Sacituzumab Govitecan in Patients With Metastatic Castration-Resistant Prostate Cancer Progressin… (NCT03725761) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Sacituzumab Govitecan in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy
United States31 participantsStarted 2018-10-24
Plain-language summary
This study will investigate the safety and efficacy of Sacituzumab Govitecan in patients with metastatic castration-resistant prostate cancer progressing on second generation androgen receptor (AR) directed therapy (e.g., enzalutamide, darolutamide, apalutamide and/or abiraterone).
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 histological or cytological evidence of adenocarcinoma of the prostate
* Documented metastatic disease on bone scan and/or CT scans
* Currently receiving enzalutamide, darolutamide, apalutamide and/or abiraterone. Subjects who have received combination enzalutamide/abiraterone or combination apalutamide/abiraterone as part of clinical trials are allowed but will need to be receiving only a single agent ARSI at the time of study enrollment. Subjects who have received any other therapeutic investigational product directed towards the AR or androgen biosynthesis are allowed. Prior treatment with first-generation AR antagonists (i.e., bicalutamide, nilutamide, flutamide) before second generation AR-directed therapy is allowed.
* Demonstrated disease progression while on enzalutamide, darolutamide, apalutamide, and/or abiraterone. Progressive disease is defined by one or more of the following:
* A rise in prostate specific antigen (PSA) on two successive determinations at least one week apart and PSA level ≥2 ng/mL
* Soft-tissue progression defined by RECIST 1.1
* Bone disease progression defined by Prostate Cancer Working Group 2 (PCWG2) with ≥2 new lesions on bone scan
* A minimum serum PSA level of ≥2 ng/mL that is rising based on the PCWG2 criteria
* ≥18 y ears of age
* Castrate levels of testosterone (\<50 ng/dL \[1.74 nmol/L\])
* Undergone orchiectomy, or have been on Luteinizing hormone-releasing hormone (LHRH) agonists or antagonist…
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.