Intensity Modulated Radiation Therapy - Prostate Cancer

A Phase I-II Prospective Trial of Conformal Hypofractionated Intensity Modulated Radiotherapy (IMRT) for Localized Adenocarcinoma of the Prostate

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Procedure: conformal intensity modulated radiotherapy (IMRT)

• Study Type: Interventional
• Enrollment (Anticipated): 267
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: conformal intensity modulated radiotherapy (IMRT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Princess Margaret Hospital, Canada
• Investigators: Principal Investigator: Charles Catton, MD, Princess Margaret Hospital, Canada

Study record dates

Study Major Dates

• Study Start: May 1, 2001
• Primary Completion (Actual): April 1, 2006
• Study Completion (Actual): April 4, 2017

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Actual): June 12, 2018
• Last Update Submitted That Met QC Criteria: June 8, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: UHN REB 01-0181-C