Intensity Modulated Radiation Therapy - Prostate Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Health Network, Toronto.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Health Network, Toronto
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188513
First received: September 12, 2005
Last updated: December 28, 2005
Last verified: September 2005
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostatic Neoplasms |
Procedure: conformal intensity modulated radiotherapy (IMRT) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I-II Prospective Trial of Conformal Hypofractionated Intensity Modulated Radiotherapy (IMRT) for Localized Adenocarcinoma of the Prostate |
Resource links provided by NLM:
Further study details as provided by University Health Network, Toronto:
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
| Estimated Enrollment: | 267 |
| Study Start Date: | May 2001 |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00188513
Contacts
| Contact: Charles Catton, MD | 416-946-2121 | charles.catton@rmp.uhn.on.ca |
Locations
| Canada, Ontario | |
| Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Charles Catton, MD 416-946-2121 charles.catton@rmp.uhn.on.ca | |
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
| Principal Investigator: | Charles Catton, MD | Princess Margaret Hospital, Canada |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00188513 History of Changes |
| Other Study ID Numbers: | UHN REB 01-0181-C |
| Study First Received: | September 12, 2005 |
| Last Updated: | December 28, 2005 |
| Health Authority: | Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
Neoplasms Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013