Stereotactic Body Radiotherapy (SBRT) Post Prostatectomy (PLUTO-MPC)

Sunnybrook Health Sciences Centre

Status

Active, not recruiting

Conditions

Prostate Cancer

Treatments

Radiation: stereotactic body radiotherapy (SBRT)

Study type

Interventional

Funder types

Other

Identifiers

NCT04848909

3596

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)