Leuprolide Acetate or Goserelin Acetate Compared With Observation in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy
Condition: Prostate Adenocarcinoma; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Goserelin Acetate; Laboratory Biomarker Analysis; Leuprolide Acetate; Quality-of-Life Assessment
Intervention description: Given SC; Correlative studies; Given IM; Ancillary studies
Intervention MeSH terms: Leuprolide; Goserelin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies the side effects and how well giving leuprolide
      acetate or goserelin acetate works compared to observation in treating patients with
      high-risk prostate cancer who have undergone radical prostatectomy. Androgens can cause the
      growth of prostate cancer cells. Antihormone therapy, such as goserelin acetate and
      leuprolide acetate, may lessen the amount of androgens made by the body and thus control
      prostate cancer growth. Many times, after surgery, the tumor may not need more treatment
      until it progresses. In this case, observation may be sufficient. However, in some prostate
      cancers there is a chance that tumors can re-grow despite surgery based on certain high risk
      features.
    

Eligibility criteria:

        Inclusion Criteria:

          -  PRE-REGISTRATION:

          -  Informed consent explained and signed prior to any study related procedures

          -  Patients with any one of the following "high risk" criteria:

               -  Clinical or pathological Gleason score 8-10

               -  Prostate-specific antigen (PSA) > 20 ng/ml at initial presentation prior to
                  radical prostatectomy

          -  Willingness to provide mandatory tissue for research purposes

          -  Willingness to provide mandatory blood for research purposes

          -  Has no history of androgen deprivation therapy within the past 6 months or has been
             treated neoadjuvantly up to 6 months prior to radical prostatectomy with the following
             agents; luteinizing hormone-releasing hormone (LHRH) agonists, anti-androgens, 5
             alpha-reductase inhibitors, and peripheral anti-androgens

          -  REGISTRATION:

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2; or
             Karnofsky performance of > 60%

          -  Patients with any one of the following "high risk" criteria:

               -  Gleason, prostate specific antigen, seminal vesicle and margin status (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)

               -  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

          -  Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =< 2 x
             institutional upper limit of normal (ULN)

          -  Total bilirubin =< 2 x institutional ULN

          -  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

          -  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 reconfirmed post radical prostatectomy; these patient groups
             may choose to register prior to or after prostatectomy

          -  Study randomization must occur =< 28 days of radical prostatectomy; all patients
             consented on the trial, whether consented in the pre-prostatectomy or
             post-prostatectomy period, will be randomized to study treatments =< 28 days of
             prostatectomy

          -  Ability to complete questionnaire(s) by themselves or with assistance

        Exclusion Criteria:

          -  PRE-REGISTRATION

          -  Transitional cell, small cell, or squamous cell carcinoma of the prostate; NOTE:
             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

          -  History of primary prostate cancer treatment

          -  Evidence of clinical nodal disease (N1) or grossly evident metastasis at the time of
             enrollment

          -  History of bilateral orchiectomy; unilateral orchiectomy with normal range serum
             testosterone levels will be allowed for enrollment

          -  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,
             computed tomography (CT) and/or magnetic resonance (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; 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

          -  Receiving other experimental drugs =< 4 weeks prior to consenting

          -  Uncontrolled infection

          -  History of other cancer, excluding squamous cell and basal cell skin cancers, within
             the preceding 2 years

          -  Documented history of human immunodeficiency virus (HIV) positivity or other acquired
             immunodeficiency disorder, congenital immunodeficiency disorder, or history of organ
             transplantation

          -  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

          -  Unable to follow up every three months for the first year to Mayo Clinic, Rochester
             for receiving LHRH analogues or study monitoring