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Recruiting NCT06508567

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

No phase Interventional Prostate Cancer Recurrent Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High Dose Rate Brachytherapy.
Who it may be relevant to
Registry conditions: Prostate Cancer Recurrent, Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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)

Interventions

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

Primary outcome measures

  • Dosimetry Parameters [Time frame: 5 Years]
  • Acute toxicity assessed by CTCAE V5.0 (Grade ≥3) [Time frame: 5 Years]
Secondary outcome measures (3)
  • Biochemical Control assessed by PSA [Time frame: 5 Years]
  • Local Disease Control [Time frame: 2 Years]
  • Changes in Quality of Life [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Princess Margaret Cancer Centre — Toronto

Identifiers

NCT: NCT06508567 · 23-6023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗