Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients (CHIRP)

AHS Cancer Control Alberta

Status: Terminated

Conditions: High-risk Prostate Cancer

Treatments: Radiation: Standard Radiation Treatment; Radiation: Hypofractionated radiation treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01488968

25859

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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111 participants in 2 patient groups

Standard

Active Comparator group

Description:

Standard Radiation Treatment

Treatment:

Radiation: Standard Radiation Treatment

Hypofractionated

Experimental group

Description:

Hypofractionated

Treatment:

Radiation: Hypofractionated radiation treatment