Androgen Ablation With or Without Docetaxel in Treating Patients With Advanced Prostate Cancer

August 9, 2013 updated by: A.O.U. San Giovanni Battista di Torino, Italy

Phase III Study of Chemo-hormonal Therapy Versus Hormonal Therapy Alone in Advanced Hormone-naives Prostate Cancer Patients.

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving androgen ablation therapy together with docetaxel is more effective than giving androgen ablation therapy alone in treating patients with advanced prostate cancer.

PURPOSE: This randomized phase III trial is studying androgen ablation and docetaxel to see how well they work compared with androgen ablation alone in treating patients with advanced prostate cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Compare the 2-year progression-free survival rate (biological progression and/or clinical progression) in patients with advanced prostate cancer treated with androgen ablation with vs without docetaxel.

Secondary

  • Compare the overall survival of patients treated with these regimens.
  • Compare the time to treatment failure in patients treated with these regimens.
  • Compare the toxicity profiles of these regimens in these patients.
  • Compare the PSA response rate in patients treated with these regimens.
  • Compare the response rate in patients with measurable disease treated with these regimens.
  • Compare the percentage of patients who undergo PSA normalization.
  • Compare the quality of life of patients treated with these regimens.
  • Compare the efficacy of these regimens in controlling bone pain in these patients.
  • Compare the changes in chromogranin A levels in patients treated with these regimens.
  • Compare the total cost of care of patients treated with these regimens.

OUTLINE: This is a multicenter study.

Patients receive luteinizing hormone-releasing hormone analogue (LHRH-A) therapy for 6 months. Patients also receive antiandrogen therapy during the first 5 weeks of LHRH-A therapy. After 6 months of LHRH-A therapy, patients with PSA response are randomized to 1 of 2 treatment arms.

  • Arm I: Patients continue to receive LHRH-A therapy until disease progression.
  • Arm II:Patients receive LHRH-A therapy as in arm I. Patients also receive docetaxel IV on day 1. Treatment with docetaxel repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients complete questionnaires during treatment to assess bone pain. Quality of life is also assessed.

After completion to study therapy, patients are followed for ≥ 2 years.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Turin, Italy, 10126
        • Recruiting
        • Rete Oncologica Piemontese - Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
        • Contact:
          • Isabella Chiappino, MD
          • Phone Number: 39-011-633-4250

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

  • Meets one of the following criteria

    • Metastatic disease
    • Systemic progressive disease after locoregional therapy (surgery or radiotherapy)

    • No metastatic disease AND meets one of the following criteria:

      • Circulating PSA levels ≥ 50 ng/mL (confirmed by ≥ 2 subsequent evaluations)
      • Biochemical progression with a PSA doubling time < 6 months (with ≥ 3 measurements taken 1 month apart) after primary locoregional treatment (radical prostatectomy or radiotherapy) with curative intent
      • Prostate-confined tumor with high-risk features whose therapy of choice is androgen deprivation
  • No symptomatic brain metastases or leptomeningeal disease

PATIENT CHARACTERISTICS:

  • ECOG or Zubrod performance status 0-2
  • Life expectancy ≥ 6 months
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Bilirubin ≤ 2.0 mg/dL
  • AST/ALT ≤ 1.5 times upper limit of normal
  • Creatinine ≤ 1.5 mg/dL
  • No active infection requiring IV antibiotics
  • No active ulcer, unstable diabetes mellitus, or other contraindication to corticotherapy

  • None of the following cardiovascular conditions:

    • Uncompensated heart failure (ejection fraction < 40%)
    • Myocardial infarction or revascularization procedure within the past 6 months
    • Unstable angina pectoris
    • Uncontrolled cardiac arrhythmia
  • No other severe clinical condition that, in the judgment of the local investigator, would place the patient at undue risk or interfere with the study
  • Not a prisoner
  • No prior malignancy, except for non-melanoma skin cancer, in situ cervical carcinoma, or other cancer that was curatively treated with no evidence of disease for ≥ 5 years
  • No familial, social, or geographical condition or significant neurologic or psychiatric disorder that would preclude understanding or rendering informed consent or fully complying with study treatment and follow-up

PRIOR CONCURRENT THERAPY:

  • At least 5 years since prior radiotherapy outside the prostate
  • Prior hormonal therapy allowed provided it was administered for ≤ 6 months
  • At least 12 months since prior hormonal therapy
  • More than 30 days since prior participation in another clinical trial involving investigational agents
  • No prior surgical castration
  • Concurrent androgen deprivation for prostate cancer allowed provided it was started ≤ 3 months prior to initiation of study treatment
  • Concurrent anticoagulant treatment allowed
  • No other concurrent investigational drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I
Patients continue to receive LHRH-A therapy until disease progression.
Drug: releasing hormone agonist therapy
Patients receive luteinizing hormone-releasing hormone analogue therapy until disease progression.
Experimental: Arm II
Patients receive LHRH-A therapy as in arm I. Patients also receive docetaxel IV on day 1. Treatment with docetaxel repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Drug: docetaxel
Given IV
Drug: releasing hormone agonist therapy
Patients receive luteinizing hormone-releasing hormone analogue therapy until disease progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
2-year progression-free survival rate

Secondary Outcome Measures

Outcome Measure
Time to treatment failure
Overall survival
Quality of life
Cost analysis
Toxicity as assessed by NCI CTCAE criteria
PSA response rate (> 50% reduction from baseline)
Disease response rate as assessed by RECIST criteria (in patients with measurable disease)
PSA normalization (normal range 0-4 ng/mL)
Efficacy of treatment in controlling bone pain
Changes in chromogranin A levels

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A.O.U. San Giovanni Battista di Torino, Italy

Investigators

  • Principal Investigator: Oscar Bertetto, MD, Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
  • Isabella Chiappino, MD, A.O.U. San Giovanni Battista di Torino, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

November 21, 2008

First Submitted That Met QC Criteria

November 21, 2008

First Posted (Estimate)

November 24, 2008

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOUP-01/04
  • CDR0000626194 (Registry Identifier: PDQ (Physician Data Query))
  • EUDRACT 2004-003495-11
  • EU-20892

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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