Leuprolide Acetate or Goserelin Acetate Compared With Observation in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy

This study has been terminated.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00937768
First received: July 9, 2009
Last updated: December 11, 2015
Last verified: October 2015
  Purpose
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.

Condition Intervention Phase
Prostate Adenocarcinoma
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
Drug: Goserelin Acetate
Other: Laboratory Biomarker Analysis
Drug: Leuprolide Acetate
Other: Quality-of-Life Assessment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Temporary Androgen Deprivation Therapy in High Risk Prostate Cancer Following Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Biochemical Progression-free Survival Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical Progression-free Survival (BPFS), Overall Survival (OS), and Prostate Cancer Specific Survival (PCS) [ Designated as safety issue: No ]
  • Toxicity as Per NCI CTCAE Version 3 [ Designated as safety issue: Yes ]
  • Quality of Life as Assessed by the FACT-P and LASA Tool Within and Between the Two Treatment Arms [ Time Frame: Baseline and months 3, 6, 9, 12, 15, 18, 21, and 24 ] [ Designated as safety issue: No ]
  • Measurements of Serum and Urine Biomarkers, and Comparison Between the Two Arms [ Designated as safety issue: No ]
  • Correlation of Circulating Tumor Cells or Circulating Endothelial Cells Following Study Treatments With Biochemical Progression-free Survival Rate [ Designated as safety issue: No ]
  • Evaluation of Prognostic and Predictive Tissue Based Biomarkers (CTCs, CECs) [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: July 2009
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A (antihormone therapy)
Patients receive leuprolide acetate IM on day 1 OR goserelin acetate SC on day 1. Courses repeat every 3 months for 9 months in the absence of disease progression or unacceptable toxicity.
Drug: Goserelin Acetate
Given SC
Other Names:
  • ZDX
  • Zoladex
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Leuprolide Acetate
Given IM
Other Names:
  • A-43818
  • Abbott 43818
  • Abbott-43818
  • Carcinil
  • Depo-Eligard
  • Eligard
  • Enanton
  • Enantone
  • Enantone-Gyn
  • Ginecrin
  • LEUP
  • Leuplin
  • Leuprorelin Acetate
  • Lucrin
  • Lucrin Depot
  • Lupron
  • Lupron Depot
  • Lupron Depot-3 Month
  • Lupron Depot-4 Month
  • Lupron Depot-Ped
  • Procren
  • Procrin
  • Prostap
  • TAP-144
  • Trenantone
  • Uno-Enantone
  • Viadur
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
No Intervention: Arm B (no antihormone therapy)
Patients undergo observation every 3 months for 9 months.

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 prostate cancer patients following radical prostatectomy and a similar high risk patient population followed without initiation of immediate ADT treatment.

SECONDARY OBJECTIVES:

I. To determine the difference in bPFS, prostate cancer specific survival, and overall survival between immediate ADT for nine months and observation for high risk prostate cancer patients following radical prostatectomy.

II. To evaluate the toxicity profile and quality of life (QOL) measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) and linear analogue self assessment (LASA) between two treatment arms.

TERTIARY OBJECTIVES:

I. To explore if serum and urine biomarker(s) levels at study entry, 9 months, or 24 months in the two treatment arms are correlated with biochemical progression-free survival rate.

II. To explore if > 5 circulating tumor cells (CTCs) or circulating endothelial cells (CECs) following study treatments are associated with biochemical progression-free survival rate.

III. To explore the prognostic and predictive value of tissue based biomarkers in high risk prostate cancer patients.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1. Courses repeat every 3 months for 9 months in the absence of disease progression or unacceptable toxicity.

ARM B: Patients undergo observation every 3 months for 9 months.

After completion of study treatment, patients are followed up every three months for 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937768

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Robert Karnes Mayo Clinic
  More Information

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00937768     History of Changes
Other Study ID Numbers: MC0852  NCI-2009-01147  08-001519  MC0852  P30CA015083 
Study First Received: July 9, 2009
Results First Received: October 8, 2013
Last Updated: December 11, 2015
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Leuprolide
Goserelin
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 28, 2016