Recruiting
Phase 1

177Lu-PSMA

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT05398302

Conditions

Castration-Resistant Prostate Carcinoma

Metastatic Prostate Carcinoma

Stage IV Prostate Cancer American Joint Committee on Cancer (AJCC) v8

Stage IVA Prostate Cancer AJCC v8

Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Image Guided Biopsy

Study Details

Brief summary:

This clinical trial studies mechanisms of resistance to 177-lutetium prostate specific membrane antigen (177Lu-PSMA) radioligand therapy using image-guided biopsies in patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). Diagnostic procedures, such as image guided biopsies, may help in learning how well 177Lu-PSMA works to kill tumor cells and allow doctors to plan better treatment.

Conditions

Castration-Resistant Prostate Carcinoma

Metastatic Prostate Carcinoma

Stage IV Prostate Cancer American Joint Committee on Cancer (AJCC) v8

Stage IVA Prostate Cancer AJCC v8

Stage IVB Prostate Cancer AJCC v8

Study ID

NCT05398302

Start date

Apr 26, 2024

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Volunteer patient
  • Histologically confirmed prostate cancer
  • Eligible for 177Lu-PSMA-617 under expanded access protocol (IRB# 21-5010) or as part of an approved trial
  • Based on positron emission tomography (PET)/computed tomography (CT) images: Evidence of lymph node or soft tissue metastatic disease amenable to image-guided biopsy
  • Platelets > 75,000/ul within 14 days prior to biopsy
  • Prothrombin time (PT) or International normalized ratio (INR) and a partial thromboplastin time (PTT) < 1.5 times the institutional upper limit normal (ULN) within 14 days prior to biopsy
  • Patients on warfarin, aspirin, or other anti-coagulants are eligible provided they are deemed able to tolerate discontinuation of anti-coagulation for one week prior to the biopsy. Conversion to low molecular weight heparin prior to biopsy is permitted per local standard operating procedures, provided there is agreement regarding the procedure between the treating physician, the interventional radiologist and the principal investigator (PI)

Exclusion Criteria:

  • Patients with significant congenital or acquired bleeding disorders (e.g. von Wildebrand's disease, acquired bleeding factor inhibitors) are not eligible

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic (image-guided biopsy)

Patients undergo an image-guided biopsy at baseline and 2-4 weeks after cycle 2 of 177Lu-PSMA-617 therapy.

Interventions

Image Guided Biopsy

Undergo image-guided biopsy

Primary outcome measure

  • Proportion of patients with a successful evaluable biopsy with molecular and cellular alterations after radioligand therapy (RLT) [ Time Frame: At the end of cycle 2 before the initiation of cycle 3 of RLT (cycle is six weeks) ]

Central Contacts and Locations

Central contacts

Ankush Sachdeva

310-794-3421asachdeva@mednet.ucla.edu

Locations

UCLA / Jonsson Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Ankush Sachdeva

310-794-3421asachdeva@mednet.ucla.edu

Principal Investigator:

Johannes Czernin, MD

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Jun 15, 2026

Last verified

May, 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 2026-06-15.