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

NCT07150715 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2025-12-17

No results posted yet for this study

Summary

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

  • Oligometastatic Prostate Adenocarcinoma
  • Recurrent Prostate Adenocarcinoma

Interventions

DRUG

Actinium Ac 225 Vipivotide Tetraxetan

Given IV

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Gallium Ga 68 Gozetotide

Given IV

DRUG

Lutetium Lu 177 Vipivotide Tetraxetan

Given IV

PROCEDURE

PSMA PET-CT Scan

Undergo PSMA PET/CT scan

RADIATION

Stereotactic Body Radiation Therapy

Undergo SBRT

Sponsors & Collaborators

Principal Investigators

  • Amar Kishan · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-12
Primary Completion
2030-10-31
Completion
2031-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07150715 on ClinicalTrials.gov