Radiation Therapy for Rising Prostate Specific Antigen (PSA) Post-prostatectomy

Standard Treatment:

If you are found to be eligible and you choose to take part, you will be enrolled in this
study. Study participants will be those who are receiving the standard radiation treatment
for prostate cancer, which has come back after surgical removal of the prostate. If your PSA
level is lower, you will receive radiation alone. If your PSA level is higher, you will
receive hormone therapy in addition to radiation. You will sign a separate consent form that
will describe these treatments and their risks in more detail. This study requires no other
treatment. The main purpose of this study is data gathering through the use of questionnaires
and tissue banking.

Follow-Up Tests

After your treatment (radiation with or without hormone therapy), you will receive routine
follow-up care. The results of the following routine tests will be entered into the registry:

- After completing radiation, blood (about 1 tablespoon) will be drawn to check your PSA
levels every 3 months for the first 2 years, every 6 months for the next 3 years, and
every year from then on.

- If you receive hormone therapy, additional blood (about 1 tablespoon) will be drawn to
check the levels of testosterone hormone. These blood tests to check your testosterone
levels will be drawn at the same time as your PSA blood tests, until your testosterone
levels are in the normal range.

- Every 6 months for the first 2 years after completing radiation, you will have a
physical exam and a digital rectal exam. After that, the physical exam and digital
rectal exam will be repeated every year from then on.

Information Collection:

While you are on study, on a long-term basis, researchers will collect information from your
medical records about the status of the disease. This information will be entered into the
registry. To identify you, the registry uses your medical record number instead of your name
or other identifying information. The registry is password-protected to keep the data secure.

Length of Study Participation:

You will be on study for as long as you agree to keep taking part. If you go off study, your
data will no longer be entered into the registry.

Inclusion Criteria:

1. Adenocarcinoma of the prostate definitively treated by radical prostatectomy.

2. Patients must have no evidence of nodal or distant metastasis by clinical and
radiologic staging to include bone scan and CT scan or MRI of the abdomen and pelvis.
Patients with clinical or radiographic local recurrence are eligible. In patients with
Gleason score less than or equal to 7 and PSA less than or equal to 1, CT or MRI of
the abdomen is recommended but not required.

3. Rising PSA after prostatectomy defined as at least 2 consecutive rises. If total PSA <
0.2 ng/ml, surgical pathology must also show extracapsular extension, positive
margins, or seminal vesicle involvement.

4. Total PSA < 5 ng/ml within 12 weeks prior to starting radiation or hormone therapy.

5. Patients with PSA greater than or equal to 0.5 ng/ml may have up to 3 months of an
LHRH agonist and an anti-androgen immediately prior to enrollment.

6. All patient must have a serum testosterone of 150 ng/dl or greater documented prior to
initiation of hormone therapy. Alternatively, patients without documentation of serum
testosterone prior to initiation of hormone therapy should not have had any other
prior hormone therapy within the 24 months preceding initiation of hormone therapy.

Exclusion Criteria:

1. Patients with pathologically positive pelvic lymph nodes at prostatectomy.

2. Patients with positive prostascint scans outside prostatic fossa.

3. Any chemotherapy, immunotherapy, biological therapy for cancer within 90 days of
enrollment.

4. Hormone therapy (specifically LHRH agonist or antagonist, non-steroidal or steroidal
antiandrogens) of more than 6 months duration at any time in the past for prostate
cancer.

5. Contraindications to external beam radiation therapy to include previous pelvic
radiation, inflammatory bowel disease or history of collagen vascular disease.