MDACC Study Summary RTOG 0232

Study Summary
No. RTOG 0232:.......Prostate......Steven J. Frank......Radiation Oncology

Study Summary Title



Study Summary Number:	RTOG 0232

Study Title:	A Phase III Study Comparing Combined External Beam Radiation Transperineal Interstitial Permanent Brachytherapy with Brachytherapy Alone for Selected Patients with Intermediate Risk Prostatic Carcinoma

Physician

New Patient Referral



Name:	Steven J. Frank	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-5905 Contact us about clinical trials

General Information



Disease Group:	Prostate	Supported By:	Radiation Therapy Oncology Group (RTOG) RTOG

Phase of Study:	Phase III	Return Visit:	Initial follow-up visit within 3-5 wks of implant to coincide with post-implant CT.

Treatment Agents:	Radiation	Home Care:	None

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	N/A

Description/
Intervention:

The goal of this clinical research study is to compare the effects of external
radiation treatments given before an internal radiation treatment, compared to
an internal radiation treatment alone. The internal radiation treatment is
brachytherapy (also known as implant therapy). The external radiation
treatment is external beam radiation. This will be tested in patients with
prostate cancer.

The safety and level of effectiveness of these treatments will be compared, as
well as participants' quality of life after treatment.

Study Objectives / Outcomes

The primary goal of this study is to determine whether combined external beam radiation (EBRT) and transperineal interstitial permanent brachytherapy will result in better freedom from progression (FFP) for 5 years compared to brachytherapy alone among selected patients with intermediate risk prostatic carcinoma.

The secondary endpoints are to compare EBRT in addition to transperineal interstitial brachytherapy versus interstitial brachytherapy alone as related to: (a) biochemical failure, (b) biochemical failure by the Phoenix definition, (c) disease-specific survival, (d) local progression, (e) distant metastases and (f) overall survival.

To evaluate differences in toxicity and quality of life between EBRT and transperineal interstitial brachytherapy arm and interstitial brachytherapy alone arm.

Feasibility of collecting Medicare data in large RTOG prostate trial for cost effectiveness and cost utility analysis of combined radiation therapy.

Prospectively collect diagnostic biopsy samples for future biomarker analyses.

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:	586

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) Histologically confirmed adenocarcinoma of the prostate, clinical stage T1c - T2b (AJCC 6th Edition, see Appendix III), N0, M0.

2) Zubrod performance status 0-1.

3) Patient must be greater than or equal to 18 years of age.

4) Patients with intermediate risk prostate cancer as determined by one of the following combinations: Gleason < 7, PSA must be 10-20; Gleason 7, PSA must be < 10.

5) Prostate specific antigen (PSA) prior to study entry (and prior to any hormone treatment if given) must be less than or equal to 20 ng/ml.

6) 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.

7) Prostate volumes by TRUS less than or equal to 60 cc.

8) AUA voiding symptom scores less than or equal to 15 (alpha blockers allowed); this is completed by the patient.

9) Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:

1) Stage < T1c, T2c, T3 or T4 disease (AJCC 6th Edition, see Appendix III).

2) Lymph node involvement (N1).

3) Evidence of distant metastases (M1).

4) Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior TURP, prior cryosurgery, TUNA, TUMT of the prostate.

5) Previous hormonal therapy beginning < 2 months or > 6 months prior to registration. The use of hormones should not be a planned component of therapy.

6) Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for greater than or equal to 5 years.

7) Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.

8) Hip prosthesis.

Links

Registration Number: NCT00063882
Study Information on Clinical Trials Registry (clinicaltrials.gov)