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Study Summary
No. RTOG 0232:.......Prostate......Deborah A. Kuban......Radiation Oncology
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Study Summary Title
Study Summary
Number:
RTOG 0232
Study Title:A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy with Brachytherapy Alone for Selected Patients with Intermediate Risk Prostatic Carcinoma
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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:713-792-5862
Contact us about clinical trials
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General Information
Disease Group:ProstateSupported By:RTOG
Phase of Study:3Return
Visit:
Initial f/up vst w/in 3-5 wks of implant to coincide w/post-implant CT. After initial f/up vst, f/up will be done at 4,6,9 & 12 mths post trtmt start. Then evry 6 mths until 5 yrs post-implant. Then annually thereafter.
Treatment
Agents:
Collection
Imaging
Home Care:None
Treatment Loc:outpatient
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
Unavailable
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Study Objectives / Outcomes
Unavailable
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Study Status Information
Study Activation / Registration Date:11/18/2003
IRB Review and Approval Date:10/15/2003
Study Type:Therapeutic
Recruitment Status:Open
Projected Accrual:75
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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:Histologically confirmed, locally confined adenocarcinoma of the prostate.

Clinical stages T1c-T2b (AJCC 6th Edition, see Appendix III).

Zubrod Performance Scale 0-1.

Patients must be equal to or older than 18 years of age.

Combined Gleason score 7 if PSA less than 10, combined Gleason score less than 7 if PSA is 10-20.

PSA must be equal to or less than 20 ng/mL, before hormone therapy, if given (if Gleason score is 2-6, then PSA must be equal to or greater than 10 ng/mL).

Prostate volume by TRUS equal to or less than 60 cc.

No prior chemotherapy or pelvic radiation- no prior TURP, cryosurgery, TUNA, TUMT or radical surgery for carcinoma of the prostate.

No distant metastases, no clinically or pathologically involved lymph nodes.

No significant obstructive symptoms- AUA score must be equal to or less than 15 (alpha blockers allowed).

No hip prosthesis.

No major medical or psychiatric illness.

Signed study-specific informed consent form prior to study entry.

Neoadjuvant hormonal therapy beginning 2-6 months prior to registration is acceptable. The use of 5-alpha reductase inhibitors (for example, finasteride) is allowed prior to registration but should be discontinued before registration.

No previous or concurrent cancer other than basal cell or squamous cell skin cancer or in situ at another site, unless disease free for at least 5 ye

If has used a 5-alpha reductase inhibitor, it has been discontinued.


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