Docetaxel and Prednisone in Treating Patients With Hormone-Refractory Metastatic Prostate Cancer
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| ClinicalTrials.gov Identifier: NCT00255606 |
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Recruitment Status :
Completed
First Posted : November 21, 2005
Last Update Posted : June 26, 2013
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RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which schedule of docetaxel and prednisone is more effective in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying two different schedules of docetaxel and prednisone to compare how well they work in treating patients with metastatic prostate cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer | Drug: docetaxel Drug: prednisone | Phase 3 |
OBJECTIVES:
Primary
- Compare the time to treatment failure in patients with hormone-refractory metastatic prostate cancer treated with two different schedules of docetaxel in combination with prednisone.
Secondary
- Compare overall survival of patients treated with these regimens.
- Compare the response rate in patients treated with these regimens.
- Compare the safety of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the need for epoetin beta in patients treated with these regimens.
- Determine the effect of epoetin beta on hemoglobin response rate, transfusion rate, and quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center and WHO performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on days 1 and 15 and oral prednisone once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive docetaxel IV over 1 hour on day 1 and prednisone once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients who experience anemia (hemoglobin < 11 g/dL) receive epoetin beta subcutaneously once weekly during chemotherapy.
Quality of life is assessed at baseline, every 6 weeks during study treatment, at completion of study treatment, and then every 2 months thereafter.
After completion of study treatment, patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 360 patients (180 per treatment arm) will be accrued for this study within 4 years.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 360 participants |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III Trial Comparing Docetaxel Every Third Week to Biweekly Docetaxel Monotherapy in Metastatic Hormone Refractory Prostate Cancer Patients - PROSTY Trial |
| Study Start Date : | August 2005 |
| Actual Primary Completion Date : | May 2009 |
| Actual Study Completion Date : | August 2010 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm I
Patients receive docetaxel IV over 1 hour on days 1 and 15 and oral prednisone once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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Drug: docetaxel
Given in 3- or 4- week courses Drug: prednisone Given in 3- or 4- week courses |
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Experimental: Arm II
Patients receive docetaxel IV over 1 hour on day 1 and prednisone once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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Drug: docetaxel
Given in 3- or 4- week courses Drug: prednisone Given in 3- or 4- week courses |
- Time to treatment failure (TTF)
- Quality of life every 6 weeks until TTF
- Safety
- Overall survival
- Response rate
- Use of epoetin beta
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed adenocarcinoma of the prostate
- Metastatic disease by imaging or clinical examination
- Hormone-refractory disease, defined as prostate-specific antigen (PSA) level > 10 µg/L AND rising between 2 sequential measurements
- Testosterone within castration levels by orchiectomy or medical castration comprising luteinizing hormone-releasing hormone (LHRH) analogues
PATIENT CHARACTERISTICS:
Age
- Over 18
Performance status
- WHO 0-2
Life expectancy
- Not specified
Hematopoietic
- Neutrophil count ≥ 1,500/mm^3
- Hemoglobin ≥ 11.0 g/dL
- Platelet count ≥ 100,000/mm^3
Hepatic
- ALT and AST ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin normal
- Alkaline phosphatase ≤ 6 times ULN (unless due to the presence of extensive bone disease)
- No serious liver disease
Renal
- Creatinine ≤ 1.5 times ULN
Cardiovascular
- No ischemic or thromboembolic cardiac disease
- No myocardial infarction within the past 12 months
- No other serious cardiac disease
Pulmonary
- No pulmonary emboli
Immunologic
- No active infection
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No autoimmune disease, including any of the following:
- Lupus
- Scleroderma
- Rheumatoid polyarthritis
Other
- No active peptic ulcer
- No unstable diabetes mellitus
- No contraindication to corticosteroids
- No other malignant disease within the past 5 years except basalioma
- No functional iron deficiency (i.e., transferrin saturation < 20%) that cannot be treated with iron supplementation
- No other serious illness or medical condition
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 2 months since prior recombinant human epoetin alfa or any other erythropoiesis-stimulating drug
Chemotherapy
- At least 3 weeks since prior estramustine
Endocrine therapy
- See Disease Characteristics
- At least 3 weeks since prior antiandrogen treatment
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Concurrent chemical castration with LHRH allowed provided patient has begun treatment prior to study entry
- No initiation of chemical castration therapy during study treatment
Radiotherapy
- No prior radiotherapy to > 25% of bone marrow
- No prior radioisotope therapy
- Concurrent local palliative radiotherapy for pain allowed
Surgery
- See Disease Characteristics
- At least 4 weeks since prior surgery
Other
- No other prior cytostatic treatment
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Concurrent bisphosphonates allowed provided patient has begun treatment prior to study entry
- No initiation of bisphosphonates during study treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255606
Show 19 study locations
| Principal Investigator: | Pirkko Kellokumpu-Lehtinen | Tampere University Hospital |
| ClinicalTrials.gov Identifier: | NCT00255606 |
| Other Study ID Numbers: |
AVENTIS-FIN-1-2003 CDR0000442891 ( Registry Identifier: PDQ (Physician Data Query) ) FINNISH-URO-OGS-1-2003 PROSTY-FIN-1-2003 ICORG-06-14-Prosty EU-20891 |
| First Posted: | November 21, 2005 Key Record Dates |
| Last Update Posted: | June 26, 2013 |
| Last Verified: | September 2010 |
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adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases Prednisone Docetaxel |
Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal |