Stereotactic Body Radiotherapy (SBRT) Post Prostatectomy

Study Overview
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Brief Summary
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This phase I study will assess the toxicity profile and efficacy of SBRT (Stereotactic body radiotherapy) in patients with localized prostate cancer who are considered candidates for post-prostatectomy radiation.

Detailed Description
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Radical prostatectomy is a common treatment for localized prostate cancer, patients with a detectable and/or rising PSA after radical prostatectomy may be offered radiation. An increasing number of patients are being referred post-operatively for radiotherapy, which creates an added burden on radiotherapy departments. Therefore, a strategy that could potentially decrease the number of radiotherapy fractions, yet maintain its efficacy, would be highly desirable for patient convenience, cost saving, and resource utilization as long as the toxicity profile is acceptable. This study will be conducted to asses the toxicity and efficacy of Stereotactic body radiotherapy (SBRT) in post-prostatectomy patients.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: stereotactic body radiotherapy (SBRT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed diagnosis of adenocarcinoma of the prostate status post radical prostatectomy Completed written informed consent Able and willing to complete EPIC, PORPUS, and EQ-5D questionnaires A detectable PSA ≤ 2.0 ng/ml Two consecutive rises in PSA and final PSA > 0.1 ng/ml OR three or more consecutive rises in PSA Exclusion Criteria: Gross residual disease (per conventional imaging, i.e. CT and/or MRI) 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: men diagnosed with prostate cancer post-prostatectomy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Men with prostate cancer post-prostatectomy<br>Men with localized prostate cancer who are considered candidates for post-prostatectomy radiation. | Radiation: stereotactic body radiotherapy (SBRT)<br>* Stereotactic body or external-beam radiation therapy (SBRT) is a method of delivery of radiation in precision manner to the prostate bed in this study. The SBRT dose prescription will be 3000 cGy in 5 fractions to the prostate bed and 2500 cGy in 5 fractions to the pelvic nodes if elective nodal irradiation (ENI) is used, delivered every other business day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Adverse Events/toxicities experience by Participants | Incidence of acute GU and GI toxicities, based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | 6.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Adverse Events/toxicities experienced by Participants | Incidence of late GU and GI toxicities (≥6 months) using CTCAE v5.0 | 6.5 years | 
| Quality of Life of participants using the Expanded Prostate Cancer Index Composite questionnaire | Acute and late GU and GI quality of life (QoL) using the Expanded Prostate Cancer Index Composite questionnaire which evaluates participant's function and bother after prostate cancer treatment. Each question is scored from 1-5, 1 being the better outcome and 5 being the worst outcome. | 6.5 years | 
| Biochemical disease-free survival | Biochemical disease-free survival (bDFS), defined as survival until first evidence of either biochemical progression (PSA of 0.4 ng/mL or greater) following postoperative radiotherapy, PSA of more than 2.0 ng/mL at any time after postoperative radiotherapy, clinical or radiological progression, initiation of non-protocol hormone therapy, or death from prostate cancer | 6.5 years | 
| Health Utilities using The Patient-Oriented Prostate Utility Scale | Health utilities using The Patient-Oriented Prostate Utility Scale to measure health-related quality of life, whether it improves, deteriorates or stay the same. There are 10 questions, each questions has 5 possible answers, with 1 being the better outcome and 5 being the worst outcome. | 6.5years | 
| Health Utilities using EuroQol- 5 Dimension Questionnaire | Health utilities using the EuroQol- 5 Dimension Questionnaire determines 5 variables, each with 5 possible options, with the first being the best outcome and the last being the worst outcome. The 5 variables include: Mobility Self-care Usual Activities Pain/discomfort Anxiety/depression | 6.5years |