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.
Condition: High-risk Prostate Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT01488968
Sponsor: AHS Cancer Control Alberta
- Age: minimum 18 Years maximum N/A
- Gender: Male
- 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.
View trial on ClinicalTrials.gov