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Radioligand fOr locAl raDiorecurrent proStaTe cancER

NCT05230251 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-09-12

No results posted yet for this study

Summary

Approximately 50-60% of men undergoing salvage brachytherapy post cancer recurrence to the prostate have the disease controlled at 5 years. This study aims to integrate a local treatment to the prostate (brachytherapy) with a treatment involving 177Lutetium (Lu)- Prostate-Specific Membrane Antigen (PSMA) therapy. Differently than brachytherapy, 177-Lutetium-PSMA is thought to have its effect not only to the cancer cells within the prostate, but also to cancer cells located elsewhere in the body. Thus, the idea here is that by adding 177Lutetium (Lu)- PSMA early in the course of treatment we may be able to inactivate potential metastatic cells outside the prostate, while the prostate cancer within this organ still treated by the combination of brachytherapy and 177-Lutetium-PSMA.

Conditions

Interventions

DRUG

177Lu-PNT2002

Men randomized to receive 177Lu-PSMA will receive 1 cycle of 177Lu-PSMA at a dose of 6.8MBq administered intravenously 2 weeks prior to the planned HDR administration in the Department of Nuclear Medicine as per local practice for the administration of therapeutic radiopharmaceuticals and consistent with good practices.

RADIATION

High Dose Radiation

HDR brachytherapy will be administered as per local practice. All procedures will be conducted under general anesthesia in a dedicated brachytherapy suite using transrectal three dimensional ultrasound for image guidance. For all HDR fractions at least 10Gy will be delivered to the entire prostate with a boost to 13.5Gy to the involved prostate as determined by biopsy and PSMA PET/MRI results. In instances of multi-focal/diffuse involvement of the prostate, the entire prostate will receive 13.5Gy/fraction.

Sponsors & Collaborators

  • London Health Sciences Foundation

    collaborator UNKNOWN

  • Glenn Bauman

    lead OTHER

Principal Investigators

  • Glenn Bauman, MD · London Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-17
Primary Completion
2023-09-25
Completion
2024-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT05230251 on ClinicalTrials.gov