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Intensity Modulated Radiation Therapy - Prostate Cancer

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
conformal intensity modulated radiotherapy (IMRT)
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Conformal intensity modulated radiotherapy (IMRT)

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To evaluate acute toxicity of therapy
To evaluate local control as assessed by prostate biopsy at 2.5 years
To evaluate time to disease progression

Full Information

First Posted
September 12, 2005
Last Updated
June 8, 2018
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00188513
Brief Title
Intensity Modulated Radiation Therapy - Prostate Cancer
Official Title
A Phase I-II Prospective Trial of Conformal Hypofractionated Intensity Modulated Radiotherapy (IMRT) for Localized Adenocarcinoma of the Prostate
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
267 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conformal intensity modulated radiotherapy (IMRT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
conformal intensity modulated radiotherapy (IMRT)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To evaluate acute toxicity of therapy
Time Frame
weekly during RT
Title
To evaluate local control as assessed by prostate biopsy at 2.5 years
Time Frame
2.5 years
Title
To evaluate time to disease progression
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Catton, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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Intensity Modulated Radiation Therapy - Prostate Cancer

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