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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

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

NCTNCT00937768 (opens ClinicalTrials.gov in a new tab)Other idMC0852Other idNCI-2009-01147Other id08-001519Other idMC0852

Overview

Status
Terminated
Phase
Phase 2
Enrollment
16 participants (actual)
Sponsor
Mayo Clinic · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jul 2009
Primary completion
Jun 2012
Completion
Jul 2012
First posted
13 Jul 2009 (estimated)
Last update posted
27 Dec 2019
Conditions
Prostate Adenocarcinoma · Stage IIA Prostate Cancer · Stage IIB Prostate Cancer · Stage III Prostate Cancer · Stage IV Prostate Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20092010201120122013
  1. Ph 2

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

    NCT00937768

    Jul 2009 to Jul 2012

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Goserelin AcetateDrug
  • Laboratory Biomarker AnalysisOther
  • Leuprolide AcetateDrug
  • Quality-of-Life AssessmentOther

Arms2

  • 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.

  • No intervention

    Arm B (no antihormone therapy)

    Patients undergo observation every 3 months for 9 months.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Biochemical Progression-free Survival Rate

    Time frame · 2 years

    Registry description

    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.

Secondary outcomes(4)
  1. Number of Deaths

    Time frame · 2 years

    Registry description

    The number of deaths due to any cause are reported below.

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

    Time frame · 2 years

    Registry description

    Percentage of Participants with Grade 3 or Higher Adverse Events regardless of attribution per NCI CTCAE Version 3

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

    Time frame · Baseline and months 3 and 6

    Registry description

    The overall FACT-P Total Score at Baseline and months 3 and 6 mean and standard deviations are reported below. The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 where higher scores represent better quality of life.

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

    Time frame · Baseline to Months 3 and 6

    Registry description

    LASA Overall Quality of Life at Baseline, Months 3 and 6. Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The average and standard deviation of the LASA overall quality of life score are reported below at baseline, months 3 and 6.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· 2 years

Biochemical Progression-free Survival Rate

GroupValue
Androgen Deprivation Therapynot posted
No Androgen Deprivation Therapynot posted
Secondary and other outcome results(7)
Secondary outcomeCount of participants· 2 years

Number of Deaths

GroupValue (Participants)
Androgen Deprivation Therapy0
No Androgen Deprivation Therapy0
Secondary outcomeNumber· 2 years

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

GroupValue (percentage of patients)
Androgen Deprivation Therapy100
No Androgen Deprivation Therapy37.5
Secondary outcomeMean· Baseline and months 3 and 6

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

GroupValue (score on a scale)Spread
Androgen Deprivation Therapy122.75.9
No Androgen Deprivation Therapy114.816.92
Secondary outcomeMean· Baseline to Months 3 and 6

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

GroupValue (score on a scale)Spread
Androgen Deprivation Therapy8.80.75
No Androgen Deprivation Therapy6.91.77
Other pre specified outcome· 2 years

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

GroupValue
Androgen Deprivation Therapynot posted
No Androgen Deprivation Therapynot posted
Other pre specified outcome· 2 years

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

GroupValue
Androgen Deprivation Therapynot posted
No Androgen Deprivation Therapynot posted
Other pre specified outcome· 2 years

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

GroupValue
Androgen Deprivation Therapynot posted
No Androgen Deprivation Therapynot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Androgen Deprivation TherapyPatients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.0 / 80 / 88 / 8
No Androgen Deprivation TherapyPatients undergo observation every 3 months for 9 months.0 / 81 / 86 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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