Pembrolizumab in Metastatic Castration Resistant Prostate Cancer (mCRPC) With or Without DNA Dama… (NCT03248570) | Clinical Trial Compass
CompletedPhase 2
Pembrolizumab in Metastatic Castration Resistant Prostate Cancer (mCRPC) With or Without DNA Damage Repair Defects
United States26 participantsStarted 2018-02-20
Plain-language summary
This is a multicenter phase 2 open label study of pembrolizumab in patients with metastatic castrate resistant prostate cancer (mCRPC) with or without DNA damage repair defects.
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
. Documented histology of adenocarcinoma of the prostate.
. Metastatic castration resistant prostate cancer with castrate-level testosterone (\<50 ng/dL).
. Disease progression defined by one or more of the following three criteria:
. Prostate-specific antigen (PSA) \> 2.0 ng/mL and rising PSA by at least 2 consecutive measurements a minimum of 1-week apart.
. Soft tissue progression as defined by RECIST v1.1 criteria.
. Bone disease progression as defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG3).
. Have received prior secondary hormonal therapy including abiraterone, enzalutamide and/or apalutamide.
. Be taking prednisone at a dose of ≤ 10mg/day, 7 days prior to starting treatment (Cycle 1, Day 1).
Exclusion criteria
. Significant liver metastasis.
. Prior taxane-based chemotherapy with progressive disease on chemotherapy.
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
Radiographic Progression-Free Survival Rate (rPFS) at 6 Months
Timeframe: Up to 6 months
2
Median Overall Radiographic Progression-free Survival (rPFS)
. Prior docetaxel for metastatic hormone sensitive prostate cancer is allowed, if no progression of disease on docetaxel as defined by RECIST v1.1 and PCWG3.
. Prior taxane-based chemotherapy (i.e. docetaxel or cabazitaxel with or without platinum agent) for mCRPC is allowed if no progression of disease on chemotherapy as defined by RECIST v1.1 and PCWG3.
. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy \>10mg/day or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
. Has a known history of active Bacillus Tuberculosis (TB).
. Hypersensitivity to pembrolizumab or any of its excipients.