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

Prostate Cancer Clinical Trial

Official title:

A Phase III Trial Comparing Docetaxel Every Third Week to Biweekly Docetaxel Monotherapy in Metastatic Hormone Refractory Prostate Cancer Patients - PROSTY Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255606
• Other study ID #: AVENTIS-FIN-1-2003
• Secondary ID: CDR0000442891FIN
• Status: Completed
• Phase: Phase 3
• First received: November 18, 2005
• Last updated: June 25, 2013
• Start date: August 2005
• Est. completion date: August 2010

Study information

• Verified date: September 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: August 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• docetaxel
Given in 3- or 4- week courses
• prednisone
Given in 3- or 4- week courses

Locations

Country	Name	City	State
Finland	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
Ireland	Bons Secours Hospital	Cork
Ireland	Mercy University Hospital	Cork
Ireland	Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital	Dublin
Ireland	Beaumont Hospital	Dublin
Ireland	Mater Misericordiae University Hospital	Dublin
Ireland	St. James's Hospital	Dublin
Ireland	Galway University Hospital	Galway
Ireland	Mid-Western Cancer Centre at Mid-Western Regional Hospital	Limerick
Sweden	Karlstad Central Hospital	Karlstad
Sweden	Karolinska University Hospital - Solna	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
University of Tampere

Countries where clinical trial is conducted

Finland,  Ireland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to treatment failure (TTF)			No
Secondary	Quality of life every 6 weeks until TTF			No
Secondary	Safety			Yes
Secondary	Overall survival			No
Secondary	Response rate			No
Secondary	Use of epoetin beta			No