Enzalutamide With Venetoclax in Treating Patients With Metastatic Castration Resistant Prostate C… (NCT03751436) | Clinical Trial Compass
CompletedPhase 1
Enzalutamide With Venetoclax in Treating Patients With Metastatic Castration Resistant Prostate Cancer
United States10 participantsStarted 2019-08-02
Plain-language summary
This phase Ib/II trial studies the side effects and best dose of venetoclax when given together with enzalutamide and to see how well they work in treating patients with castration resistant prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, may lessen the amount of androgens made by the body. Venetoclax may target a special group of prostate cancer cells that is known to lead to resistance to treatment. Giving enzalutamide and venetoclax may work better in treating patients with castration resistant prostate cancer.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histological or cytological documentation of diagnosis of prostate cancer.
* Documented progressive metastatic castrate resistant prostate cancer (mCRPC) based on at least one of the following criteria:
* Prostate specific antigen (PSA) progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng/mL.
* Soft-tissue progression defined as an increase \>= 20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions.
* Progression of bone disease (evaluable disease) or, new bone lesion(s), by bone scan.
* If on an anti-androgen, must have documented progression 6 weeks after stopping anti-androgen therapy.
* Willing to undergo a biopsy, if readily available biopsy site present (i.e., nodal or visceral metastasis).
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
* Have testosterone level of \< 50 ng/dL. Note: Patients must continue primary androgen deprivation with a luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist) if they have not undergone orchiectomy.
* White blood cells \>= 1.5 x 10\^9/L (obtained within 14 days prior to treatment start)
* Platelets (UNVPLT) \>= 100 x 10\^9/L (obtained within 14 days prior to treatment start)
* Hem…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose (MTD) (Phase Ib)
Timeframe: Up to 28 days
2
Recommended phase 2 dose (RP2D) (Phase Ib)
Timeframe: Up to 28 days
3
Progression free survival (Phase II)
Timeframe: Time from start of treatment combination therapy to disease progression, assessed at 12 months