Status:
COMPLETED
Intensity Modulated Radiation Therapy - Prostate Cancer
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Princess Margaret Hospital, Canada
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18-80 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 4 2017
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT00188513
Start Date
May 1 2001
End Date
April 4 2017
Last Update
June 12 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9