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

NCT ID: NCT04067570

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-07
• Study Completion Date: 2030-10-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SBRT post operative

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)

Group Type: EXPERIMENTAL

SBRT

Intervention Type: 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

Interventions

SBRT

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

Intervention Type: RADIATION

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Chia-Lin (Eric) Tseng

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

PLUTO

Identifier Type: -

Identifier Source: org_study_id