Clinical trial NCT04848909: Stereotactic Body Radiotherapy (SBRT) Post Prostatectomy
Official title: Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer: A Treatment Feasibility and Outcomes Multicenter Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: SBRT
Ultrahypofractionated Radiotherapy
Localized Prostate Cancer
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Royal Victoria Regional Health Centre
name: Princess Margaret Hospital, Canada
name: Credit Valley Hospital
First posted: 2021-04-19
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: men diagnosed with prostate cancer post-prostatectomy
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Early Adverse Events/toxicities experience by Participants
timeFrame: 6.5 years
Secondary outcomes:
measure: Late Adverse Events/toxicities experienced by Participants
timeFrame: 6.5 years
measure: Quality of Life of participants using the Expanded Prostate Cancer Index Composite questionnaire
timeFrame: 6.5 years
measure: Biochemical disease-free survival
timeFrame: 6.5 years
measure: Health Utilities using The Patient-Oriented Prostate Utility Scale
timeFrame: 6.5years
measure: Health Utilities using EuroQol- 5 Dimension Questionnaire
timeFrame: 6.5years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Odette Cancer Centre
state: Onatrio
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Dr. Chia-Lin Tseng, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: