Actively Recruiting
177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer
Led by University of California, San Francisco · Updated on 2026-03-23
30
Participants Needed
1
Research Sites
241 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
This is an open label, single arm, phase 1b study to determine the safety of combining sequential Prostate-Specific Membrane Antigen (PSMA)-targeted 177Lu-PSMA-617 radionuclide therapy with liver-directed therapy in metastatic castrate-resistant prostate cancer (mCRPC) patients with liver metastases amenable to liver-directed therapy who have progressed on at least one prior androgen pathway inhibitor.
CONDITIONS
Official 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 who are at least 18 years of age on the day of signing informed consent.
- Castrate level of serum testosterone at study entry (< 50 ng/dL). Participants without prior bilateral orchiectomy must remain on LHRH analogue treatment during the study.
- Prior progression on at least one second generation androgen signaling inhibitor (abiraterone, apalutamide, darolutamide, and/or enzalutamide).
- Recovery from adverse events related to prior anti-cancer treatment to Grade ≤ 1 (except alopecia and Grade ≤ 2 neuropathy).
- Prior external beam radiotherapy allowed if last treatment was > 2 weeks before study treatment start and participant recovered from radiation toxicities.
- At least one PSMA-avid extrahepatic lesion on screening PSMA PET; liver lesions may be PSMA PET-negative or positive.
- Availability of archival mCRPC tissue or willingness to undergo biopsy if no archival tissue available.
- Presence of one or more liver metastases amenable to liver-directed therapy.
- ECOG performance status ≤ 2 or Karnofsky score ≥ 50%.
- Adequate organ function as defined by specific blood counts, liver and kidney function tests.
- Participants with treated brain metastases eligible if last treatment > 28 days prior and no new/progressive brain metastases on MRI.
- Use of appropriate contraception during and for 6 months after study treatment.
- Ability to understand and willingness to sign informed consent.
You will not qualify if you...
- De novo small cell neuroendocrine prostate cancer.
- One or more extrahepatic soft tissue lesions > lymph nodes 1.5 cm or visceral/soft tissue lesions > 1 cm on CT that are PSMA PET-negative; non-PSMA avid liver lesions allowed.
- Receipt of other systemic anti-cancer therapies within 14 days or 5 half-lives before study treatment, except LHRH analogues.
- Prior PSMA-directed radioligand treatment.
- More than 2 prior lines of taxane-based chemotherapy in the castration-resistant setting.
- Previous bilio-enteric anastomosis, ampulla of Vater sphincterotomy, biliary stent, or biliary drain through ampulla.
- Participation in another investigational study within 4 weeks prior to first dose.
- Clinically significant cardiovascular disease including uncontrolled heart failure, recent myocardial infarction, unstable angina, stroke within 6 months, or uncontrolled arrhythmias.
- Major surgery within 28 days before study treatment without adequate recovery.
- Secondary malignancy requiring active treatment except certain low-risk cancers.
- Active infection requiring intravenous antibiotics within 7 days before study treatment.
- Known active Hepatitis B or C infections unless controlled with antiviral therapy.
- Not a candidate for liver-directed therapy due to bleeding disorders, anticoagulation, or significant ascites.
- Unable or unwilling to follow radiation safety precautions.
- Any condition impairing ability to comply with study procedures as judged by investigator.
AI-Screening
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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
CONTACT
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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