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

NCT00937768 | Terminated Phase 2 Results

• 4 other identifiers: MC0852NCI-2009-0114708-001519P30CA015083
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Prostate Adenocarcinoma; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Biochemical Progression-free Survival Rate

  Biochemical progression-free survival (BPFS) was defined as the time from randomization to the time of biochemical progression. If a patient dies without a documentation of biochemical progression, the patient will be considered to have had progressed at the time of death.

  2 years

Secondary Outcomes (4)

• Number of Deaths

  2 years

• Percentage of Participants With Grade 3 or Higher Adverse Events Regardless of Attribution

  2 years

• Average Overall FACT-P Total Score at Baseline, Months 3 and 6

  Baseline and months 3 and 6

• Average LASA Overall Quality of Life at Baseline, Months 3 and 6

  Baseline to Months 3 and 6

Other Outcomes (3)

• Correlation of Circulating Tumor Cells or Circulating Endothelial Cells Following Study Treatments With Biochemical Progression-free Survival Rate

  2 years

• Evaluation of Prognostic and Predictive Tissue Based Biomarkers (CTCs, CECs)

  2 years

• Measurements of Serum and Urine Biomarkers, and Comparison Between the Two Arms

  2 years

Study Arms (2)

Arm A (antihormone therapy)

EXPERIMENTAL

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; Other: Laboratory Biomarker Analysis; Drug: Leuprolide Acetate; Other: Quality-of-Life Assessment

Arm B (no antihormone therapy)

NO INTERVENTION

Patients undergo observation every 3 months for 9 months.

Interventions

Goserelin Acetate DRUG

Given SC

Also known as: ZDX, Zoladex

Arm A (antihormone therapy)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm A (antihormone therapy)

Leuprolide Acetate DRUG

Given IM

Also known as: 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

Arm A (antihormone therapy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (antihormone therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Goserelin; Leuprolide; luprolide acetate gel depot

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Dr. R. Jeffrey Karnes
• Organization: Mayo Clinic

Karnes.R@mayo.edu

507 284-4430

Study Officials

• Robert Karnes

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 13, 2009
• Study Start: July 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 27, 2019
• Results First Posted: December 6, 2013

Record last verified: 2018-12

Locations

US (1)