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Clinical Trials/NCT04067570
NCT04067570
Active, not recruiting
Not Applicable

Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer: A Treatment Feasibility and Outcomes Study

Sunnybrook Health Sciences Centre1 site in 1 country30 target enrollmentNovember 7, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
SBRT
Sponsor
Sunnybrook Health Sciences Centre
Enrollment
30
Locations
1
Primary Endpoint
Acute genitourinary (GU) and gastrointestinal (GI) toxicities
Status
Active, not recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 7, 2019
End Date
October 2030
Last Updated
11 months ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chia-Lin (Eric) Tseng

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

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

Outcomes

Primary Outcomes

Acute genitourinary (GU) and gastrointestinal (GI) toxicities

Time Frame: Through accrual completion, up to 3 years

Based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Secondary Outcomes

  • Incidence of late GU and GI toxicities (≥6 months)(Through accrual completion, up to 3 years)
  • Biochemical disease-free survival (bDFS)(Through study completion, up to 3 years)

Study Sites (1)

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