Recruiting
Phase 2

177Lu-PSMA-617

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT06288113

Conditions

Castration-Resistant Prostate Carcinoma

Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Computed Tomography

Gallium Ga 68 Gozetotide

Lutetium Lu 177 Vipivotide Tetraxetan

Positron Emission Tomography

Study Details

Brief summary:

This phase II trial tests how well re-treatment with 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic), that continues to grow or spread after the surgical removal of the testes or medical treatment to block androgen production (castration-resistant), and that has shown a favorable response to initial treatment with 177Lu-PSMA-617. 177Lu-PSMA-617 is a radioactive drug. It binds to a protein called prostate specific membrane antigen (PSMA), which is expressed by some types of prostate tumor cells. When 177Lu-PSMA-617 binds to PSMA-expressing tumor cells, it delivers radiation to the cells, which may kill them. Re-treatment with 177Lu-PSMA-617 in patients who had a favorable response to initial 177Lu-PSMA-617 treatment may improve survival outcomes and disease response in patients with metastatic castration-resistant prostate cancer.

Conditions

Castration-Resistant Prostate Carcinoma

Stage IVB Prostate Cancer AJCC v8

Study ID

NCT06288113

Start date

Aug 1, 2024

Status verified date

Mar, 2026

Completion date

Jan 27, 2028

Anticipated

Primary completion date

Jan 27, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must have mCRPC
  • Patients must have received at least one regimen of chemotherapy for mCRPC
  • Patients must have received at least one androgen receptor signaling inhibitor (ARSI)
  • Patients must have previously completed at least 4 cycles of 177Lu-PSMA-617 therapy
  • Patients must have had a favorable response to the first regimen of 177Lu-PSMA-617 therapy defined as:

  • PSA decline of ≥ 50% at any time during the first regimen of 177Lu-PSMA-617 therapy AND
  • No new prostate cancer therapy within two months of completing the first regimen of 177Lu-PSMA-617 therapy (first-generation androgen deprivation therapy \[ADT\] is allowed). Concomitant prostate cancer therapy that was administrated during the first regimen of 177Lu-PSMA-617 therapy and continued afterwards is allowed
  • Patients must have had a PSA increase after the first regimen of 177Lu-PSMA-617 therapy, confirmed by a second measurement ≥ 3 weeks apart
  • Patients must meet PSMA PET/CT VISION criteria. PSMA PET/CT must have been completed within 8 weeks of the planned first cycle of re-challenge 177Lu-PSMA-617 therapy and at least 6 weeks after completion of the first regimen of 177Lu-PSMA-617 therapy
  • White blood cells > 2,500 cells/µL
  • Absolute neutrophil count > 1,500 cells/µL
  • Hemoglobin > 9.0 g/dL
  • Platelets > 100,000 cells/µL
  • Patients must have the ability to understand and sign an approved informed consent form (ICF) and comply with all protocol requirements

Exclusion Criteria:

  • Patient received new prostate cancer therapy within two months of completing the first regimen of 177Lu-PSMA-617 therapy (first-generation ADT (adenosine triphosphate) is allowed). This can include apalutamide, enzalutamide, abiraterone, chemotherapy, immunotherapy, radionuclide therapy, PARP inhibitor, or any biological therapy. Concomitant prostate cancer therapy that was administrated during the first regimen of 177Lu-PSMA-617 therapy and continued afterwards is allowed
  • Patient received myelosuppressive therapy (including docetaxel, cabazitaxel, 223Ra, and 153Sm) or other radionuclide therapy within the last 6 weeks
  • Patient with creatinine clearance < 50 mL/min

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (177Lu-PSMA-617)

Patients receive 177Lu-PSMA-617 IV on day 1 of each cycle. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive gallium Ga 68 gozetotide IV and undergo PET/CT at screening and on study, undergo SPECT/CT on study, and undergo collection of blood samples throughout the trial.

Interventions

Biospecimen Collection

Undergo collection of blood samples

Computed Tomography

Undergo PET/CT and SPECT/CT

Gallium Ga 68 Gozetotide

Given IV

Lutetium Lu 177 Vipivotide Tetraxetan

Given IV

Positron Emission Tomography

Undergo PET/CT

Questionnaire Administration

Ancillary studies

Single Photon Emission Computed Tomography

Undergo SPECT/CT

Primary outcome measure

  • 12-month overall survival [ Time Frame: Assessed at 12 months ]

Central Contacts and Locations

Central contacts

Stephanie Lira

3102060596StephanieLira@mednet.ucla.edu

Ethan Lam

3102067372clam@mednet.ucla.edu

Locations

UCLA / Jonsson Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Ethan Lam

310-206-7372clam@mednet.ucla.edu

Stephanie Lira

3102060596StephanieLira@mednet.ucla.edu

Principal Investigator:

Jeremie Calais

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2026-03-13.