Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients

Study Overview
=================
Brief Summary
-----------------
Hypofractionated regimen in high-risk prostate cancer will allow the investigators to deliver higher biological doses to targets in order to improve tumor control and with acceptable rectal toxicity compared to conventional fractionation.

Official Title
-----------------
A Phase II Randomized Control Trial of Conventional Versus Hypofractionated Radiation Regimen in Single Phase Using IMRT Technique and Long Term Androgen Suppression Therapy in High-risk Prostate Cancer Patients.

Conditions
-----------------
High-risk Prostate Cancer

Intervention / Treatment
-----------------
* Radiation: Standard Radiation Treatment
* Radiation: Hypofractionated radiation treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is 18 years of age or older Patient has histologically proven adenocarcinoma of prostate gland by needle core samples or TURP with assigned Gleason score. Prostate biopsy performed within 180 days of enrollment (date of consent). Patient has high-risk prostate cancer (stage T3 or T4) and/or PSA greater than or equal to 20 ng/ml and/or Gleason score 8 to 10 No clinical or radiological evidence of nodal or distant metastasis(es). In the opinion of the treating oncologist, patient is fit to undergo radical external beam radiotherapy to the prostate. Patients are accessible for treatment and follow up. Patient does not have history of inflammatory bowel disease, anal stenosis, colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases. No history of prostatectomy, transurethral resection of prostate on more than one occasion or previous pelvic radiotherapy. No history of androgen suppression for greater than or equal to 6 months and patient is willing for androgen suppression treatment as per standard or at physician's discretion. No previous malignancy within last five years except BCC or SCC skin or highly curable malignancy where a prognosis for cure is > 80%. Patient signed informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard<br>Standard Radiation Treatment | Radiation: Standard Radiation Treatment<br>* 39 radiation treatments<br>|
| Experimental: Hypofractionated<br>Hypofractionated | Radiation: Hypofractionated radiation treatment<br>* 25 radiation treatments<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The biochemical control (freedom from PSA failure) rate |  | 10 years | 
| Disease free survival |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high risk prostate cancer, hypofractionated radiation treatment, higher biological doses, acceptable rectal toxicity, Radiation Treatment