Intensity Modulated Radiation Therapy - Prostate Cancer

Phase 1

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Procedure: conformal intensity modulated radiotherapy (IMRT)

• Registration Number: NCT00188513
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2006-04
• Study Completion: 2017-04-04
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-08
• Last Update Posted: 2018-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 267

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Conformal intensity modulated radiotherapy (IMRT)	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.

Primary Outcome Measures

Name	Time	Method
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	at each post treatment follow-up for up to 3 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada