Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era (SHAPE-PSMA)

May 21, 2026 updated by: University Health Network, Toronto
This is an interventional, single-centre, single-arm, non-randomized, prospective, feasibility trial investigating salvage MR-guided High-Dose-Rate brachytherapy for prostate bed recurrence after postoperative radiotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients who received previous adjuvant or salvage radiotherapy to the prostate bed >

Isolated prostate bed recurrence based on PSMA PET, biopsy-proven, and MR visible >

Baseline: QoLs questionnaires, PSA, pelvic magnetic resonance imaging (MRI) scan for RT planning >

Two fractions of 13 Gy each delivered over 7-21 days. GTV(HDR) delineation (based on MRI-guided and PSMA PET, biopsy data as applicable) >

Follow-Up after treatment 60 months: PSA, CTCAE v5.0, MRI pelvis +/- PSMA-PET scan (optional at 24 months)

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1Z5
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients who received previous RT to the prostate bed +/- pelvic nodal regions
  2. Prostate-bed recurrence identified by biopsy and/or MRI and/or PSMA-PET scan
  3. At least two continuous PSA elevations post RT and PSA above 0.2 ng/dl
  4. With or without ADT PSA doubling time from nadir greater than 6 months
  5. ECOG 0-2
  6. Age greater than 18 years

Exclusion Criteria:

  1. Radiological (e.g. PSMA PET, CT, MRI or bone scan) evidence of or distant metastases
  2. History of ≥G3 gastrointestinal (GI) and genitourinary (GU) toxicities following RT
  3. Any contraindications to MR and/or brachytherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2xHDR Brachytherapy
Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed recurrence after Postoperative Radiotherapy.
Radiation: High Dose Rate Brachytherapy
2 fractions of MRI-guided HDR Brachytherapy (13Gy each) delivered over 14 days (± 7 days).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dosimetry Parameters
Time Frame: 5 Years
As this is a safety and feasibility study, the PTV coverage could be compromised to meet the OAR constraints
5 Years
Acute toxicity assessed by CTCAE V5.0 (Grade ≥3)
Time Frame: 5 Years
Determine the number of patients with late genitourinary, gastrointestinal and/or sexual toxicities as a result of salvage HDR Brachytherapy treatment at a grade ≥3
5 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical Control assessed by PSA
Time Frame: 5 Years
Determine the number of patients demonstrating biochemical control of PSA following salvage HDR Brachytherapy treatment.
5 Years
Local Disease Control
Time Frame: 2 Years
Assessed by MRI/PSMA-PET imaging at 2 years
2 Years
Changes in Quality of Life
Time Frame: 5 years
Assessed with EPIC Quality of Life scores yearly for 5 years.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2024

Primary Completion (Estimated)

August 8, 2026

Study Completion (Estimated)

March 1, 2031

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

July 12, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-6023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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