Intensity Modulated Radiation Therapy - Prostate Cancer

NCT ID: NCT00188513

Last Updated: 2018-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 267 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2017-04-04

Brief Summary

There are several different treatment schedules being used across the world for treatment of prostate cancer with radiation therapy. In order to determine the best radiation treatment for this disease, a study is being performed by the doctors at the Princess Margaret Hospital. This study will try to measure the effectiveness and side effects of an increased dose of radiation to the prostate that is also given over a shorter number of weeks than is usually done. In order to try to reduce the possible side effects of the radiation therapy the treatment will be given using special techniques to shield as much of your normal body tissues as possible. This method of treatment is called conformal intensity modulated radiation therapy, or IMRT.

Conditions

Prostatic Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conformal intensity modulated radiotherapy (IMRT)

All patients shall receive a continuous course of intensity modulated conformal radiotherapy consisting of 66 Gy in 22 (3 Gy) fractions over 4.5 weeks.

Group Type: EXPERIMENTAL

conformal intensity modulated radiotherapy (IMRT)

Intervention Type: PROCEDURE

Interventions

conformal intensity modulated radiotherapy (IMRT)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Histologic diagnosis of adenocarcinoma of the prostate within six months of entry
• Clinical stage T1B, T1C, T2A-C NX MO (see Appendix 1 for staging). Any Gleason score is eligible for entry, but Gleason score must be determined.
• Patients with a PSA >10.0 and Gleason score of 7; or patients with any PSA value and Gleason score of >8 must have clinically negative lymph nodes as determined by a pelvic CT scan done within 12 weeks of entry. A negative bone scan is required before entry for all patients with Gleason score >8, or any patient with a Gleason score of 7, and a PSA >10.
• The patient must not have received any cytotoxic anticancer therapy. Previous or concurrent hormonal therapy for local disease is acceptable.
• ECOG performance status of 1 or less
• Age 80 years old or less
• Serum PSA <25 ng/ml within 4 weeks of study entry
• Informed consent

Exclusion Criteria

• Patients with history of inflammatory bowel disease or other contraindication to radical radiation therapy
• Patients with prior colorectal surgery
• Any prior pelvic radiotherapy. Any prior TURP done <12 weeks from study entry.
• Any previous cytotoxic chemotherapy
• Patients with prior malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of prostate cancer

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Catton, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN REB 01-0181-C

Identifier Type: -

Identifier Source: org_study_id