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

Radical Prostatectomy Clinical Trial

— PLUTO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04067570
• Other study ID #: PLUTO
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 7, 2019
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Radical Prostatectomy
• SBRT

Intervention

Radiation:
• 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

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of late GU and GI toxicities (=6 months)	Using CTCAE v5.0	Through accrual completion, up to 3 years
Secondary	Biochemical disease-free survival (bDFS)	Biochemical disease-free survival (bDFS)	Through study completion, up to 3 years