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NCT Number: NCT06508567

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

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.

Recruiting

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Key information

Conditions

Prostate Cancer Recurrent Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G1Z5, Canada

Location status: Recruiting

Location contact

Peter Chung

CONTACT

[email protected]

416-946-4501 ext. 3374

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High dose rate brachytherapy

Radiation

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Biochemical Control assessed by PSA

    Time frame: 5 Years

    Determine the number of patients demonstrating biochemical control of PSA following salvage HDR Brachytherapy treatment.

  2. Local Disease Control

    Time frame: 2 Years

    Assessed by MRI/PSMA-PET imaging at 2 years

  3. Changes in Quality of Life

    Time frame: 5 years

    Assessed with EPIC Quality of Life scores yearly for 5 years.

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Chung, MD

CONTACT

[email protected]

416-946-4501 ext. 3374

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Acronym: SHAPE-PSMA

Important dates

Study start
2024
Primary completion
2026
Study completion
2031
First posted
Jul 18, 2024
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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