  • UCLA
  • Los Angeles California 90095 United States

View trial on ClinicalTrials.gov


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A Phase II Study to Determine Sequential Response to Bipolar Androgen Therapy (BAT) Followed by Enzalutamide or Abiraterone Post-BAT in Men With Prostate Cancer Progressing on Combined Androgen Ablative Therapies


Condition: Prostate Cancer

Intervention:

  • Drug: Testosterone cypionate
  • Drug: Testosterone Enanthate
  • Drug: Abiraterone acetate
  • Drug: Enzalutamide (Cohort A = CLOSED TO ACCRUAL)

Purpose: Single-arm, single site, open label study of the effects of parenteral testosterone followed by enzalutamide or abiraterone or castration-only therapy in men with metastatic CRPC who previously progressed on one of these forms of therapy. The study will enroll three cohorts of patients: men with metastatic CRPC who have progressed on enzalutamide (Cohort A); men with metastatic CRPC who have progressed on abiraterone acetate (Cohort B); and men with metastatic CRPC who have progressed on first line castration-only therapy (Cohort C).

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02090114

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Primary Outcome Measures:

  • Measure: PSA response to Bipolar Androgen Therapy
  • Time Frame: On average at 18 months
  • Safety Issue:
  • Measure: PSA response to enzalutamide or abiraterone acetate post Bipolar Androgen Therapy
  • Time Frame: On average at 24 months
  • Safety Issue:
  • Measure: PSA response to castrate levels of testosterone post Bipolar Androgen Therapy
  • Time Frame: On average at 18 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: PSA progression on enzalutamide or abiraterone acetate or castrate levels post-BAT
  • Time Frame: On average at 18 months
  • Safety Issue:
  • Measure: PSA progression on BAT (Bipolar Androgen Therapy )
  • Time Frame: On average at 18 months
  • Safety Issue:
  • Measure: Measurable disease response
  • Time Frame: On average at 18 months
  • Safety Issue:
  • Measure: Initiation of docetaxel chemotherapy
  • Time Frame: On average at 18 months
  • Safety Issue:
  • Measure: Quality of life
  • Time Frame: On average at 18 months
  • Safety Issue:
  • Measure: Safety and Tolerability
  • Time Frame: On average at 18 months
  • Safety Issue:
  • Measure: Fasting glucose
  • Time Frame: On average at 18 months
  • Safety Issue:
  • Measure: Hemoglobin A1c
  • Time Frame: On average at 18 months
  • Safety Issue:
  • Measure: Fasting insulin
  • Time Frame: On average at 18 months
  • Safety Issue:
  • Measure: Serum C-telopeptide
  • Time Frame: On average at 18 months
  • Safety Issue:
  • Measure: Osteocalcin
  • Time Frame: On average at 18 months
  • Safety Issue:
  • Measure: Bone Scan with SPECT CT
  • Time Frame: On average at 18 months
  • Safety Issue:

Estimated Enrollment: 90

Study Start Date: June 2014

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  1. Performance status ≤2
  2. Age ≥18 years
  3. Histologically-confirmed adenocarcinoma of the prostate
  4. Progressing on continuous androgen ablative therapy (either surgical castration or LHRH agonist).
  5. Documented castrate level of serum testosterone (<50 ng/dl).
  6. For Cohorts A and B, patients must have progressed on prior treatment with enzalutamide or abiraterone acetate + prednisone (by PSA criteria or radiographically).
  7. For castration-only Cohort C, patients must have developed castrate resistant prostate cancer after progressing on first line hormone therapy with either surgical castration or LHRH agonist or LHRH agonist plus an anti-androgen.
  8. Patients progressing on LHRH agonist plus an anti-androgen as first line therapy must be off anti-androgen for 4 weeks prior to first treatment with testosterone.
  9. Patients with rising PSA on two successive measurements at least two weeks apart.
  10. For Cohort A (enzalutamide) and Cohort B (abiraterone acetate):
  11. Prior treatment with up to 2 additional second line hormone therapies, including ketoconazole is allowed.
  12. Patients who have progressed on both enzalutamide and abiraterone acetate are eligible and post-BAT will be retreated with the last second line agent they had received (e.g. patient receiving abiraterone then enzalutamide would receive retreatment with enzalutamide post-BAT).
  13. Patients must be withdrawn from enzalutamide or abiraterone acetate for ≥ 4 weeks and have documented PSA increase after the withdrawal period.
  14. Patients receiving prednisone in conjunction with abiraterone acetate must be weaned off prednisone prior to starting BAT.
  15. For Cohort C (castration-only):
  16. Patients must continue on castrating therapy throughout BAT treatment.
  17. No prior second line hormone treatment with flutamide, bicalutamide, nilutamide, enzalutamide, abiraterone, ketoconazole, ARN-509 or other investigational androgen ablative therapies is permitted for Cohort C.
  18. Prior docetaxel for hormone-sensitive prostate cancer is permitted if ≤ 6 doses were given in conjunction with first-line androgen deprivation therapy and >12 months since last dose of docetaxel.
  19. Acceptable liver function:
  20. Bilirubin < 2.5 times institutional upper limit of normal (ULN)
  21. AST (SGOT) and ALT (SGPT) < 2.5 times ULN
  22. Acceptable renal function: a. Serum creatinine < 2.5 times ULN, OR
  23. Acceptable hematologic status:
  24. Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 (1.5 ×109/L)
  25. Platelet count ≥ 100,000 platelet/mm3 (100 ×109/L)
  26. Hemoglobin ≥ 9 g/dL.
  27. At least 4 weeks since prior surgery with full recovery (no persistent toxicity ≥ Grade 1).
  28. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Pain due to metastatic prostate cancer requiring opioid analgesics.
  2. >5 sites of visceral disease in lung or liver (nonspecific lung nodules ≤1 cm in diameter are permitted).
  3. Prior treatment with docetaxel or cabazitaxel for metastatic castration-resistant prostate cancer is prohibited.
  4. Requires urinary catheterization for voiding due to obstruction secondary to prostatic enlargement thought to be due to prostate cancer or benign prostatic hyperplasia.
  5. Evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone (e.g. femoral metastases with concern over fracture risk, spinal metastases with concern over spinal cord compression, lymph node disease with concern for ureteral obstruction).
  6. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.
  7. Active uncontrolled infection, including known history of AIDS or hepatitis B or C.
  8. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
  9. Prior history of a thromboembolic event within the last two years and not currently on systemic anticoagulation.
  10. Hematocrit >50%, untreated severe obstructive sleep apnea, uncontrolled or poorly controlled heart failure [per Endocrine Society Clinical Practice Guidelines (67)].

Contact:

  • Irina Rifkind, RN, MSN
  • 410-502-2043

Location:

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Baltimore Maryland 21231 United States

View trial on ClinicalTrials.gov


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High Dose Testosterone in Men With Advanced Prostate Cancer and Homologous Recombination Deficiency


Condition: Castration-resistant Prostate Cancer, Homologous Recombination Deficiency

Intervention:

  • Drug: Testosterone Enanthate

Purpose: The purpose of this study is to determine the efficacy of BAT in men with metastatic castrate-resistant prostate cancer (mCRPC) and homologous recombination deficiency (HRD). Bipolar androgen therapy will be administered to men confirmed to have HRD on tumour tissue and/or circulating tumour DNA analysis on pre-screening.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03522064

Sponsor: St Vincent's Hospital, Sydney

Primary Outcome Measures:

  • Measure: PSA Response Rate
  • Time Frame: 1 year
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Time to PSA progression
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Quality of Life
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Radiological Response Rate
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Safety and Tolerability (Frequency of adverse events as assessed by NCI CTCAE v4.0)
  • Time Frame: 1 year
  • Safety Issue:

Estimated Enrollment: 30

Study Start Date: July 30, 2018

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  1. Males with histologically confirmed adenocarcinoma of the prostate
  2. Confirmed HRD (Homologous recombination defect) in germline and/or somatic DNA analysis (tumour or blood), by a validated assay (see Appendix 1). Mutations in HR genes not listed in appendix 1 will be considered in literature suggests pathogenicity. A maximum of 10 uncharacterised or heterozygous mutations will be included.
  3. Age ≥ 18 years
  4. ECOG performance status ≤ 1
  5. Rising PSA confirmed on two sequential tests ≥1 week apart and a minimum value of 2 ug/L despite castrate levels of testosterone
  6. Serum testosterone < 1.7 nmol/L and on an LHRH agent or post orchidectomy ≥ 1 year.
  7. Washout of ≥ 4 weeks from prior line of treatment, radiotherapy or surgery (aside from LHRH agent)
  8. Adequate bone marrow function (platelets > 100 x 109/L, ANC > 1.5 x 109/L, Hb >100)
  9. Adequate liver function (ALT/AST < 1.5 x ULN, bilirubin < 2 x ULN)
  10. Adequate renal function (creatinine clearance > 50 ml/min)
  11. Adequate cardiac function and reserve after cardiology assessment
  12. Archived tissue sample available or willingness to undergo fresh biopsy
  13. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
  14. Signed, written informed consent

Exclusion Criteria:

  1. Contraindications to investigational product
  2. Pain due to metastatic prostate cancer requiring opioid analgesics
  3. Evidence of disease progression in sites or extent that, in the opinion of the investigator, would put the patient at risk from testosterone therapy and its potential for initial tumour flare (eg: femoral metastasis at risk of fracture, ureteric obstruction due to nodal disease or cord compression due to spinal metastases).
  4. Previous treatment with platinum chemotherapy and/or a PARP inhibitor. However up to 8 men with prior treatment to these agents will be included as an exploratory cohort.
  5. Life expectancy of less than 3 months.
  6. Brain metastases or leptomeningeal disease
  7. History of thromboembolic event and not currently on anticoagulation
  8. Prior myocardial infarction or unstable angina within 2 years of study entry
  9. Haematocrit ≥ 50%, untreated severe obstructive sleep apnoea or poorly controlled heart failure (NYHA >1)
  10. History of another malignancy within 5 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 5 years after definitive primary treatment.
  11. Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.
  12. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.

Contact:

  • Robert Kent
  • +61293555611

Location:

  • Kinghorn Cancer Centre, St. Vincent's Hospital
  • Sydney New South Wales 2010 Australia

View trial on ClinicalTrials.gov


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Bipolar Androgen Therapy Plus Olaparib in Patient With Castration-Resistant Prostate Cancer


Condition: Castration Levels of Testosterone, Castration-Resistant Prostate Carcinoma, Prostate Adenocarcinoma, PSA Level Greater Than or Equal to One, PSA Progression

Intervention:

  • Other: Laboratory Biomarker Analysis
  • Drug: Olaparib
  • Other: Quality-of-Life Assessment
  • Other: Survey Administration
  • Drug: Testosterone Enanthate
  • Drug: Testosterone Cypionate

Purpose: This phase II trial studies how well testosterone (enanthate or cypionate) and olaparib work in treating participants with prostate cancer that has progressed despite hormonal therapy. Hormonal therapy, such as leuprolide, may lessen the amount of male sex hormones made by the body. In patients that have developed progressive cancer in spite of standard hormonal treatment (i.e. castration-resistant prostate cancer), administering testosterone may result in regression of tumors by causing DNA damage in cancer cells that have adapted to low testosterone conditions. Olaparib may stop the growth of tumor cells by blocking some of the enzymes involved in repairing DNA damage. Therefore, giving testosterone and olaparib together may work better in treating castration-resistant prostate cancer by generating DNA damage that the cancer cell is unable to repair.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03516812

Sponsor: University of Washington

Primary Outcome Measures:

  • Measure: Percent of patients with a prostate-specific antigen (PSA) decline of at least 50% below baseline PSA50 response rate
  • Time Frame: Up to 12 weeks after initiating therapy
  • Safety Issue:
  • Measure: Incidence of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
  • Time Frame: Up to 30 days after last dose
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Radiographic response rate
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: PSA progression free survival (PFS)
  • Time Frame: From the start of treatment until PSA progression, assessed up to 2 years
  • Safety Issue:
  • Measure: Overall survival (OS)
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: Radiographic PFS
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: PSA50 response rate (i.e. decline in PSA ≥ 50% from baseline)
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: Average change in quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) survey
  • Time Frame: Up to 12 weeks after initiating therapy
  • Safety Issue:
  • Measure: Average change in quality of life (QOL) assessed by the International Index of Erectile Function (IIEF) survey
  • Time Frame: Up to 12 weeks after initiating therapy
  • Safety Issue:

Estimated Enrollment: 30

Study Start Date: August 29, 2018

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Must be willing to provide informed consent prior to any study specific procedures
  • Documented histologically confirmed adenocarcinoma of the prostate
  • Patient must have evidence of castration resistant prostate cancer as evidenced by PSA progression (per Prostate Cancer Working Group 3 [PCWG3] criteria) and a castrate serum testosterone level (i.e., ≤ 50 mg/dL)
  • PSA must be at least 1 ng/ml and rising on two successive measurements at least two weeks apart
  • Patients must have progressed on abiraterone and/or enzalutamide; there must be at least a 3-week washout period after stopping the most recent approved therapy for mCRPC (i.e., abiraterone, enzalutamide, Ra-223, sipuleucel-t); if applicable, patients should be weaned off steroids at least 1 week prior to starting treatment
  • No prior chemotherapy for the treatment of mCRPC; patients may have received docetaxel for the treatment of hormone-sensitive prostate cancer
  • Prior treatment with non-chemotherapy investigational agents is permitted; there must be at least a 3-week washout period after stopping any investigational cancer agent
  • Hemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days (within 28 days prior to administration of study treatment)
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (within 28 days prior to administration of study treatment)
  • Platelet count ≥ 100 x 10^9/L (within 28 days prior to administration of study treatment)
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to administration of study treatment)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be ≤ 5 x ULN (within 28 days prior to administration of study treatment)
  • Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of ≥ 51 mL/min (within 28 days prior to administration of study treatment)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Patients must have a life expectancy ≥ 16 weeks
  • Male patients and their partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for 3 months after last dose of study drug(s) to prevent pregnancy in a partner
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
  • At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by computed tomography (CT), positron-emission tomography (PET), magnetic resonance imaging (MRI) and/or bone scan and is suitable for repeated assessment
  • Must have archival tissue available, be willing to undergo metastatic biopsy or have a sufficient plasma circulating tumor DNA (ctDNA) concentration in order to perform next-generation DNA sequencing
  • The study will require that 50% of enrolled subjects have homozygous deletions, deleterious mutations, or both in one or more of the DNA damage response (DDR) genes; the other 50% of patients must have an intact DDR pathway

Exclusion Criteria:

  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
  • Previous enrollment in this study
  • Participation in another clinical study with an investigational product during the last 3 weeks
  • Any previous treatment with poly-adenosine diphosphate ribose polymerase (PARP) inhibitor, including olaparib
  • Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥ 5 years
  • Resting electrocardiogram (ECG) with corrected QT interval (QTc) > 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome
  • Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
  • Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil); the required washout period prior to starting olaparib is 2 weeks
  • Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil); the required washout period prior to starting olaparib is 3 weeks for enzalutamide, 5 weeks for phenobarbital and 3 weeks for other agents
  • Persistent toxicities (> Common Terminology Criteria for Adverse Event [CTCAE] grade 2) caused by previous cancer therapy, excluding alopecia
  • Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
  • Patients with symptomatic uncontrolled brain metastases; a scan to confirm the absence of brain metastases is not required; the patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment; patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
  • Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery
  • Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection; examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 5 years) myocardial infarction, uncontrolled major seizure disorder, uncontrolled hypertension (blood pressure [BP] ≥ 160/100), stroke within the past 5 years, uncontrolled diabetes (hemoglobin [hgb] A1C > 7), unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent
  • Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication
  • Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)
  • Patients with a known hypersensitivity to olaparib or any of the excipients of the product
  • Patients with a known hypersensitivity to the testosterone cypionate or any of the excipients of the product
  • Patients with known active hepatitis (i.e., hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids
  • Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
  • Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable)
  • Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
  • Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
  • Evidence of disease that, in the opinion of the investigator, would put the patient at risk from testosterone therapy (e.g. femoral metastases with concern over fracture risk, spinal metastases with concern over spinal cord compression, lymph node disease with concern for ureteral obstruction)
  • Patients with pain attributable to their prostate cancer
  • Tumor causing urinary outlet obstruction that requires catheterization for voiding; patients that require catheterization to void secondary to benign strictures or other non-cancer causes will be permitted to enroll
  • Prior history of deep venous thrombosis or pulmonary embolism within 5 years prior to enrollment in the study and not currently on systemic anticoagulation
  • Patients with NYHA (New York Heart Association) class III or IV heart failure or history of a prior myocardial infarction (MI) within the last five years prior to enrollment in the study

Contact:

  • Michael T. Schweizer
  • (206) 288-6252

Location:

  • Fred Hutch/University of Washington Cancer Consortium
  • Seattle Washington 98109 United States

View trial on ClinicalTrials.gov


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COMbination of Bipolar Androgen Therapy and Nivolumab in Patients With Metastatic Castration-Resistant Prostate Cancer


Condition: Castration-resistant Prostate Cancer, Metastatic Prostate Cancer, Prostate Cancer

Intervention:

  • Drug: Testosterone cypionate
  • Drug: Nivolumab

Purpose: Single arm, multicenter, open-label Phase II study of the effects of parenteral testosterone in combination with nivolumab in men with metastatic castration-resistant prostate cancer who previously progressed on at least one novel androgen-receptor targeted therapy (i.e. Abiraterone acetate, Enzalutamide). Up to one taxane agent is permitted.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03554317

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Primary Outcome Measures:

  • Measure: Prostate Specific Antigen (PSA) response to Bipolar Androgen Therapy + Nivolumab
  • Time Frame: 2 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Safety of Bipolar Androgen Therapy + Nivolumab As Determined by the Number of CTCAEs ≥ grade 3
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: PSA Progression-Free Survival (PSA-PFS) to Bipolar Androgen Therapy + Nivolumab
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Progression-Free Survival (PFS) to Bipolar Androgen Therapy + Nivolumab
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Objective Response Rate (ORR) to Bipolar Androgen Therapy + Nivolumab
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Durable Progression-Free Survival (Durable PFS) to Bipolar Androgen Therapy + Nivolumab
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Median Overall Survival (OS) to Bipolar Androgen Therapy + Nivolumab
  • Time Frame: 3 years
  • Safety Issue:

Estimated Enrollment: 44

Study Start Date: September 5, 2018

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Willing and able to provide signed informed consent.
  • Males aged 18 years of age and above.
  • Histological or cytologic proof of adenocarcinoma of the prostate.
  • Known castration-resistant disease, defined according to Prostate Cancer Working Group 3 (PCWG3) criteria as:
  • Castrate serum testosterone level: ≤ 50 ng/dL (≤ 1.7 nmol/L).
  • Subjects who have failed initial hormonal therapy, either by orchiectomy or by using a gonadotropin-releasing hormone (GnRH) agonist in combination with an anti-androgen, must first progress through anti-androgen withdrawal prior to being eligible. The minimum time frame to document failure of anti-androgen withdrawal will be four weeks.
  • Serum Prostate Specific Antigen (PSA) progression defined as two consecutive increases in PSA over a previous reference value within 6 months of first study treatment, each measurement at least one week apart. Or
  • Documented bone lesions by the appearance of ≥ 2 new lesions by bone scintigraphy or dimensionally-measureable soft tissue metastatic lesion assessed by CT or MRI.
  • Absolute PSA ≥ 2.0 ng/mL at screening.
  • Must have PSA and/or radiographic progression on AT LEAST 1 novel AR targeted therapy (abiraterone acetate, enzalutamide). One prior chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC) will be allowed.
  • Prior treatment with abiraterone, enzalutamide, bicalutamide, and/or ketoconazole is allowed. There is no limit on the maximum number or types of prior hormonal therapies received.
  • Must be maintained on a GnRH analogue or have undergone orchiectomy.
  • Radiographic evidence of metastatic disease by CT scan and bone scan, performed within the prior 4 weeks.
  • Must have a soft tissue metastatic lesion available for biopsy collection to perform tumor tissue analysis.
  • Karnofsky Performance Status (KPS): ≥ 70% within 14 days before start of study treatment (ECOG ≤ 2).
  • Participants must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
  • Hemoglobin ≥ 9.0 g/dL with no blood transfusion in the past 28 days.
  • Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Total bilirubin within institutional upper limit of normal (ULN) (In patients with Gilbert's syndrome, total bilirubin < 1.5x institutional ULN will be acceptable).
  • Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) within institutional upper limit of normal.
  • Participants must have creatinine clearance estimated ≥ 40 mL/min.
  • Participants must have a life expectancy ≥ 6 months.
  • Male participants and their partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination, throughout the period of taking study treatment and for 7 months after the last dose of nivolumab to prevent pregnancy in a partner.
  • No evidence (within 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin).

Exclusion Criteria:

  • Has received external-beam radiotherapy within the last 2 weeks prior to start of study treatment.
  • Prior oral anti-androgen (e.g. bicalutamide, nilutamide, enzalutamide, apalutamide), or androgen synthesis inhibitor (e.g. abiraterone, orteronel) within the past 2 weeks is not permitted. 5-alpha reductase inhibitor therapy (e.g. finasteride, dutasteride) is allowed, as long as subject has been stable on medication for past 6 months.
  • Prior treatment with chemotherapy for the treatment of metastatic hormone sensitive prostate cancer is allowed if the last dose of chemotherapy was greater than 6 months prior to enrollment. In addition, one chemotherapy agent for mCRPC will be allowed.
  • Patients who have received prior treatment with bipolar androgen therapy (e.g. testosterone, BAT) are excluded.
  • Pain due to metastatic prostate cancer requiring opioid therapy.
  • Patients with an intact prostate AND urinary obstructive symptoms are excluded (which includes patients with urinary symptoms from benign prostatic hyperplasia (BPH)).
  • Patients receiving anticoagulation therapy with Coumadin are not eligible for study. (Patients on non-coumadin anticoagulants (Lovenox, Xarelto, etc.) are eligible for study. Patients on Coumadin who can be transitioned to Lovenox or Xarelto prior to starting study treatments will be eligible).
  • Patients with prior history of an arteriovenous thromboembolic event within the last 12 months are excluded.
  • Patients allergic to sesame seed oil or cottonseed oil are excluded.
  • Involvement in the planning and/or conduct of the study (applies to both BMS staff and/or staff at the study site).
  • Participation in another clinical study with an investigational product during the last 4 weeks/28 days.
  • Patients should be excluded if they have had prior systemic treatment with an anti-Programmed Cell Death Protein (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-lymphocyte-Associated Protein (CTLA)-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways (e.g. immune checkpoint antagonists).
  • Evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone (e.g. femoral metastases with concern over fracture risk, severe and extensive spinal metastases with concern over spinal cord compression, extensive liver metastases).
  • Concurrent use of other anticancer agents or treatments, with the following exceptions:
  • Ongoing treatment with leutinizing hormone-releasing hormone (LHRH) agonists or antagonists, denosumab (Prolia) or bisphosphonate (e.g. zoledronic acid) is allowed. Ongoing treatment should be kept at a stable schedule; however, if medically required, a change of dose, compound, or both is allowed.
  • Any treatment modalities involving major surgery within 4 weeks prior to the start of study treatment.
  • Symptomatic nodal disease, i.e. scrotal, penile or leg edema (≥ CTCAE Grade 3).
  • Patients are excluded if they have active known brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 4 weeks after treatment is complete and within 28 days prior to the first dose of testosterone administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
  • Patients should be excluded if they have an active, known or suspected autoimmune disease (e.g. inflammatory bowel disease, rheumatoid arthritis, autoimmune hepatitis, lupus, celiac disease). Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
  • Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Permitted therapies include topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if > 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g. contrast dye allergy) or for treatment of non-autoimmune conditions (e.g. delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
  • As there is potential for hepatic toxicity with nivolumab, drugs with a predisposition to hepatotoxicity should be used with caution in patients treated with nivolumab-containing regimen.
  • Patients should be excluded if they have a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
  • Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • History of allergy to study drug components.
  • History of severe hypersensitivity reaction to any monoclonal antibody.
  • Other primary tumor (other than CRPC) including hematological malignancy present within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer).
  • Has imminent or established spinal cord compression based on clinical findings and/or MRI.
  • Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including, but not limited to:
  • Any uncontrolled major infection.
  • Cardiac failure New York Heart Association (NYHA) Class III or IV.
  • Crohn's disease or ulcerative colitis.
  • Bone marrow dysplasia.
  • Known allergy to any of the compounds under investigation.
  • Unmanageable fecal incontinence.
  • Persistent toxicities (> CTCAE Grade 2) caused by previous cancer therapy, excluding alopecia.
  • Poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 6 months) myocardial infarction, uncontrolled major seizure disorder, extensive interstitial bilateral lung disease, or any psychiatric disorder that prohibits obtaining informed consent.

Contact:

  • Michaella Afful, RN
  • 410-502-0017

Location:

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Baltimore Maryland 21231 United States

View trial on ClinicalTrials.gov


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Square Wave Testosterone Therapy in Castration Resistant Prostate Cancer


Condition: Prostate Cancer, Castration-Resistant Prostate Cancer

Intervention:

  • Drug: Transdermal Testosterone
  • Drug: Standard of Care, Enzalutamide

Purpose: This is an open-labeled, single-arm, interventional pilot study. It is being done to determine the feasibility of the administration of transdermal testosterone alternating with enzalutamide, as well as the safety and efficacy.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03734653

Sponsor: University of Colorado, Denver

Primary Outcome Measures:

  • Measure: Feasibility of the Administration of Transdermal Testosterone Alternating with Enzalutamide
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Safety of the Administration of Transdermal Testosterone Alternating with Enzalutamide
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:
  • Measure: Prostate Specific Antigen (PSA) Response Rate
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:
  • Measure: Time to Radiographic Progression
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:
  • Measure: Time to Radiographic Progression
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:
  • Measure: Time to PSA Progression
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:
  • Measure: Maximum Decrease in PSA
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:
  • Measure: Physical Function Change
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:
  • Measure: Physical Function Change
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:
  • Measure: Patient Activation
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:
  • Measure: Reported Fatigue
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:
  • Measure: Patient Mood and Depression Evaluation
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:
  • Measure: Bone Health
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:
  • Measure: Body Composition
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:
  • Measure: Quality of Life Assessment
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:
  • Measure: Change in Hormones
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:
  • Measure: Self-Reported Physical Function
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:
  • Measure: Energy Expenditure
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:
  • Measure: Change in Max Repetition
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:
  • Measure: Change in Spontaneous Physical Activity and Sedentary Time
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:
  • Measure: PSA Response in this Cohort of Patients vs Historical Cohorts
  • Time Frame: Study start date to study end date, up to 12 months, or until patient death
  • Safety Issue:

Estimated Enrollment: 50

Study Start Date: January 18, 2019

Phase: Early Phase 1

Eligibility:

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

Inclusion Criteria:

  • 1. Provision to sign and date the consent form 2. Male and age > 18 years old 3. Stated willingness to comply with all study procedures and be available for the duration of the study 4. Histologically or cytologically proven adenocarcinoma of the prostate 5. Ongoing ADT for prostate cancer with a GnRH analogue/antagonist or bilateral orchiectomy for at least 6 months prior to day 1 6. Patients on a first generation anti-androgen (e.g. bicalutamide, flutamide, nilutamide) must have at least a 6-week washout prior to randomization and must show continued PSA progression 7. Serum testosterone level <50ng/dL at the screening visit 8. Progressive disease at screening as defined by one or more of the following criteria:
  • PSA progression: minimum of 2 rising values within an interval of >1 week between values. And a value at screening of >1ng/mL
  • Soft tissue progression on CT or MRI based on RECIST 1.1 criteria or progression of bone disease according to PCWG3 criteria 9. Asymptomatic or minimally symptomatic prostate cancer (BPI-SF question 3# is <4 and patient not on daily narcotic medications to treat cancer-related pain) 10. Acceptable Clinical laboratory values at Screening Visit which include:
  • Absolute neutrophil count ≥ 1000/uL; platelet count ≥ 100,000/uL, hemoglobin ≥ 8g/dL
  • Total bilirubin ≤ 1.5xULN (unless documented Gilbert's); alanine aminotransferase or aspartate aminotransferase ≤ 2.5xULN
  • Creatinine ≤ 2mg/dL
  • Hemoglobin ≤ 17.5 g/dL 11. Evidence of metastatic disease at any time point on axial imaging or bone scan, or previous biopsy. Stage IV pelvic lymph node involvement is acceptable 12. Must use a condom if having sex with a pregnant woman 13. A male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration 14. Patients may have received any number of lines of therapy for castration resistant disease

Exclusion Criteria:

  • 1. Requires urinary catheterization for voiding due to obstruction secondary to prostatic enlargement that is well documented to be due to prostate cancer or benign prostatic hyperplasia 2. Evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone due to a potential tumor flare (e.g. high-risk bone lesions which may result in fracture or spinal cord compression 3. Clinically significant cardiovascular disease as evidenced by any of the following:
  • Myocardial infarction with 6 months of screening
  • uncontrolled angina within 3 months of screening
  • NYHA class 3 or 4 congestive heart failure
  • clinically significant ventricular arrhythmia
  • Mobitz II/Second degree/or 3rd degree heart block without a pacemaker in place; uncontrolled HTN (systolic >180mmHg or diastolic >105mmHg at screening 4. Previous exposure to enzalutamide 5. Received investigational agent within 2 weeks of screening 6. Therapy with antineoplastic systemic chemotherapy or biological therapy within 2 weeks of screening 7. Radiation therapy within 2 weeks of screening 8. History of a prior malignancy (excluding an adequately treated basal or squamous cell skin cancer, superficial bladder cancer, or a cancer in situ) within 5 years prior to randomization 9. History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agent 10. Known or suspected brain metastasis or active leptomeningeal disease 11. History of seizure at any time in the past. Also, history of loss of consciousness or transient ischemic attack within 12 months of Day 1 visit 12. Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements

Contact:

  • Kerry Scriber
  • 720-848-0656

Location:

  • University of Colorado Hospital
  • Aurora Colorado 80045 United States

View trial on ClinicalTrials.gov


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