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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00796458
• Other study ID #: GOUP-01/04
• Secondary ID: CDR0000626194EUD
• Status: Recruiting
• Phase: Phase 3
• First received: November 21, 2008
• Last updated: August 9, 2013
• Start date: April 2005

Study information

• Verified date: November 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• docetaxel
Given IV
• releasing hormone agonist therapy
Patients receive luteinizing hormone-releasing hormone analogue therapy until disease progression.

Locations

Country	Name	City	State
Italy	Rete Oncologica Piemontese - Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino	Turin

Sponsors (1)

Lead Sponsor	Collaborator
A.O.U. San Giovanni Battista di Torino, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year progression-free survival rate			No
Secondary	Overall survival			No
Secondary	Time to treatment failure			No
Secondary	Toxicity as assessed by NCI CTCAE criteria			Yes
Secondary	PSA response rate (> 50% reduction from baseline)			No
Secondary	Disease response rate as assessed by RECIST criteria (in patients with measurable disease)			No
Secondary	PSA normalization (normal range 0-4 ng/mL)			No
Secondary	Quality of life			No
Secondary	Efficacy of treatment in controlling bone pain			No
Secondary	Changes in chromogranin A levels			No
Secondary	Cost analysis			No