This trial is active, not recruiting.

Condition prostatic neoplasms
Treatment conformal intensity modulated radiotherapy (imrt)
Phase phase 1/phase 2
Sponsor University Health Network, Toronto
Collaborator Princess Margaret Hospital, Canada
Start date May 2001
End date April 2006
Trial size 267 participants
Trial identifier NCT00188513, UHN REB 01-0181-C


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
conformal intensity modulated radiotherapy (imrt)

Primary Outcomes

To determine feasibility and late toxicity of administering 66 Gy in 22 fractions over 4.5 weeks (using conformal IMRT treatment techniques) to the prostate and adjacent tissues in patients with localized prostate ca
time frame: at each post treatment follow-up for up to 3 years

Secondary Outcomes

To evaluate acute toxicity of therapy
time frame: weekly during RT
To evaluate local control as assessed by prostate biopsy at 2.5 years
time frame: 2.5 years
To evaluate time to disease progression
time frame: 5 years

Eligibility Criteria

Male participants from 18 years up to 80 years old.

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

Additional Information

Official title A Phase I-II Prospective Trial of Conformal Hypofractionated Intensity Modulated Radiotherapy (IMRT) for Localized Adenocarcinoma of the Prostate
Principal investigator Charles Catton, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.