Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT07150715

Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma

Led by Jonsson Comprehensive Cancer Center · Updated on 2025-12-17

107

Participants Needed

1

Research Sites

307 weeks

Total Duration

On this page

Sponsors

J

Jonsson Comprehensive Cancer Center

Lead Sponsor

N

Novartis Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

This phase II trial compares the use of 225Ac-PSMA-617 to 177Lu-PSMA-617, along with stereotactic body radiotherapy for the treatment of prostate cancer that has come back after a period of improvement (recurrent) and that has spread from where it first started (primary site) to multiple other places in the body (oligometastatic). 225Ac-PSMA-617 and 177Lu-PSMA-617 are radioactive drugs. They bind to a protein called a PSMA receptor, which is found on some prostate tumor cells. 225Ac-PSMA-617 or 177Lu-PSMA-617 builds up in these cells and gives off either alpha or beta radiation that may kill them. It is a type of radioconjugate and a type of PSMA analog. Stereotactic body radiation therapy (SBRT) is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving 225Ac-PSMA-617 or 177Lu-PSMA-617 and metastasis directed stereotactic body radiotherapy may be effective in treating patients with recurrent, oligometastatic prostate cancer.

CONDITIONS

Official Title

Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Oligorecurrent prostate cancer with 1-5 asymptomatic lesions outside the prostate or prostate bed identified on PSMA PET/CT
  • Serum testosterone greater than 150 ng/dL
  • Age 18 years or older
  • ECOG performance status of 2 or less
  • No urgent need for radiation therapy
  • Histological confirmation of prostate adenocarcinoma
  • White blood cell count at least 2.5 x 10^9/L
  • Platelets at least 100 x 10^9/L
  • Hemoglobin at least 9 g/dL
  • Total bilirubin less than or equal to 1.5 times the institutional upper limit of normal, or up to 3 times if history of Gilbert's syndrome
  • Alanine aminotransferase or aspartate aminotransferase less than or equal to 3 times the upper limit of normal, or up to 5 times if liver metastases
  • Glomerular filtration rate (creatinine-cystatin C) at least 60 mL/min/1.73m2
  • Serum albumin greater than 3.0 g/dL
  • Patient and partner must use acceptable birth control during the study and for 3 months after last study drug
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Neuroendocrine or small cell carcinoma of the prostate
  • Castrate-resistant prostate cancer (PSA greater than 0.5 ng/mL with serum testosterone less than 150 ng/dL)
  • Androgen deprivation therapy or cytotoxic chemotherapy within 6 months prior to enrollment
  • Concurrent systemic therapy for another solid organ cancer
  • Spinal cord compression
  • Inability to lie flat
  • Known allergy to components of 177Lu-PSMA-617 or 225Ac-PSMA-617
  • Renal function with GFR less than 60 mL/min/1.73m2
  • Total bilirubin above 1.5 times upper limit of normal or above 3 times in Gilbert's syndrome
  • Alanine aminotransferase or aspartate aminotransferase above 3 times upper limit of normal (or above 5 times if liver metastases)
  • De novo oligometastatic disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States, 90095

Actively Recruiting

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Research Team

C

Christy Palodichuk

CONTACT

C

Care Felix

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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