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

NCT06508567 | Recruiting

• 1 other identifier: 23-6023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer Recurrent; Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Dosimetry Parameters

  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)

  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 Outcomes (3)

• Biochemical Control assessed by PSA

  5 Years

• Local Disease Control

  2 Years

• Changes in Quality of Life

  5 years

Study Arms (1)

2xHDR Brachytherapy

EXPERIMENTAL

Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed recurrence after Postoperative Radiotherapy.

Radiation: High Dose Rate Brachytherapy

Interventions

High Dose Rate Brachytherapy RADIATION

2 fractions of MRI-guided HDR Brachytherapy (13Gy each) delivered over 14 days (± 7 days).

2xHDR Brachytherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G1Z5, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Peter Chung, MD

CONTACT

416-946-4501; peter.chung@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: July 18, 2024
• Study Start: August 8, 2024
• Primary Completion (Estimated): August 8, 2026
• Study Completion (Estimated): March 1, 2031
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

CA (1)