Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients
NCT ID: NCT01488968
Last Updated: 2025-06-29
Study Results
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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TERMINATED
NA
111 participants
INTERVENTIONAL
2012-03-31
2018-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Standard
Standard Radiation Treatment
Standard Radiation Treatment
39 radiation treatments
Hypofractionated
Hypofractionated
Hypofractionated radiation treatment
25 radiation treatments
Interventions
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Standard Radiation Treatment
39 radiation treatments
Hypofractionated radiation treatment
25 radiation treatments
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
MALE
No
Sponsors
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AHS Cancer Control Alberta
OTHER
Responsible Party
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Principal Investigators
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Albert Murtha
Role: PRINCIPAL_INVESTIGATOR
Cross Cancer Institute
Locations
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Cross Cancer Institute
Edmonton, Alberta, Canada
Countries
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Other Identifiers
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25859
Identifier Type: -
Identifier Source: org_study_id
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