PLUTO: Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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) |
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
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Outcome Measures
Primary Outcome Measures
- 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
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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• Histologically confirmed diagnosis of adenocarcinoma of the prostate
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Completed written informed consent
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Able and willing to complete self report questionnaires
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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:
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• Gross residual disease
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Histological or radiological node +ve (N1) or distant metastases (M1)
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Prior pelvic radiotherapy
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Contraindications to radical pelvic radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)
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Hip prosthesis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N3M5 |
Sponsors and Collaborators
- Sunnybrook Health Sciences Centre
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PLUTO