Phase II Trial of Temporary Androgen Deprivation Therapy in High Risk Prostate Cancer Following Radical Prostatectomy

Inclusion Criteria

Inclusion:

Prostate cancer patients with high-risk features may be screened for participation either
prior to (pre-registration) or after (registration) radical prostatectomy

Pre-registration: Informed consent explained and signed prior to any study related
procedures

Pre-registration: Patients with any one of the following "high risk" criteria: clinical or
pathological Gleason score 8-10; PSA > 20 ng/mL at initial presentation prior to radical
prostatectomy

Pre-registration: Willingness to provide mandatory tissue for research purposes

Pre-registration: Willingness to provide mandatory blood for research purposes

Registration: ECOG performance status of 0, 1, or 2; or Karnofsky performance of > 60%

Registration: Patients with any one of the following "high risk" criteria: GPSM score >=
10 [GS + 1*(PSA 4-10)+2*(PSA 10.1-20)+3*(PSA>20)+2*(Seminal Vesicular or nodal
involvement) +2*(margin)] (determined post radical prostatectomy)

Registration: Patients with any one of the following "high risk" criteria (continued from
previous criterion): post prostatectomy seminal vesicle invasion (pT3b) or pT4; two or
less microscopic lymph nodal metastasis determined at the time of prostatectomy; or
Gleason 4+3 at the time of prostatectomy with margin positivity

Registration: Please contact study investigator and/or consult protocol document for
specific details on laboratory criteria

Registration:

High risk patients will do one of the following:

1. for patients identified as high-risk on the basis of pathological criteria after
undergoing radical prostatectomy: interval time for study enrollment after radical
prostatectomy will be <= 28 days of the prostatectomy;

2. for patients identified as high-risk prior to undergoing radical prostatectomy:
patients presenting with a high Gleason score (8-10) and/or a PSA >20 ng/ml are
deemed eligible for study participation and study registration as long as the
eligibility criteria is re-confirmed post radical prostatectomy

Registration: These patient groups may choose to register prior to or after prostatectomy

Registration: Study randomization must occur =< 28 days of radical prostatectomy

Registration: All patients consented on the trial, whether consented in the
pre-prostatectomy or postprostatectomy period, will be randomized to study treatments =<
28 days of prostatectomy

Registration: Ability to complete questionnaire(s) by themselves or with assistance

Exclusion

Pre-registration: Transitional cell, small cell, or squamous cell carcinoma of the
prostate

Pre-registration: Patients consented for participation prior to prostatectomy, if detected
to have above listed histo-pathologies after prostatectomy will be deemed ineligible and
not proceed to study randomization

Pre-registration: History of primary prostate cancer treatment

Pre-registration: Evidence of clinical nodal disease (N1) or grossly evident metastasis at
the time of enrollment

Pre-registration: Androgen deprivation therapy within the past 6 months (these agents
include LHRH agonists, anti-androgens, 5 alpha-reductase inhibitors, estrogens,
ketoconazole, or corticosteroids or peripheral anti-androgens)

Pre-registration: History of bilateral orchiectomy

Pre-registration: Unilateral orchiectomy with normal range serum testosterone levels will
be allowed for enrollment

Pre-registration: Evidence of metastasis on radiographic metastatic workup within a
preceding period of 4 months from the time of study entry, including whole body
radionuclide bone scan, CT and/or MR scan of the pelvis and abdomen; otherwise will
perform at the time of the baseline tests and result must be normal to continue on study

Pre-registration: Results of ProstaScint or other radionuclide scans, excluding
radionuclide bone scans, will NOT be used to establish metastatic disease if all other
studies are negative

Pre-registration: Receiving other experimental drugs =< 4 weeks prior to consenting
Pre-registration: Uncontrolled infection

Pre-registration: History of other cancer, excluding squamous cell and basal cell skin
cancers, within the preceding 2 years

Pre-registration: Documented history of HIV positivity or other acquired immunodeficiency
disorder, congenital immunodeficiency disorder, or history of organ transplantation

Pre-registration: Unable to follow up every three months for the first year to Mayo
Clinic, Rochester for receiving LHRH analogues or study monitoring

Registration: Uncontrolled infection Registration: Unable to follow up every three months
for the first year to Mayo Clinic, Rochester for receiving LHRH analogues or study
monitoring