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New treatment option for Prostate Cancer (Adenocarcinoma)
Official title A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate
ClinicalTrials.gov ID: NCT06844383
What this study is testing
What is Talazoparib with enzalutamide?
Talazoparib with enzalutamide is an investigational medicine, being studied as a potential treatment for prostate cancer (adenocarcinoma).
Also referred to as Talzenna, Xtandi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to find out whether talazoparib in combination with enzalutamide or talazoparib alone delays cancer progression in people with metastatic castration-resistant prostate cancer (mCRPC) who have homologous recombination repair (HRR) mutations and have previously received abiraterone acetate.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Willing and able to provide, or have a legally authorized representative provide, written informed consent and privacy authorization for the release...
- Participants ≥ 18 years of age.
- Are willing to be assigned by chance into either study arm and adhere to the study protocol.
- Ability to swallow study capsules and/or tablets whole.
- Are willing to remain on study treatment and to continue undergoing study imaging despite PSA progression unless clinically deteriorating.
You likely can't join if
- Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study...
- Prior treatment for metastatic or non-metastatic CRPC with an ARPI other than abiraterone acetate with prednisone for ≥ 12 weeks. Prior treatment...
- Participants who received chemotherapy for castration-sensitive prostate cancer are still eligible provided chemotherapy was completed \>6 months...
- Use of investigational agents for the treatment of prostate cancer within 4 weeks of start of study treatment.
- Prior treatment with a PARP inhibitor.
- Concurrent treatment with crizotinib.
See the full eligibility criteria
Who can join
- Willing and able to provide, or have a legally authorized representative provide, written informed consent and privacy authorization for the release of personal health information. A signed informed consent must be...
- Participants ≥ 18 years of age.
- Are willing to be assigned by chance into either study arm and adhere to the study protocol.
- Ability to swallow study capsules and/or tablets whole.
- Are willing to remain on study treatment and to continue undergoing study imaging despite PSA progression unless clinically deteriorating.
- Histological or cytological proof of adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.
- Presence of a pathogenic homologous recombination repair mutation in at least one of the following genes on tumor tissue or circulating tumor DNA testing: BRCA1, BRCA2, ATM (limited to 15% of enrolled participants)...
- Metastatic castration-resistant prostate cancer (mCRPC) as demonstrated by one of the following:
- Metastatic disease documented by conventional imaging: computed tomography (CT)/magnetic resonance imaging (MRI) chest/abdomen/pelvis and bone scan are required to be performed, but metastases do not need to be seen on...
- Unequivocal prostate-specific membrane antigen (PSMA) positron emission tomography (PET) only defined metastatic disease with negative conventional imaging. PSMA PET imaging is not required to be performed, but may be...
- Received prior abiraterone acetate with prednisone for mHSPC or locally advanced disease and on which progressed via a minimum of 2 rising PSA levels with a minimum of a 1-week interval between each determination or...
- Progressive disease at start of treatment and in the setting of medical or surgical castration as defined by 1 or more of the following 4 criteria:
- PSA progression defined as 2 rising PSA levels, above an initial reference value, taken with a minimum of a 1-week interval. If PSA rise is the only indication of progression at start of study treatment, a minimum PSA...
- Soft tissue disease progression as defined by RECIST 1.1.
- Bone disease progression defined by PCWG3 with 2 or more new metastatic bone lesions on a whole-body radionuclide bone scan.
- Appearance of newly identified, convincingly positive lesions consistent with metastatic prostate cancer on PSMA PET.
- Surgically or medically castrated, with testosterone levels of \<50 ng/dL. If the participant is medically castrated, continuous dosing with a gonadotropin-releasing hormone agonist or antagonist must be demonstrated by...
- Eastern Cooperative Oncology Group (ECOG) status of ≤1 (Appendix A: Performance Status Criteria).
- Normal organ function with acceptable initial laboratory values within 14 days of treatment start:
- Absolute neutrophil count ≥ 1,500/µl
- Hemoglobin ≥ 9g/dl
- Platelet count ≥ 100,000/µl
- Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN)
- Potassium ≥ 3.5 mmol/L (within institutional normal range)
- Bilirubin ≤ 1.3 x ULN (unless documented Gilbert's disease)
- Serum glutamic oxaloacetic transaminase/aspartate transaminase (AST) ≤ 2.5 x ULN
- Serum glutamic pyruvic transaminase/ alanine transaminase (ALT) ≤ 2.5 x ULN
- Participants 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 4 months...
What rules you out
- Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable...
- Prior treatment for metastatic or non-metastatic CRPC with an ARPI other than abiraterone acetate with prednisone for ≥ 12 weeks. Prior treatment with abiraterone acetate with prednisone in the mHSPC or locally advanced...
- Participants who received chemotherapy for castration-sensitive prostate cancer are still eligible provided chemotherapy was completed \>6 months prior to start of study treatment.
- Use of investigational agents for the treatment of prostate cancer within 4 weeks of start of study treatment.
- Prior treatment with a PARP inhibitor.
- Concurrent treatment with crizotinib.
- Prior platinum-based chemotherapy for the treatment of prostate cancer.
- Current or planned use of potent P-gp inhibitors within 7 days prior to randomization. The P-gp inhibitors include: amiodarone, carvedilol, clarithromycin, cobicistat, dronedarone, erythromycin...
- Current use of strong cytochrome P450 2C8 (CYP2C8) inhibitors (e.g., clopidogrel, gemfibrozil) and inducers (e.g., rifampin), strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin...
- Participants treated with strong cytochrome P450 2C8 (CYP2C8) inhibitors (e.g., clopidogrel, gemfibrozil) within 7 days from randomization are not eligible.
- Use of hormonal agents with anti-tumor activity against prostate cancer including 5-alpha reductase inhibitors, androgens (e.g., testosterone), cytoproterone acetate, progestational agents, and...
- Use of herbal products or alternative therapies that may decrease PSA levels or that may have hormonal anti-prostate cancer activity (e.g., saw palmetto, PC-SPES, PC-HOPE, St. John's wort, selenium supplements, grape...
- Participants receiving a blood transfusion within 14 days of randomization are not eligible.
- History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma). Also, history of loss of consciousness or transient ischemic attack within 12 months of...
- Medical conditions such as uncontrolled hypertension as indicated by a resting systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 90 mm Hg at screening, uncontrolled diabetes mellitus, and cardiac...
- Untreated known or suspected brain metastases or spinal cord compression or clinically significant malignant epidural disease.
- Use of any prohibited concomitant medications (Appendix C: Medications with the Potential for Drug-Drug Interactions) within 28 days before first dose of study treatment.
- Grade \>2 treatment-related toxicity from prior therapy except alopecia or peripheral neuropathy.
- Known allergy to any of the compounds under investigation.
- Any other condition which, in the opinion of the Investigator, would preclude participation in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Seattle, Washington, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Boston, Massachusetts, United States; Minneapolis, Minnesota, United States; New York, New York, United States; Philadelphia, Pennsylvania, United States; Seattle, Washington, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.