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

NCT00796458 | Unknown Phase 3

• 4 other identifiers: GOUP-01/04CDR0000626194EUDRACT 2004-003495-11EU-20892
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Prostate Cancer

Keywords

pain; adenocarcinoma of the prostate; recurrent prostate cancer; stage IV prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (1)

• 2-year progression-free survival rate

Secondary Outcomes (10)

• Overall survival

• Time to treatment failure

• 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)

Study Arms (2)

Arm I

ACTIVE COMPARATOR

Patients continue to receive LHRH-A therapy until disease progression.

Drug: releasing hormone agonist therapy

Arm II

EXPERIMENTAL

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; Drug: releasing hormone agonist therapy

Interventions

docetaxel DRUG

Given IV

Arm II

releasing hormone agonist therapy DRUG

Patients receive luteinizing hormone-releasing hormone analogue therapy until disease progression.

Arm I; Arm II

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• A.O.U. San Giovanni Battista di Torino, Italy: lead

Study Sites (1)

Rete Oncologica Piemontese - Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

Turin, 10126, Italy

RECRUITING

MeSH Terms

Conditions

Pain; Prostatic Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Oscar Bertetto, MD

  Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

  PRINCIPAL INVESTIGATOR

• Isabella Chiappino, MD

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 21, 2008
• First Posted: November 24, 2008
• Study Start: April 1, 2005
• Primary Completion: October 1, 2013
• Last Updated: August 12, 2013

Record last verified: 2008-11

Locations

IT (1)