Clinical Trials Logo

Clinical Trial Summary

This is a single-center, open-label, study of Prostate-Specific Membrane Antigen (PSMA)-targeted radionuclide therapy with 177Lu-PSMA-617 in combination with pembrolizumab in participants with metastatic castrate-resistant prostate cancer (mCRPC) who have previously progressed on at least one prior androgen pathway inhibitor (e.g., abiraterone, enzalutamide, apalutamide).

Clinical Trial Description

PRIMARY OBJECTIVE: I. To determine the 12-month radiographic progression-free survival rate per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria in patients with mCRPC treated with pembrolizumab and 177Lu-PSMA-617. SECONDARY OBJECTIVES: I. To determine the median radiographic progression-free survival per RECIST v. 1.1 and PCWG3 criteria in patients with mCRPC treated with pembrolizumab and 177Lu-PSMA-617. II. To determine the objective response rate per RECIST v. 1.1 and PCWG3 criteria in patients with mCRPC treated with pembrolizumab and 177Lu-PSMA-617. III. To determine the median duration of objective response per RECIST v. 1.1 and PCWG3 criteria in patients with mCRPC treated with pembrolizumab and 177Lu-PSMA-617. IV. To determine the greater than 50% decline from baseline PSA (PSA50) and greater than 90% decline from baseline PSA (PSA90) response rate by PCWG3 criteria at any time point on study, as well as individually following each dose of 177Lu-PSMA-617. V. To determine the median time to PSA progression (TTPP) following each dose of 177Lu-PSMA-617 (e.g., TTPP-1, TTPP-2, etc.), as measured by PCWG3 criteria. VI. To determine the median overall survival in patients with mCRPC treated with pembrolizumab and 177Lu-PSMA-617. VII. To characterize the safety profile of the combination of pembrolizumab and 177Lu-PSMA-617 in patients with mCRPC. OUTLINE: Participants will receive one dose of 177Lu-PSMA-617 and may continue treatment for up to six total doses, in the absence of unequivocal clinical progression, or unacceptable toxicity, with minimum interval of 6 weeks between doses. Participants will also receive pembrolizumab and may continue study treatment until unequivocal evidence of clinical progression or at physician's discretion based on clinical evaluation. Participants will undergo safety follow-up visits approximately 30 days following the end of treatment visit. After the last dose/discontinuation of study drug(s), participants will be seen in clinic or contacted by telephone every 3 months after their last treatment date to assess survival/disease/anti-cancer therapy status until death, withdrawal of consent, or the end of the study, whichever occurs first. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05766371
Study type Interventional
Source University of California, San Francisco
Contact UCSF Genitourinary Medical Oncology Recruitment
Phone 877-827-3222
Status Not yet recruiting
Phase Phase 2
Start date April 30, 2023
Completion date April 30, 2028

See also
  Status Clinical Trial Phase
Recruiting NCT05540392 - An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues Phase 1/Phase 2
Recruiting NCT05613023 - A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT Phase 3
Recruiting NCT05156424 - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer Phase 1/Phase 2
Recruiting NCT04081636 - Prostate Biopsy, Transrectal vs. Transperineal: Efficacy and Complications N/A
Completed NCT03177759 - Living With Prostate Cancer (LPC)
Recruiting NCT05540782 - A Study of Cognitive Health in Survivors of Prostate Cancer
Active, not recruiting NCT04742361 - Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer Phase 3
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT02282644 - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry N/A
Recruiting NCT05761093 - Patient Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
Recruiting NCT04838626 - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection Phase 2/Phase 3
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Active, not recruiting NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Recruiting NCT03679819 - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Completed NCT03554317 - COMbination of Bipolar Androgen Therapy and Nivolumab Phase 2
Completed NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A
Recruiting NCT05019846 - SRT Versus SRT+ADT in Prostate Cancer Phase 3
Recruiting NCT04838613 - Study of Diagnostic Performance of [18F]CTT1057 in BCR Phase 3