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.
(Study was terminated due to funding issues.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00937768
First received: July 9, 2009
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

RATIONALE: 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.

PURPOSE: This phase II trial is studying the side effects and how well leuprolide acetate or goserelin acetate work compared to observation) in treating patients with high-risk prostate cancer who have undergone radical prostatectomy.


Condition Intervention Phase
Prostate Cancer
Drug: leuprolide acetate
Drug: goserelin
Other: laboratory biomarker analysis
Other: quality-of-life assessment
Other: pharmacological study
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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: October 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
Drug: leuprolide acetate
Given IM
Other Names:
  • LEUP
  • Lupron
  • Lupron Depot
  • Enantone
  • 6-D-leucine-9-(N-ethyl-L-prolinamide)-1-9-luteinizing hormone-releasing factor (pig) monoacetate
  • 6-D-leucine-9-(N-ethyl-L-prolinamide)-10-deglycinamide luteinizing hormone-releasing factor (pig) monoacetate
Drug: goserelin
Given SC
Other Names:
  • ZDX
  • Zoladex
  • 6-[O-(1,1-dimethylethyl)-D-serine]-10-deglycinamide luteinizing hormone-releasing factor (pig) 2-(aminocarbonyl)hydrazide
  • ICI-118630
  • 65807-02-5
Other: laboratory biomarker analysis
Correlative study
Other: quality-of-life assessment
Correlative study
Other Name: quality of life assessment
Other: pharmacological study
Correlative study
Other Name: pharmacological studies
No Intervention: Arm B
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 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 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:

This is a randomized phase II study.

Patients are stratified according to pathological Gleason score (6-7 vs >=8) and baseline PSA at diagnosis (<10 ng/mL vs >=10 ng/mL). Patients are randomized to 1 of 2 arms.

Arm A: Patients receive leuprolide acetate intramuscularly on day 1 OR goserelin acetate subcutaneously on day 1. Treatment repeats every 3 months for a up to 3 courses 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 every three months for 2 years. PROJECTED ACCRUAL: A total of 128 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

  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
Investigators
Study Chair: Robert Karnes, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00937768     History of Changes
Other Study ID Numbers: MC0852, MC0852, NCI-2009-01147, 08-001519
Study First Received: July 9, 2009
Results First Received: October 8, 2013
Last Updated: December 5, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Leuprolide
Goserelin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 20, 2014