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Compares treatment options for Metastatic Castration-Resistant Prostate Cancer
Official title ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT04986423
What this study is testing
What is ZEN003694?
ZEN003694 is an investigational medicine, being studied as a potential treatment for metastatic castration-resistant prostate cancer.
Also referred to as ZEN-3694.
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
- This is an open-label, randomized, Phase 2b study of ZEN003694 in combination with enzalutamide vs. enzalutamide monotherapy in patients with mCRPC who have progressed on prior abiraterone by PCWG3 criteria.
- 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
- Males age ≥ 18 years
- Metastatic, castration-resistant, histologically confirmed prostate cancer
- Surgical castration or continuous medical castration for ≥ 8 weeks prior to screening; serum testosterone \< 50 ng/dL confirmed within 4 weeks of...
- Have progressed on prior abiraterone treatment by PCWG3 criteria
- Patients who are not candidates for chemotherapy in the opinion of the investigator or patients who decline chemotherapy
You likely can't join if
- Any history of brain metastases, prior seizure, conditions predisposing to seizure activity
- Have previously received an investigational BET inhibitor (including previous participation in this study or a study of ZEN003694)
- Receipt of prior second-generation androgen receptor inhibitors (e.g. enzalutamide, apalutamide, darolutamide, proxalutamide). Receipt of...
- Have received prior chemotherapy in the metastatic castration-resistant setting (prior chemotherapy in the hormone-sensitive setting is allowed...
- Have received prior systemic anti-cancer therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first administration of study...
- Have received exogenous administration of testosterone therapy since discontinuation of abiraterone.
See the full eligibility criteria
- Males age ≥ 18 years
- Metastatic, castration-resistant, histologically confirmed prostate cancer
- Surgical castration or continuous medical castration for ≥ 8 weeks prior to screening; serum testosterone \< 50 ng/dL confirmed within 4 weeks of first administration of study drug
- Have progressed on prior abiraterone treatment by PCWG3 criteria
- Patients who are not candidates for chemotherapy in the opinion of the investigator or patients who decline chemotherapy
- Cohort A only - Patient must meet definition of poor responder to abiraterone by one of the following:
- Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: \< 12 months duration on abiraterone or failure to achieve PSA nadir of 0.2 ng/mL while taking abiraterone
- Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: \< 6 months duration on abiraterone or failure to achieve a PSA50 response
- Cohort B only - Patient must meet definition of responder to abiraterone by one of the following:
- Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: ≥ 12 months duration on abiraterone and nadir PSA \< 0.2 ng/mL
- Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: ≥ 6 months duration on abiraterone and PSA50 response
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Any history of brain metastases, prior seizure, conditions predisposing to seizure activity
- Have previously received an investigational BET inhibitor (including previous participation in this study or a study of ZEN003694)
- Receipt of prior second-generation androgen receptor inhibitors (e.g. enzalutamide, apalutamide, darolutamide, proxalutamide). Receipt of first-generation AR antagonists (e.g. bicalutamide, nilutamide, flutamide) does...
- Have received prior chemotherapy in the metastatic castration-resistant setting (prior chemotherapy in the hormone-sensitive setting is allowed provided last dose was at least 6 months prior to first dose of study drug)
- Have received prior systemic anti-cancer therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first administration of study drug
- Have received exogenous administration of testosterone therapy since discontinuation of abiraterone.
- Failure to recover to Grade 1 or lower toxicity related to prior systemic therapy (excluding alopecia and neuropathy) prior to study entry
- Radiation therapy within 2 weeks of the first administration of study drug
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Whittier, California, United States
- Lakewood, Colorado, United States
- Margate, Florida, United States
- Plantation, Florida, United States
- Baton Rouge, Louisiana, United States
- Columbia, Maryland, United States
- Ann Arbor, Michigan, United States
- New York, New York, United States
- Asheville, North Carolina, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
- Hefei, Anhui, China
- Chongqing, Chongqing Municipality, China
- Xiamen, Fujian, China
- Zhengzhou, Henan, China
+ 9 more site(s).
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 Los Angeles, California, United States; San Francisco, California, United States; Whittier, California, United States; Lakewood, Colorado, United States; Margate, Florida, United States; Plantation, Florida, United States and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.