Recruiting

PSMA Radioligand Therapy

Sponsor:

UCLA

Code:

NCT05435495

Conditions

Prostate Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Single-photon emission computed tomography

Blood Draw

Tumor Biopsy

Study Details

Brief summary:

This is a multicenter, correlative study to existing Lutetium based prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) trials and uses.

Conditions

Prostate Cancer

Study ID

NCT05435495

Start date

Oct 21, 2021

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Initiating treatment with Lutetium based PSMA-targeted RLT.
2. Participants must have a PSMA-avid lesion that is accessible to biopsy. Biopsy of newly emerging radiographic metastases is desired and preferable to the biopsy of previously existing lesions whenever possible. Newly emerging lesions are defined as those that are absent on a previous scan, or those demonstrating unequivocal progression since initiation of the last treatment. Biopsies will be performed according to local institutional standards.
3. Patients on warfarin, aspirin, or other anti-coagulants are eligible provided they are deemed able to tolerate discontinuation of anti-coagulation for at least five days prior to the biopsy. Conversion to low molecular weight heparin prior to biopsy is permitted per local standard operating procedures, provided there is approval by the interventional radiologist or the PI.
4. Age >=18 years.
5. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients with significant congenital or acquired bleeding disorders (eg von Wildebrand's disease, acquired bleeding factor inhibitors).
2. Patients who are not able to undergo additional study related imaging procedures.

Study Design

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants undergoing 177Lu-PSMA-617 treatment

Participants undergoing PSMA targeted radioligand therapy with at least four cycles of treatment planned will undergo the following: SPECT/CTs will be performed 24 hours after the first treatment and after the fourth treatment, a tumor biopsy will be performed prior to the first 177Lu-PSMA radioligand therapy, a blood will be drawn prior to treatment for future research, and an optional tumor biopsy and blood draw for future research, may also be obtained at time of progression.

Interventions

Single-photon emission computed tomography

Imaging procedure

Blood Draw

Blood draw for future research tests (45-60 mL).

Tumor Biopsy

Guided biopsy of lesion

Primary outcome measure

  • Mean whole body tumor absorbed dose (WB Dose) across all metastatic lesions [ Time Frame: Up to 6 months ]
  • Median PORTOS score [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Principal Investigator:

Johannes Czernin, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Thomas Hope, MD

Memorial Sloan Kettering

Recruiting

New York, New York, United States, 10065

Principal Investigator:

Lisa Bodei, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

  • Radioligand Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-03-18.