Recruiting

Brachytherapy

Sponsor:

University Health Network, Toronto

Code:

NCT06508567

Conditions

Prostate Cancer Recurrent

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High Dose Rate Brachytherapy

Study Details

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

Study ID

NCT06508567

Start date

Aug 8, 2024

Status verified date

May, 2026

Completion date

Mar 1, 2031

Anticipated

Primary completion date

Aug 8, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 2xHDR Brachytherapy

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

Interventions

High Dose Rate Brachytherapy

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

Primary outcome measure

  • Dosimetry Parameters [ Time Frame: 5 Years ]
  • Acute toxicity assessed by CTCAE V5.0 (Grade ≥3) [ Time Frame: 5 Years ]

Central Contacts and Locations

Central contacts

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G1Z5

Contacts

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 26, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-05-26.