NCT04067570Active, not recruiting
Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer
Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer: A Treatment Feasibility and Outcomes Study
Source: ClinicalTrials.gov · Last updated 18 May 2025
Brief summary (registry, in English)
Radical prostatectomy is a common treatment for localized prostate cancer. More than 30% of men who undergo surgery will subsequently develop recurrence, particularly in patients with adverse features where the risk may be even higher. Recurrence typically manifests as a rise in serum-level of prostate-specific antigen (PSA), referred to as biochemical recurrence. Post-operative radiotherapy is a potentially curative option for many patients, as shown in multiple prior randomized studies. A standard course of post-operative radiation requires 6 to 6 and half weeks of treatment, 5 days a week; however, new high-precision radiation techniques with image guidance, termed stereotactic body radiotherapy (SBRT), can deliver an equivalent or higher dose of treatment in 5 visits. Our group, amongst others, have demonstrated in previous studies, that the new 5-treatment technique was safe, convenient and effective in patients with intact prostates. Currently, limited data exists on this approach after prostatectomy. This study will be one of the first to assess the side effect profile and efficacy of SBRT in patients with localized prostate cancer who are considered candidates for post-prostatectomy radiation.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 21 Aug 2019
- Start date
- 7 Nov 2019
- Primary completion date
- Oct 2030
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT04067570
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 7 Nov 2019 to the primary completion date, Oct 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- • Gross residual disease
- Histological or radiological node +ve (N1) or distant metastases (M1)
- Prior pelvic radiotherapy
- Contraindications to radical pelvic radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)
- Hip prosthesis
Who the study is looking for
- • Histologically confirmed diagnosis of adenocarcinoma of the prostate
- Completed written informed consent
- Able and willing to complete self report questionnaires
- Pathologic stage T3 or T4 (without any gross residual disease), NX-0, M0, and/or +ve surgical margins, and/or a rising PSA post-radical prostatectomy on at least 2 consecutive measurements
Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.