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

Not Applicable

Not yet recruiting

• Conditions: Prostate Cancer Recurrent; Prostate Cancer
• Interventions: Radiation: High Dose Rate Brachytherapy

• Registration Number: NCT06508567
• Lead Sponsor: University Health Network, Toronto

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.

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)

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-07-12
• Study First Posted: 2024-07-18
• Status Verified: 2024-08
• Study Start: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09
• Primary Completion: 2026-03-01
• Study Completion: 2031-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 20

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 < 6 months
5. ECOG 0-2
6. Age > 18 years

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2xHDR Brachytherapy	High Dose Rate Brachytherapy	Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed recurrence after Postoperative Radiotherapy.

Primary Outcome Measures

Name	Time	Method
Dosimetry Parameters	5 Years	As this is a safety and feasibility study, the PTV coverage could be compromised to meet the OAR constraints
Acute toxicity assessed by CTCAE V5.0 (Grade ≥3)	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

Secondary Outcome Measures

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