Adult Clinical Trials:HEAD AND NECK

RTOG 0232: PROSTATE

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

• Histologically confirmed, locally confined adenocarcinoma of the prostate.
• Clinical stages T1c-T2b.
• Zubrod 0-1.
• Combined Gleason 7 if PSA < 10, combined Gleason < 7 if PSA 10-20; PSA must be < 20ng/mL, before hormone therapy, if given (if Gleason 2-6, then PSA must be > 10 ng/mL; Prostate volume by TRUS < 60 cc.
• No prior chemotherapy, pelvic radiation, no prior TURP, cryosurgery, TUNA, TUMT or radical surgery for carcinoma of the prostate.
• No previous hormonal therapy beginning < 2 months or > 6 months prior to registration
• No distant metastases, no clinically or pathologically involved lymph nodes.
• No significant obstructive symptoms.
• AUA must be < 15 (alpha blockers allowed).
• No major medical or psychiatric illness.

Treatment

Arm 1: 45 Gy EBRT, partial pelvis (1.8 Gy/fraction M-F for 5 weeks) followed 2-4 weeks later by Pd-103 (100 Gy) or I-125 (110 Gy)*
Arm 2: Pd-103 (125 Gy) or I-125 (145 Gy)*
*Protocol treatment must begin within 4 weeks after study entry.

RTOG 0521:  PROSTATE

A Phase III Protocol of Androgen Suppression (AS) And 3DCRT/IMRT Vs AS and 3DCRT/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer
Histologically confirmed (within 180 days prior to registration) prostate cancer at high-risk for recurrence as determined by one of the following combinations:

• Clinically negative lymph nodes as established by imaging (pelvic CT or pelvic MR), nodal sampling, or dissection within 90 days prior to registration

Treatment

Arm 1
AS (LHRH agonist and oral antiandrogen) x 8 weeks followed by RT to 72.0-75.6 Gy with concurrent AS (LHRH agonist and oral antiandrogen). LHRH will continue for a total of 24 months from initiation of any treatment. Oral antiandrogen will be discontinued at the end of radiotherapy.

Arm 2
AS (LHRH agonist and oral antiandrogen) x 8 weeks followed by RT to 72.0-75.6 Gy with concurrent AS (LHRH agonist and oral antiandrogen). LHRH will continue for a total of 24 months from initiation of any treatment. Oral antiandrogen will be discontinued at the end of RT.
PLUS
Six cycles of docetaxel and prednisone delivered concurrently with androgen suppression beginning 28 days after completion of RT:
Docetaxel i.v. over 1 hour (on day 1 of each cycle) q 21 days
(Premedication for docetaxel with dexamethasone is required)
AND
Prednisone p.o. daily until day 21 of the last cycle of chemotherapy.

RTOG 0612: PROSTATE

Investigating Markers of Radiation Outcome in Patients With Intermediate-Risk Prostate Cancer Using DNA Microarray Analysis: An RTOG Pilot Study

• Patient must be eligible for RTOG 0232.
• Patient must be enrolled on RTOG 0232.
• Submission of the paraffin tissue block from initial diagnosis.
•  Submission of the biopsy specimen that contains frozen tissue.
•  Patient must sign a study-specific informed consent for RTOG 0612 prior to study entry.