Changes in DNA After Radiation Therapy in Patients With Prostate Cancer

OBJECTIVES:

Primary

- Demonstrate the feasibility of acquiring specimens, both frozen and paraffin-embedded,
to yield RNA of adequate quality to perform DNA microarray studies on markers of
radiotherapy outcome in patients with intermediate-risk prostate cancer.

Secondary

- Compare the gene expression results from frozen tissue and paraffin-embedded tissue to
see the correlation between the 2 methods in patients treated on the brachytherapy
alone arm of protocol RTOG-0232.

- Find genes that are expressed differentially before and after radiation therapy in
patients treated on the brachytherapy plus external-beam radiation therapy arm of
protocol RTOG-0232.

- Find gene expression patterns in patients treated on either arm of protocol RTOG-0232
who have significant associations with biochemically as well as clinically apparent
local and distant failure.

OUTLINE: This is a multicenter, pilot study.

Frozen and paraffin-embedded tissue samples are studied for biomarker/laboratory analysis.
DNA microarray analysis is performed on the samples to assess markers of radiotherapy
outcome.

PROJECTED ACCRUAL: A total of 156 patients will be accrued for this study.

Inclusion Criteria:

- Histologically confirmed, locally confined adenocarcinoma of the prostate

- Zubrod performance 0-1

- Clinical stages T1c - T2b, N0, M0

- Combined Gleason score 7 if prostate specific antigen (PSA) < 10, combined Gleason
score < 7 if PSA 10 - 20; PSA must be ≤ 20 ng/mL, before hormone therapy, if given,
and a prostate volume by transrectal ultrasound (TRUS) ≤ 60 cc.

- American Urological Association (AUA) score ≤ 15 (alpha blockers are allowed).

- Age ≥ 18 years old and must sign a study-specific informed consent form

Exclusion Criteria:

- No clinically or pathologically involved lymph nodes

- No distant metastases or significant obstructive symptoms

- No prior chemotherapy, pelvic radiation, transurethral prostatectomy (TURP),
cryosurgery, TUNA, transurethral microwave thermotherapy (TUMT) or radical surgery
for carcinoma of the prostate is allowed.

- No previous hormonal therapy beginning < 2 months or > 6 months prior to registration
is allowed.

- No previous or concurrent cancers other than basal, in situ, or squamous cell skin
cancers unless the patient is disease free for ≥ 5 years.

- No hip prosthesis or major medical or psychiatric illnesses are allowed. prior to
study entry.