Status:
UNKNOWN
A Phase III Intensity Radiotherapy Dose Escalation for Prostate Cancer Using Hypofractionation
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE3
Brief Summary
The goal of this clinical research study is to compare using external beam radiotherapy with intensity modulated beams for fewer days at a higher dose per day to the same type of therapy for more days...
Detailed Description
Patients in this study will be randomly picked (as in the toss of a coin) to be in one of two treatment groups. There is an equal chance of being in either group. Patients in Group 1 will be treated ...
Eligibility Criteria
Inclusion
- Biopsy proof of adenocarcinoma of the prostate.
- Bone scan (If PSA \>10 ng/ml or T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation.
- CT-scan of pelvis (If Stage T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation.
- Suitable medical condition; Zubrod \<2.
- Pretreatment PSA \</=20 ng/ml. If PSA \<4, must have Gleason greater than or equal to 7 and/or Stage T2b-T2c. PSA within 30 days of signing protocol consent. If neoadjuvant androgen ablation has been given, then the preandrogen ablation PSA should be used for stratification.
- Clinical (palpable) Stage T1b - T3b disease (1992 AJCC staging system).
- While a transrectal ultrasound will be obtained before treatment, the staging will not be based on these findings. If palpable T3 disease is present, then must have Gleason score \<8 and pretreatment PSA less than or equal to 10 ng/ml
- Gleason score \<10.
- If Gleason score 8 or 9, then must have stage T1/T2 disease and pretreatment PSA less than or equal to 10 ng/ml.
- The patient must be able to understand the protocol and adhere to follow-up at 6-month intervals for the first 2 years and at yearly intervals thereafter.
- Informed consent must be given.
- Patients randomized to Arm 1 may also participate in protocol 2004-0428.
Exclusion
- Prior pelvic radiotherapy.
- Greater than 4 months of prior hormone ablation therapy.
- Prior or planned radical prostate surgery.
- Clinical, radiographic or pathologic evidence of nodal or distant metastatic disease.
- Concurrent, active malignancy, other than nonmetastatic skin cancer or early stage -chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for greater than or equal to 5 yr then the patient is eligible.
- Zubrod status greater than or equal to 2.
- Pretreatment PSA \>20 ng/ml.
- Gleason score of 10.
- Palpable stage T3c (seminal vesicle involvement) or T4 disease.
Key Trial Info
Start Date :
January 3 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT00667888
Start Date
January 3 2001
End Date
October 1 2021
Last Update
January 25 2021
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030