Stereotactic Body Radiotherapy (SBRT) Post Prostatectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-03

Study Completion Date

2034-12-31

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.

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

men diagnosed with prostate cancer post-prostatectomy

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Men with prostate cancer post-prostatectomy

Men with localized prostate cancer who are considered candidates for post-prostatectomy radiation.

Group Type EXPERIMENTAL

stereotactic body radiotherapy (SBRT)

Intervention Type RADIATION

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.

Interventions

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stereotactic body radiotherapy (SBRT)

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.

Intervention Type RADIATION

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)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No