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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000626194 | Registry Identifier | PDQ (Physician Data Query) | |
| EUDRACT 2004-003495-11 | |||
| EU-20892 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Active Comparator | Patients continue to receive LHRH-A 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug | Given IV |
| |
| releasing hormone agonist therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year progression-free survival rate |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | ||
| Time to treatment failure | ||
| Toxicity as assessed by NCI CTCAE criteria |
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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:
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rete Oncologica Piemontese - Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino | Recruiting | Turin | 10126 | Italy |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005834 | Genital Neoplasms, Male |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Drug |
Patients receive luteinizing hormone-releasing hormone analogue therapy until disease progression. |
|
| 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) |
| Quality of life |
| Efficacy of treatment in controlling bone pain |
| Changes in chromogranin A levels |
| Cost analysis |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |