Docetaxel Compared With Observation in Treating Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00376792
First received: September 13, 2006
Last updated: August 23, 2013
Last verified: June 2009
  Purpose

RATIONALE: 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. Giving docetaxel after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving docetaxel after surgery is more effective than observation in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying docetaxel to see how well it works compared with observation in treating patients who have undergone radical prostatectomy for prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: docetaxel
Other: active surveillance
Procedure: adjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Randomized Phase III Trial of Six Cycles of Docetaxel Versus Surveillance After Radical Prostatectomy in High Grade Prostate Cancer Patients With Margin Positive T2 or T3 Tumours

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Prostate-specific antigen (PSA) progression [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PSA doubling time [ Designated as safety issue: No ]
  • Quality of Life [ Designated as safety issue: No ]
  • Metastasis-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 396
Study Start Date: October 2005
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Compare time to prostate-specific antigen (PSA) progression in patients with margin-positive tumors after undergoing radical prostatectomy for high-grade prostate cancer treated with docetaxel versus observation.

Secondary

  • Compare PSA doubling time in patients treated with these regimens.
  • Compare quality of life of these patients.
  • Compare overall and metastasis-free survival of patients treated with these regimens.

OUTLINE: This is a prospective, open-label, randomized, multicenter study. Patients are stratified according to participating center and tumor stage (pT2 vs pT3). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, directly after and 6 months after completing study treatment, and then annually thereafter.

  • Arm II: Patients undergo observation until PSA progression (defined as PSA ≥ 0.5 ng/mL) Quality of life is assessed at baseline, week 19, and annually thereafter.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 396 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate meeting one of the following criteria after undergoing radical prostatectomy:

    • pT2 with Gleason score 4+3 or 8-10 and positive margins in the radical prostatectomy specimen
    • Any pT3a tumor with Gleason score ≥ 4+3
    • pT3b tumor with Gleason score ≥ 7
  • Negative lymph nodes at histological examination (N0)
  • Patients with a preoperative prostate-specific antigen (PSA) ≥ 10.0 ng/mL should have undergone a lymph node dissection
  • Postoperative PSA must be < 0.5 ng/mL
  • Considered at high risk for recurrent disease
  • No metastatic (M0) disease

    • Negative bone scan

PATIENT CHARACTERISTICS:

  • WHO/ECOG performance status 0-1
  • Hemoglobin ≥ 11.0 g/dL
  • Neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 150,000/mm³
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin normal
  • AST and ALT ≤ 1.5 times ULN
  • Alkaline phosphatase < 1.5 times ULN
  • No active untreated infectious disease (e.g., tuberculosis or methicillin-resistant Staphylococcus aureus)
  • No active gastric ulcer
  • No known hypersensitivity to polysorbate 80
  • No symptomatic peripheral neuropathy ≥ grade 2
  • No myocardial infarction within the past 6 months
  • No other unstable cardiovascular disease within the past 6 months
  • No other serious illness or medical condition
  • No altered psychological or physical state that would preclude study compliance
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior hormonal therapy (e.g., luteinizing hormone-releasing hormone analogues and/or antiandrogens) affecting prostate cancer cells
  • No prior radiotherapy to the pelvis
  • No prior chemotherapy
  • More than 6 months since prior systemic corticosteroids
  • No other concurrent anticancer therapy or investigational drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376792

Locations
Denmark
Aarhus Universitetshospital - Aarhus Sygehus Recruiting
Aarhus, Denmark, DK 8200
Contact: Michael Borre, MD, PhD, DMsci    45-89-495-566      
Copenhagen County Herlev University Hospital Recruiting
Copenhagen, Denmark, DK-2730
Contact: Lisa Sengelov, MD, PhD    45-44-884-488    lise@herlevhosp.kbhamt.dk   
Finland
Tampere University Hospital Recruiting
Tampere, Finland, 33521
Contact: Pirkko Kellokumpu-Lehtinen    358-3-247-3227    pirkko-liisa.kellokumpu-lehtinen@uta.fi   
Iceland
Landspitalinn University Hospital Recruiting
Reykjavik, Iceland, 125
Contact: Asgerdur Sverrisdottir, MD    354-543-1000    asgerds@landspitali.is   
Norway
Ullevaal University Hospital Recruiting
Oslo, Norway, 0407
Contact: Jon R. Iversen, MD    47-22-119-310    joiv@uus.no   
Norwegian University of Science and Technology Recruiting
Trondheim, Norway, N-7005
Contact: Anders Angelsen, MD, PhD    47-73-868-000      
Sweden
Lund University Hospital Recruiting
Lund, Sweden, SE-22185
Contact: Per Flodgren, MD, PhD    46-46-177-520      
Malmo University Hospital Recruiting
Malmo, Sweden, S-20502
Contact: Goran Ahlgren, MD, PhD    46-40-33-3754    goran.ahlgren@skane.se   
Sponsors and Collaborators
Scandinavian Prostate Cancer Group
Investigators
Study Chair: Goran Ahlgren, MD, PhD Malmo University Hospital
Investigator: Per Flodgren, MD, PhD Lund University Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00376792     History of Changes
Other Study ID Numbers: CDR0000456773, SPCG-12, EUDRACT-2005-002355-40, EU-20638, SANOFI-AVENTIS-SPCG-12, SPCG-ADPRO
Study First Received: September 13, 2006
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014