Docetaxel and Prednisone in Treating Patients With Hormone-Refractory Metastatic Prostate Cancer

NCT ID: NCT00255606

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2010-08-31

Brief Summary

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.

Detailed Description

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Study Groups

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.

Group Type: EXPERIMENTAL

docetaxel

Intervention Type: DRUG

Given in 3- or 4- week courses

prednisone

Intervention Type: DRUG

Given in 3- or 4- week courses

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.

Group Type: EXPERIMENTAL

docetaxel

Intervention Type: DRUG

Given in 3- or 4- week courses

prednisone

Intervention Type: DRUG

Given in 3- or 4- week courses

Interventions

docetaxel

Given in 3- or 4- week courses

Intervention Type: DRUG

prednisone

Given in 3- or 4- week courses

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• 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
• 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
• 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
• Concurrent bisphosphonates allowed provided patient has begun treatment prior to study entry

• No initiation of bisphosphonates during study treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Tampere University

OTHER

Sponsor Role: lead

Principal Investigators

Pirkko Kellokumpu-Lehtinen

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

Helsinki University Central Hospital

Helsinki, , Finland

Kainuu Central Hospital

Kajaani, , Finland

Keski-Pohjanmaa Central Hospital

Kokkola, , Finland

Kymenlaakso Central Hospital

Kotka, , Finland

Tampere University Hospital

Lahti, , Finland

Oulu University Hospital

Oulu, , Finland

Satakunta Central Hospital

Pori, , Finland

Tampere University Hospital

Tampere, , Finland

Turku University Central Hospital

Turku, , Finland

Bons Secours Hospital

Cork, , Ireland

Mercy University Hospital

Cork, , Ireland

Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital

Dublin, , Ireland

Mater Misericordiae University Hospital

Dublin, , Ireland

St. James's Hospital

Dublin, , Ireland

Beaumont Hospital

Dublin, , Ireland

Galway University Hospital

Galway, , Ireland

Mid-Western Cancer Centre at Mid-Western Regional Hospital

Limerick, , Ireland

Karlstad Central Hospital

Karlstad, , Sweden

Karolinska University Hospital - Solna

Stockholm, , Sweden

Countries

Finland; Ireland; Sweden

References

Kellokumpu-Lehtinen PL, Harmenberg U, Joensuu T, McDermott R, Hervonen P, Ginman C, Luukkaa M, Nyandoto P, Hemminki A, Nilsson S, McCaffrey J, Asola R, Turpeenniemi-Hujanen T, Laestadius F, Tasmuth T, Sandberg K, Keane M, Lehtinen I, Luukkaala T, Joensuu H; PROSTY study group. 2-Weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer: a randomised, phase 3 trial. Lancet Oncol. 2013 Feb;14(2):117-24. doi: 10.1016/S1470-2045(12)70537-5. Epub 2013 Jan 4.

Reference Type: DERIVED

PMID: 23294853 (View on PubMed)

Hervonen P, Joensuu H, Joensuu T, Ginman C, McDermott R, Harmenberg U, Nyandoto P, Luukkaala T, Hemminki A, Zaitsev I, Heikkinen M, Nilsson S, Luukkaa M, Lehtinen I, Kellokumpu-Lehtinen PL. Biweekly docetaxel is better tolerated than conventional three-weekly dosing for advanced hormone-refractory prostate cancer. Anticancer Res. 2012 Mar;32(3):953-6.

Reference Type: DERIVED

PMID: 22399616 (View on PubMed)

Other Identifiers

CDR0000442891

Identifier Type: REGISTRY

Identifier Source: secondary_id

FINNISH-URO-OGS-1-2003

Identifier Type: -

Identifier Source: secondary_id

PROSTY-FIN-1-2003

Identifier Type: -

Identifier Source: secondary_id

ICORG-06-14-Prosty

Identifier Type: -

Identifier Source: secondary_id

EU-20891

Identifier Type: -

Identifier Source: secondary_id

AVENTIS-FIN-1-2003

Identifier Type: -

Identifier Source: org_study_id