Upstate Active Clinical Trials Seeking Participants
Study title
A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT vs. AS and 3DCRT/IMRT Followed by Chemotherapy with Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer
IRB number
59
What is the purpose of the study?
The standard treatment for this stage of prostate cancer is a combination of radiation therapy and hormones. The main purpose of this study is to try to find out if adding chemotherapy to this standard treatment is more effective than the standard treatment by itself. It is hoped that chemotherapy will be found to provide additional benefits, but chemotherapy has significant side effects. The use of chemotherapy is experimental in prostate cancer; it needs to be tested to determine more about its benefits and side effects.
Who is eligible?
1) histologically confirmed prostate cancer within 180 days prior to registration, at high risk for recurrence as determined by one of the following combinations: Gleason Score PSA T-Stage > 9 and < 150 and Any 8 and < 20 and > T2 8 and > 20-150 and Any 7 and > 20-150 and Any
2) clinically negative lymph nodes as established by imaging (pelvic CT or MRI), nodal sampling, or dissection within 90 days prior to registration
3) bone scan within 90 days prior to registration
4) no distant metastases
5) performance status 0-1; no severe, active co-morbidities
6) acceptable laboratory values (ANC, platelets, hemoglobin, PSA, ALT/AST, alkaline phosphatase, total bilirubin)
7) no prior treatment for prostate cancer other than pharmacological androgen ablation started no more than 50 days prior to registration; no bilateral orchiectomy or pelvic radiation for any reason
What is involved if I participate?
- How long is the study?
Treatment will take place over a period of 24 months. For 8-9 weeks of this time period, all subjects will receive radiation therapy five days each week. After radiation therapy is completed, subjects assigned to chemotherapy will receive an intravenous (IV) infusion every three weeks and take another drug orally (by mouth) for about 18 weeks. All subjects will see their study doctor for follow-up exams every 3 months for the first 2 years, then every 6 months for 3 years, then once a year thereafter. - Is transportation provided or reimbursed?
No - Is parking provided or reimbursed?
No - What tests and procedures are involved?
Before Entering the Study - Bone scan, CT or MRI of the pelvis, Blood tests (PSA, testosterone, liver tests, blood counts). During the Study Blood tests (PSA, testosterone, liver tests, blood counts) Treatment Groups All study subjects will be randomly assigned to one of the following groups: Group 1 - Subjects will begin treatment with androgen suppression (AS) which will continue for 24 months. - Radiation therapy (RT) will begin 8 weeks after the start of AS and will continue for 8-9 weeks. Group 2 - Subjects will begin treatment with androgen suppression (AS) which will continue for 24 months. - Radiation therapy (RT) will begin 8 weeks after the start of AS and will continue for 8-9 weeks. - Beginning 28 days after RT ends, subjects will receive two chemotherapy drugs: docetaxel and prednisone. Docetaxel is given through a needle in a vein in the arm for one hour. This will be repeated every 3 weeks (21 days) for a total of six times. In addition, subjects will take prednisone from the day they first receive docetaxel until 21 days after the last dose of docetaxel.
Who is the doctor administering the study?
Jeffrey A. Bogart, M.D.
Where will the study take place?
Radiation Therapy: University Hospital, Hill Radiation Oncology, Oswego County Radiation Oncology
Chemotherapy: University Hospital, Regional Oncology Center, 550 Harrison Center, Oneida Clinic, Oswego Clinic
Over what time period is the study scheduled to run?
Available June 2007 locally; closure estimated December 2010, depending on rate of required subject enrollment.
Who can I contact for more information?
- Name: Dena Martin
- Phone: 315-464-5262
- Email: martind@upstate.edu
- Fax: 315-464-5943
If you are interested in this trial, please contact the study coordinator or investigator noted above.
