Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer

Not Applicable

Active, not recruiting

• Conditions: Radical Prostatectomy; SBRT
• Interventions: Radiation: SBRT

• Registration Number: NCT04067570
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-21
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-26
• Study Start: 2019-11-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2030-10
• Study Completion: 2030-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• • 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

Exclusion Criteria

• • 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SBRT post operative	SBRT	Stereotactic Body Radiotherapy (SBRT) 30 Gy in 5 fractions, once weekly to prostate bed * / - 25 Gy in 5 fractions, once weekly simultaneously to pelvic lymph nodes * / - 6-24 months of androgen deprivation therapy (ADT)

Primary Outcome Measures

Name	Time	Method
Acute genitourinary (GU) and gastrointestinal (GI) toxicities	Through accrual completion, up to 3 years	Based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Secondary Outcome Measures

Name	Time	Method
Incidence of late GU and GI toxicities (≥6 months)	Through accrual completion, up to 3 years	Using CTCAE v5.0
Biochemical disease-free survival (bDFS)	Through study completion, up to 3 years	Biochemical disease-free survival (bDFS)

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada