Actively Recruiting
A Phase 1b Study of 177Lu-PSMA-617 Combined With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer
Led by University of California, San Francisco · Updated on 2026-06-01
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of combining a targeted radionuclide therapy called 177Lu-PSMA-617 with liver-directed treatments in men who have metastatic castration-resistant prostate cancer (mCRPC) with liver metastases. This phase 1b open-label study focuses on patients whose cancer has progressed despite prior androgen pathway inhibitor treatments. The study aims to understand how well this combined approach controls disease and its safety profile using standard response criteria. Participants receive up to six cycles of 177Lu-PSMA-617 intravenously every 6 weeks. Those with PSMA-negative liver lesions receive a single session of liver-directed therapy such as transarterial chemoembolization (TACE) or ablation before starting the radionuclide treatment. If liver disease remains stable or progresses after two cycles, additional liver-directed therapy may be given. Treatment continues until disease progression, unacceptable side effects, or study completion. During the study, participants undergo imaging tests like PET/CT scans, tumor biopsies, and complete questionnaires to assess responses. Researchers monitor safety through adverse event reports and measure outcomes such as objective response rates, progression-free survival, overall survival, and prostate-specific antigen (PSA) declines. Follow-up visits occur every 3 months for up to 5 years after the last treatment to track long-term effects.
CONDITIONS
Brief Title
177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed prostate cancer.
- Progressive disease by PCWG3 criteria at study entry.
- Male participants at least 18 years old.
- Castrate level of serum testosterone (< 50 ng/dL) at study entry; those without prior orchiectomy must remain on LHRH analogue treatment.
- Prior progression on at least one second generation androgen signaling inhibitor such as abiraterone, apalutamide, darolutamide, or enzalutamide.
- Recovery from prior anti-cancer treatment side effects to Grade ≤1 (except alopecia and neuropathy).
- Prior external beam radiotherapy allowed if completed more than 2 weeks before study treatment.
- At least one PSMA-avid extrahepatic lesion on screening PSMA PET.
- Availability of archival mCRPC tissue or willingness to undergo biopsy if no tissue available.
- One or more liver metastases suitable for liver-directed therapy.
- ECOG performance status ≤ 2 or Karnofsky score ≥ 50%.
- Adequate organ function as defined by blood counts, liver and kidney tests.
- Treated brain metastases allowed if last treatment was > 28 days prior and no new brain metastases.
- Use of effective contraception during and for 6 months after treatment.
- Ability and willingness to sign informed consent.
You will not qualify if you...
- De novo small cell neuroendocrine prostate cancer.
- Extrahepatic soft tissue lesions >1.5 cm (lymph nodes) or >1 cm (visceral/soft tissue) on CT that are PSMA PET-negative.
- Systemic anti-cancer therapies within 14 days prior, except LHRH analogues.
- Prior PSMA-directed radioligand treatment.
- More than 2 lines of prior taxane chemotherapy in castration-resistant setting.
- Previous bilio-enteric anastomosis, biliary stent, or drain through ampulla of Vater.
- Participation in another investigational study within 4 weeks prior.
- Significant cardiovascular disease including uncontrolled heart failure, recent heart attack or stroke within 6 months, or uncontrolled arrhythmias.
- Major surgery within 28 days prior unless recovered.
- Secondary malignancy requiring active treatment (except certain skin or bladder cancers).
- Active infection requiring IV antibiotics within 7 days prior.
- Active Hepatitis B or C infection unless treated and undetectable.
- Unsuitable for liver-directed therapy due to bleeding risk or ascites.
- Unable or unwilling to follow radiation safety precautions.
- Any condition impairing ability to comply with study procedures.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session prior to study treatment
Participants with one or more PSMA-negative liver lesions undergo a single session of liver-directed therapy such as transarterial chemoembolization (TACE) or ablation before starting the study drug.
1 visit (in-person)
Duration - Up to 36 weeks (6 cycles every 6 weeks)
Participants receive up to six cycles of 177Lu-PSMA-617 intravenously every 6 weeks. Additional liver-directed therapy sessions may occur after cycle 2 or cycle 3 if clinically indicated based on disease response.
Up to 6 treatment visits every 6 weeks, plus 1 to 2 additional visits for liver-directed therapy if needed
Duration - Up to 5 years
Participants are followed every 3 months for up to 5 years after their last study treatment to monitor their health and disease status.
Quarterly visits for up to 5 years
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
M
Maya Aslam
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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