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

NCT04067570 | Active Not Recruiting

• 1 other identifier: PLUTO
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

SBRT; Radical Prostatectomy

Keywords

Prostate cancer; Radiation; Ultrahypofractionated Radiotherapy; PSA Rise; SBRT

Outcome Measures

Primary Outcomes (1)

• Acute genitourinary (GU) and gastrointestinal (GI) toxicities

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

  Through accrual completion, up to 3 years

Secondary Outcomes (2)

• 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 Arms (1)

SBRT post operative

EXPERIMENTAL

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)

Radiation: SBRT

Interventions

SBRT RADIATION

Stereotactic body radiation therapy, or SBRT, is a cancer treatment that delivers extremely precise, very intense doses of radiation to cancer cells while minimizing damage to healthy tissue

SBRT post operative

Eligibility Criteria

• Gender Eligibility Details: Prostate Cancer- male patients only
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 26, 2019
• Study Start: November 7, 2019
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

CA (1)