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Study Summary
No. ID00-381:.......Genitourinary......Deborah A. Kuban......Radiation Oncology
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Study Summary Title
Study Summary
Number:		ID00-381
Study Title:A Phase III Intensity Radiotherapy Dose Escalation for Prostate Cancer Using Hypofractionation
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Physician New Patient Referral
Name:Deborah A. KubanPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Radiation OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-2300
Contact us about clinical trials
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General Information
Disease Group:GenitourinarySupported By:N/A
Phase of Study:Phase IIIReturn
Visit:		Q 6 months x 2 years and then annually
Treatment
Agents:		RadiationHome Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		Unavailable
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Study Objectives / Outcomes
1. This study will assess the efficacy of 72 Gy in 30 fractions HIMRT (85 Gy BED assuming an a¤b of 1.5) relative to 75.6 Gy in 42 fractions CIMRT. The main end point will be the incidence of a rising PSA. Information on local control, freedom from distant metastasis and overall survival will also be acquired.

2. To establish local failure by biopsy of the prostate when objective tests (PSA, ultrasound, DRE) suggest relapse.

3. To determine the rates of late side effects at 2, 3, 4 and 5 years post-treatment using questionnaires to assess bladder, rectal, and sexual function.

4. To obtain the pretreatment prostate biopsy material to assess prospectively the predictive value of various potential prognostic factors, such as, p53, bcl-2, bax and Ki-67.

5. To assess the prognostic value of pretreatment serum testosterone, sex hormone binding globulin, and estradiol.
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Study Status Information
Study Activation / Registration Date:01/23/2001
IRB Review and Approval Date:01/03/2001
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Biopsy proof of adenocarcinoma of the prostate.

2) 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.

3) CT-scan of pelvis (If Stage T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation.

4) Suitable medical condition; Zubrod <2.

5) 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.

6) Clinical (palpable) Stage T1b - T3b disease (1992 AJCC staging system).

7) 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

8) Gleason score <10.

9) If Gleason score 8 or 9, then must have stage T1/T2 disease and pretreatment PSA less than or equal to 10 ng/ml.

10) 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.

11) Informed consent must be given.

12) Patients randomized to Arm 1 may also participate in protocol 2004-0428.
Exclusion Criteria:1) Prior pelvic radiotherapy.

2) Greater than 4 months of prior hormone ablation therapy.

3) Prior or planned radical prostate surgery.

4) Clinical, radiographic or pathologic evidence of nodal or distant metastatic disease.

5) 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.

6) Zubrod status greater than or equal to 2.

7) Pretreatment PSA >20 ng/ml.

8) Gleason score of 10.

9) Palpable stage T3c (seminal vesicle involvement) or T4 disease.
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Links
Registration Number: NCT00667888
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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