🏛️ Verified NIH Record • Updated 2026-05-18
Sacituzumab Govitecan in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy (NCT03725761)
🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: University of Wisconsin, Madison
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (23 items) and avoid the listed exclusions (16 items).
Location: Memorial Sloan-Kettering Cancer Center — New York, New York
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Received prior cytotoxic chemotherapy such as docetaxel, cabazitaxel or platinum chemotherapy for metastatic prostate cancer, castration sensitive or castration resistant, within two years prior to study entry. Neoadjuvant chemotherapy is allowed.
- Completed sipuleucel-T (Provenge ®) treatment within 30 days of study treatment start.
- Received any therapeutic investigational agent within 2 weeks of study treatment start.
- Received palliative radiotherapy within 4 weeks of study treatment start.
- Received 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 seed extract, etc.) within 4 weeks of study treatment start or plans to initiate treatment with these products/alternative therapies during the entire duration of the study.
- Active central nervous system (CNS) metastases from prostate cancer. Subjects with treated epidural disease are eligible to enroll. Subjects with treated brain metastases can be included as long as \>4 weeks have elapsed since last treatment (radiotherapy or surgery) for brain metastases, the subject is neurologically and radiographically stable, and is not receiving corticosteroids for brain metastases. Subjects with untreated brain metastases are excluded. Brain imaging (CT or MRI) is not required at baseline if brain metastases are not clinically suspected.
- A history within the last 3 years of another invasive malignancy (excluding non-melanoma skin cancer).
- A QTcF interval of \>470 msec on the initial Screening ECG; if the Screening ECG QTcF interval is \>470 msec, then it may be repeated two more times, and if the mean QTcF of the 3 ECGs is ≤470 msec, the subject may be enrolled.
- A history of clinically significant cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsades de pointes and second degree or third degree atrioventricular heart block without a permanent pacemaker in place. Subjects with resolved or rate-controlled atrial fibrillation/atrial flutter are allowed.
- NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction/acute coronary syndrome within the preceding 6 months.
- Diabetes mellitus with more than 2 episodes of diabetic ketoacidosis in the 12 months preceding study treatment start.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (3 Sites)
- Memorial Sloan-Kettering Cancer Center — New York, New York
- Weill Cornell Medical College — New York, New York
- University of Wisconsin Carbone Cancer Center — Madison, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.