AzTrials
AzTrials

Metastatic Prostate CancerPhase 1NCT07145177

177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer

A Phase 1 study testing 177Lu-PSMA-617, Ablation and Trans-arterial chemoembolization (TACE) in people with Metastatic Prostate Cancer and Prostate Cancer, run by University of California, San Francisco at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Metastatic Prostate Cancer, Prostate Cancer
What is being tested?
177Lu-PSMA-617, Ablation and Trans-arterial chemoembolization (TACE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
16 Mar 2026to 31 Oct 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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). Note: Participants without prior bilateral orchiectomy are required to remain on Luteinizing hormone-releasing hormone (LHRH) analogue treatment for duration of study treatment.
  • Prior progression on at least one second generation androgen signaling inhibitor including abiraterone, apalutamide, darolutamide, and/or enzalutamide.
  • Adverse events related to prior anti-cancer treatment (excluding LHRH analogs) must have recovered to Grade ≤ 1 (except for any grade alopecia and grade ≤ 2 neuropathy).
Show all 26Show fewer
  • Prior external beam radiotherapy is allowed if the last radiotherapy treatment was greater than 2 weeks from start of study treatment on Cycle 1 Day 1 (C1D1). Note: Participants must have recovered from all radiation-related toxicities. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
  • At least one PSMA-avid extrahepatic lesion on screening PSMA Positron Emission Tomography (PET). A positive lesion is defined as uptake above background liver. Hepatic lesions may be PSMA PETnegative or positive.
  • Availability of archival mCRPC tissue, or presence of a metastatic lesion that is amenable to fresh biopsy and willingness to undergo biopsy during screening if no archival mCRPC tissue available.
  • The presence of one or more liver metastases amenable to liver-directed therapy in the judgment of the treating interventional radiologist. Liver metastases may be detected by CT or magnetic resonance imaging (MRI), and biopsy confirmation is not required.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 or Karnofsky ≥ 50%.
  • Demonstrates adequate organ function as defined below:
  • Absolute neutrophil count ≥ 1,500/ microliter (mcL).
  • Platelets ≥ 100,000/mcL.
  • Hemoglobin > 9.0 g/dL.
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN). In participants with known or suspected Gilbert's disease, direct bilirubin ≤ ULN.
  • aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) ≤ 5 x institutional upper limit of normal.
  • alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 5 x institutional upper limit of normal.
  • Prothrombin time ≤ 1.5 x institutional upper limit of normal (unless on medical therapy known to prolong prothrombin time).
  • Albumin ≥ 2.8 g/dL
  • Creatinine clearance Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2, calculated using the Cockcroft-Gault equation or 24 hour urine collection.
  • Participants with previously treated brain metastases are eligible provided the following criteria are all met:
  • Last treatment was > 28 days prior to C1D1
  • No evidence of new/progressive brain metastases is observed on MRI obtained during the Screening window
  • Participants must use appropriate methods of contraception during study treatment and for at least 6 months after last study treatment. Note: Participants who are sexually active should consider their female partner to be of childbearing potential if she has experienced menarche and is not postmenopausal (defined as amenorrhea > 24 consecutive months) or has not undergone successful surgical sterilization. Even women who use contraceptive hormones (oral, implanted, or injected), an intrauterine device, or barrier methods (diaphragms, condoms, spermicide) should be considered to be of childbearing potential. Participants who have undergone vasectomy themselves should also be considered to be of childbearing potential. Acceptable methods of contraception include continuous total abstinence, or double barrier method of birth control (e.g., condoms used with spermicide, or condoms used with oral contraceptives). Periodic abstinence and withdrawal are not acceptable methods of contraception.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • De novo small cell neuroendocrine prostate cancer.
  • One or more extrahepatic soft tissue lesions (lymph nodes > 1.5 cm in short axis, visceral/soft tissue lesions > 1 cm) on screening CT that is negative on PSMA PET. Non- PSMA avid liver lesions are allowed.
  • Recipient of other systemic anti-cancer therapies administered within 14 days, or 5 half lives, whichever is shorter, prior to initiation of study treatment. Note: LHRH analogues are the exception and are permitted
  • Recipient of prior PSMA-directed radioligand treatment.
  • Recipient of > 2 lines of prior taxane-based chemotherapy administered in the castration-resistant setting. Prior taxane in the castration sensitive setting does not count towards this limit. If platinum chemotherapy is added to taxane this does not count as a separate line of treatment.
  • Previous bilio-enteric anastomosis, ampulla of Vater sphincterotomy, biliary stent, or biliary drain passing through the ampulla of Vater.
Show all 22Show fewer
  • Currently participating in a study of an investigational therapeutic agent or has used an investigational device within 4 weeks prior to the first dose of study treatment on C1D1. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
  • Clinically significant cardiovascular disease including, but not limited to:
  • Uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure.
  • Uncontrolled angina, history of myocardial infarction, unstable angina, or stroke within 6 months before study entry.
  • Clinically significant arrhythmias not controlled by medication. Note: Chronic rate-controlled or paroxysmal atrial fibrillation/flutter is not an exclusion to study participation.
  • Major surgery within 28 days of study treatment. Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment on C1D1. Minor procedures (e.g., biopsy, cataract surgery, stent placement, endoscopy) are not considered major surgery.
  • Has a secondary malignancy requiring active treatment at study entry (except for carcinoma-in-situ, non-muscle invasive bladder cancer, and non-melanoma skin cancer).
  • Has an active infection requiring intravenous antibiotics within 7 days prior to C1D1.
  • Has a known history of Hepatitis B infection (Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus infection (HCV RNA [qualitative] detected, with the following exceptions:
  • Participants who are HbsAg positive are eligible if they have received hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to study entry.
  • Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening. Participants must have completed curative anti-viral therapy at least 4 weeks prior to study entry.
  • Not a candidate for liver-directed therapy on the basis of any of the following:
  • History of bleeding diathesis and currently on anti-coagulation therapy that cannot be safely discontinued for liver directed therapy.
  • Clinically significant ascites including requiring more than one paracentesis in the 28 days prior to C1D1.
  • Unable or unwilling to follow radiation safety precautions following each dose of radioligand therapy or liver directed therapy.
  • Any condition that, in the opinion of the Principal Investigator, would impair the participant's ability to comply with study procedures.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maya Aslam contact

(415) 514-8987

Maya.Aslam@ucsf.edu

United States1 site, 1 recruiting

  • University of California, San Francisco

    San Francisco, California, 94143

    Maya Aslam, 415-514-8987, Maya.Aslam@ucsf.edu

    877-827-3222, cancertrials@ucsf.edu

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1b Study of 177Lu-PSMA-617 Combined With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To characterize the safety profile of 177Lu-PSMA-617 in combination with liver-directed therapy.

II. To determine the investigator-assessed objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria in patients with mCRPC treated with 177LuPSMA-617 and liver-directed therapy.

SECONDARY OBJECTIVES:

  1. To determine the median radiographic progression-free survival per PCWG3 criteria in patients with mCRPC treated with 177Lu-PSMA-617 and liver-directed therapy.

II. To determine the median overall survival in patients with mCRPC treated with 177Lu-PSMA-617 and liver-directed therapy.

III. To determine the median investigator-assessed duration of objective response per RECIST 1.1 criteria in patients with mCRPC treated with 177Lu-PSMA-617 and liver-directed therapy.

IV. To determine the investigator-assessed hepatic disease response rate (HDRR) per RECIST 1.1 in patients with mCRPC treated with 177Lu-PSMA-617 and liver-directed therapy.

  1. To determine the investigator-assessed hepatic disease control rate (HDCR) at 6 months per RECIST 1.1 in patients with mCRPC treated with 177Lu-PSMA-617 and liver-directed therapy.

VI. To determine the PSA response rate by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria for participants with 50% decline (PSA50) and participants with a 90% decline (PSA90) at any time point on study, as well as individually following each dose of 177Lu-PSMA-617 or liver-directed therapy.

OUTLINE:

Participants will receive treatment with 177Lu-PSMA-617 for up to six total cycles every 6 weeks. Participants with one or more PSMA-negative liver lesions with a single session of liver-directed therapy prior to initiation of study drug. Participants will be follow-up every 3 months up to 5 years after the last study treatment.

Being tested
177Lu-PSMA-617, Ablation, Trans-arterial chemoembolization (TACE), Positron Emission Tomography (PET)/Computerized tomography (CT), Tumor Biopsy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 177Lu-PSMA-617Drug

    Also called Lutetium-177 (177Lu)-PSMA-617

    Given intravenously (IV)

  • AblationProcedure or surgery

    Also called surgical ablation

    Undergo ablation

  • Trans-arterial chemoembolization (TACE)Procedure or surgery

    Also called TACE

    Undergo TACE

  • Positron Emission Tomography (PET)/Computerized tomography (CT)Procedure or surgery

    Also called PET/CT

    Undergo imaging

  • Tumor BiopsyProcedure or surgery

    Also called Biopsy

    Undergo biopsy

  • QuestionnaireOther

    Also called Quality of life questionnaire

    Participant will complete questionnaire

Study groups in NCT07145177
Study groupRoleWhat they receive
Treatment (177Lu-PSMA-617)ExperimentalParticipants with diffusely PSMA-avid disease will receive standard doses of both 177Lu-PSMA-617 (7.4 Gigabequerel (GBq) every 6 weeks for up to 6 cycles) and transarterial chemoembolization (TACE) and/or ablation. Participants with one or more PSMA-negative liver lesions and PSMA-avid disease at all other sites will be treated with a single session of liver-directed therapy (either TACE or ablation) prior to initiation of 177Lu-PSMA-617 treatment. After cycle 2 of 177Lu-PSMA-617, participants who have extrahepatic stable disease/response but hepatic stable disease or progression per RECIST v1.1 will undergo liver-directed therapy. If clinically indicated and extrahepatic disease remains stable after cycle 3 of 177Lu-PSMA-617, participants may undergo a second course of liver-directed therapy. Participants will continue on study until progressive disease, study completion, unacceptable toxicity, or death.
Receives: Drug: 177Lu-PSMA-617; Procedure: Ablation; Procedure: Trans-arterial chemoembolization (TACE); Procedure: Positron Emission Tomography (PET)/Computerized tomography (CT); Procedure: Tumor Biopsy; Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants with treatment emergent adverse events.

    Treatment emergent adverse events will be classified according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events and clinically significant laboratory abnormalities (meeting Grade 3, 4, or 5 criteria according to CTCAE) will be summarized by maximum intensity and relationship to Lu-PSMA-617 and liver-directed therapy (if applicable). Descriptive statistics will be utilized to display the data on toxicity seen. Descriptive summaries of discrete data will present the number of study participants and the incidence as a frequency and a percentage.

    Measured: up to 12 months

  2. Objective response Rate (ORR)

    ORR is defined as the proportion of treated participants who obtained an radiographic objective response [confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Proportion and 95% confidence interval will be reported.

    Measured: up to 12 months

Secondary outcomes (7)

  1. Median radiographic Progression-free survival (rPFS)

    rPFS is defined as the time that elapses between the initiation of trial therapy Cycle 1 Day 1(C1D1) and the date of radiographic disease progression per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria for all evaluable patients. If disease progression or death from any cause is not observed prior to initiating subsequent anti-cancer therapy or completing study participation, the rPFS will be censored as the last available disease assessment. Patients who discontinue treatment for clinical progression or deterioration will be included in the analysis. Calculated based on Kaplan-Meier estimates of rPFS.

    Measured: up to 12 months

  2. Median Overall Survival (OS)

    OS is defined as the overall survival time as the time that elapses between the initiation of trial therapy C1D1 and the date of death from any cause for all evaluable patients. Calculated based on Kaplan-Meier estimates of OS.

    Measured: up to 5 years

  3. Median duration of objective response (mDOR)

    mDOR is defined as the time that elapses between the day of first documented response to trial therapy (confirmed CR or confirmed PR, whichever is first recorded) and subsequent disease progression (per RECIST v1.1 criteria). Results will be calculated based on Kaplan-Meier product limit method.

    Measured: up to 12 months

  4. Hepatic disease response rate (HDRR)

    HDRR is defined as the proportion of treated patients who experience an objective hepatic response [confirmed complete response (CR) or confirmed partial response (PR) per RECIST v1.1criteria.

    Measured: up to 12 months

  5. Hepatic disease control rate (HDCR)

    HDCR is defined as the proportion of treated patients who experience 6 months of hepatic disease control from the day of first documented hepatic response to trial therapy (confirmed CR or confirmed PR, whichever is first recorded) per RECIST v1.1criteria, until hepatic disease progression, change in anti-cancer therapy, or study completion.

    Measured: 6 months

  6. Proportion of Participants With a >=50% Decline in Prostate Specific Antigen (PSA)

    The proportion of participants who achieve greater than 50% decline in baseline PSA (baseline drawn on C1D1), at any point during treatment. Proportion and 95% confidence interval will be reported.

    Measured: up to 15 months

  7. Proportion of Participants With a >=90% Decline in PSA

    The proportion of participants who achieve greater than 90% decline in baseline PSA (baseline drawn on C1D1), at any point during treatment. Proportion and 95% confidence interval will be reported.

    Measured: up to 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2025
  2. Study start16 Mar 2026
  3. Primary completion31 Oct 2028 (estimated)
  4. Study completion31 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07145177
Sponsor's protocol ID
25929
Other IDs
NCI-2025-05994
Status last verified
May 2026
First submitted
20 Aug 2025
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 177Lu-PSMA-617, Ablation and Trans-arterial chemoembolization (TACE) in people with Metastatic Prostate Cancer and Prostate Cancer, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maya Aslam ((415) 514-8987, Maya.Aslam@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with treatment emergent adverse events. (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07145177.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in