Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients

NCT ID: NCT01488968

Last Updated: 2025-06-29

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2018-10-15

Brief Summary

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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.

Detailed Description

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Conditions

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High-risk Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard

Standard Radiation Treatment

Group Type ACTIVE_COMPARATOR

Standard Radiation Treatment

Intervention Type RADIATION

39 radiation treatments

Hypofractionated

Hypofractionated

Group Type EXPERIMENTAL

Hypofractionated radiation treatment

Intervention Type RADIATION

25 radiation treatments

Interventions

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Standard Radiation Treatment

39 radiation treatments

Intervention Type RADIATION

Hypofractionated radiation treatment

25 radiation treatments

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AHS Cancer Control Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Canada

Other Identifiers

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25859

Identifier Type: -

Identifier Source: org_study_id

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