Status:
TERMINATED
Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients
Lead Sponsor:
AHS Cancer Control Alberta
Conditions:
High-risk Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2018
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT01488968
Start Date
March 1 2012
End Date
October 15 2018
Last Update
June 29 2025
Active Locations (1)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2