Androgen Ablation With or Without Docetaxel in Treating Patients With Advanced Prostate Cancer - Full Text View

Sponsor:	Rete Oncologica Piemontese - Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00796458

Purpose

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.

Condition	Intervention	Phase
Pain Prostate Cancer	Drug: docetaxel Drug: releasing hormone agonist therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label
Official Title:	Phase III Study of Chemo-Hormonal Therapy Versus Hormonal Therapy Alone in Advanced Hormone-Naives Prostate Cancer Patients.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

2-year progression-free survival rate [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Time to treatment failure [ Designated as safety issue: No ]
Toxicity as assessed by NCI CTCAE criteria [ Designated as safety issue: Yes ]
PSA response rate (> 50% reduction from baseline) [ Designated as safety issue: No ]
Disease response rate as assessed by RECIST criteria (in patients with measurable disease) [ Designated as safety issue: No ]
PSA normalization (normal range 0-4 ng/mL) [ Designated as safety issue: No ]
Quality of life [ Designated as safety issue: No ]
Efficacy of treatment in controlling bone pain [ Designated as safety issue: No ]
Changes in chromogranin A levels [ Designated as safety issue: No ]
Cost analysis [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	April 2005
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Active Comparator 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.
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 Given IV Drug: releasing hormone agonist therapy Patients receive luteinizing hormone-releasing hormone analogue therapy until disease progression.

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.

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796458

Locations

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

Sponsors and Collaborators

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

Investigators

Principal Investigator:	Oscar Bertetto, MD	Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
Investigator:	Isabella Chiappino, MD	Rete Oncologica Piemontese - Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000626194, GOUP-01/04, EUDRACT 2004-003495-11, EU-20892
Study First Received:	November 21, 2008
Last Updated:	February 13, 2009
ClinicalTrials.gov Identifier:	NCT00796458 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male

Hormones
Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009