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

Conditions

• Oligometastatic Prostate Adenocarcinoma
• Recurrent Prostate Adenocarcinoma

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Actinium Ac 225 Vipivotide Tetraxetan — DRUG
  Given IV
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Gallium Ga 68 Gozetotide — OTHER
  Given IV
• Lutetium Lu 177 Vipivotide Tetraxetan — DRUG
  Given IV
• PSMA PET-CT Scan — PROCEDURE
  Undergo PSMA PET/CT scan
• Stereotactic Body Radiation Therapy — RADIATION
  Undergo SBRT

Study Details

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.

Key Dates

Start date

Dec 12, 2025

Status verified

Dec 2025

Primary completion

Oct 31, 2030

Completion

Oct 31, 2031

Study Design

Enrollment

107 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (177Lu-PSMA-617)
  Patients receive 177Lu-PSMA-617 IV, over 1-10 minutes, on day one of each cycle. Cycles repeat every 6 weeks for 2 cycles. 4-6 weeks after completion of 177Lu-PSMA-617 patients receive 68Ga-PSMA-11 IV and undergo PSMA PET/CT scan. Within 4 weeks of the scan, patients receive SBRT, for 1-5 treatments, over 1- 1- days. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo PSMA PET/CT scan and blood sample collection throughout the study.
• Experimental: Arm II (225Ac-PSMA-617)
  Patients receive 225Ac-PSMA-617 IV once. 4-6 weeks after completion of 225Ac-PSMA-617 patients receive 68Ga-PSMA-11 IV and undergo PSMA PET/CT scan. Within 4 weeks of the scan, patients receive SBRT, for 1-5 treatments, over 1- 1- days. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo PSMA PET/CT scan and blood sample collection throughout the study.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: From the date of randomization to the date of disease progression or death, whichever happens earlier, up to 5 years ]

Central Contacts

• Christy Palodichuk
  3107942971
  [email protected]
• Care Felix
  310-825-9771
  [email protected]

Locations (1)

Find similar trials in Los Angeles, CA

Related Studies

• SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma
  PHASE3 · Recruiting · Mayo Clinic · Scottsdale, Arizona