High-risk Prostate Cancer
Conditions
Keywords
high risk prostate cancer, hypofractionated radiation treatment, higher biological doses, acceptable rectal toxicity, Radiation Treatment
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.
Interventions
39 radiation treatments
25 radiation treatments
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| The biochemical control (freedom from PSA failure) rate | 10 years |
| Disease free survival | 10 years |
Countries
Canada