Status:
TERMINATED
External Beam Radiation Therapy (EBRT) With or Without Hormonal Therapy in Prostate Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE3
Brief Summary
Primary Objective: * To assess the possible improvement in prostate specific antigen (PSA) outcome of short course androgen suppression therapy in conjunction with dose-escalation intensity modulated...
Detailed Description
Prior patient studies have shown that short-term hormone therapy (about 4 months) before and during radiation therapy can benefit patients with bulky tumors or locally-advanced prostate tumors. These ...
Eligibility Criteria
Inclusion
- Biopsy proven prostate cancer within last 12 months. Pathology must be reviewed at M.D. Anderson Cancer Center (MDACC).
- 1992 American Joint Committee on Cancer (AJCC) clinical stage T1c-2b on digital rectal exam with biopsy Gleason sum of 7 and Prostate-Specific Antigen (PSA) \< 20 ng/mL (i.e. PSA 19.99 ng/mL or less)
- 1992 AJCC clinical stage T2b on physical exam with biopsy Gleason sum of 7 or less and/or PSA \< 20 ng/ml
- 1992 AJCC clinical stage T1c-2b on digital rectal exam with biopsy Gleason sum of 7 or less and PSA \> 10 but less than 20 ng/ml (i.e. 10.01-19.99 ng/mL). PSA used for protocol eligibility should be obtained within 30 days of protocol enrollment.
- No evidence of metastatic disease on bone scan within 3 months of study enrollment.
- No evidence of metastatic disease on pelvic computed tomography (CT) or magnetic resonance imaging (MRI) within 3 months of study enrollment.
- Zubrod performance status \< 2.
- Must be able to understand protocol and adhere to follow-up initially at 3 months post-radiation and then at 6 month intervals for first two years and annually thereafter.
- Patient must be able to undergo adequate daily trans-abdominal ultrasound localization (B.A.T.) or other image-guided localization of the prostate during radiation course.
- Patients will be allowed to participate in other protocols if they are eligible and the other protocols do not interfere with participation in this protocol.
Exclusion
- Patients who do not meet the inclusion criteria. Specifically, patients with all the following features: clinical T1c-2a and Gleason sum of 6 and PSA \</= 10 ng/ml. Patients with one or more of the following features: clinical T2c, or Gleason 8-10, or PSA \> 20 ng/ml are not eligible.
- Prior androgen suppression therapy. (Prior finasteride and saw palmetto allowed but must be discontinued prior to enrollment. Biopsy and PSA must be documented prior to finasteride use.)
- Previous or concurrent malignancies other than basal or squamous cell skin cancers unless disease-free for 5 years or more.
- Prior pelvic radiation or chemotherapy. Patients who received chemotherapy for non-prostate cancer malignancies over 5 years prior will be eligible.
- Prior or planned radical prostate surgery.
- Patients with clinical evidence or biopsy-proven extracapsular extension, seminal vesicle involvement, or lymph node involvement will be excluded. Patients with radiographic evidence of nodal or bone metastasis will be excluded.
- Other histologies such as small cell carcinoma, sarcomatoid or ductal variants are not eligible.
- Patients with any Gleason grade 5 disease on biopsy will not be eligible.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00388804
Start Date
February 1 2005
End Date
April 1 2011
Last Update
August 8 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030