Status:
TERMINATED
Leuprolide Acetate or Goserelin Acetate Compared With Observation in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Adenocarcinoma
Stage IIA Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 wh...
Detailed Description
PRIMARY OBJECTIVES: I. To compare the difference in the biochemical progression-free survival rate (bPFS) at 2-years between immediate androgen deprivation therapy (ADT) for nine months in high risk ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00937768
Start Date
July 1 2009
End Date
July 1 2012
Last Update
December 27 2019
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905