Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT06288113
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Castration-Resistant Prostate Carcinoma
  • Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex
MALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo PET/CT and SPECT/CT
  • Gallium Ga 68 Gozetotide — OTHER
    Given IV
  • Lutetium Lu 177 Vipivotide Tetraxetan — DRUG
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Single Photon Emission Computed Tomography — PROCEDURE
    Undergo SPECT/CT

Study Details

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.

Key Dates

Start date
Aug 1, 2024
Status verified
Mar 2026
Primary completion
Jan 27, 2027
Completion
Jan 27, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095
Ethan Lam
[email protected]
310-206-7372
Stephanie Lira
[email protected]
3102060596
Jeremie Calais (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CA

Related Studies