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Status:

UNKNOWN

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

Lead Sponsor:

Scandinavian Prostate Cancer Group

Conditions:

Prostate Cancer

Eligibility:

MALE

18-70 years

Phase:

PHASE3

Brief Summary

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 afte...

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 treate...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    October 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    396 Patients enrolled

    Trial Details

    Trial ID

    NCT00376792

    Start Date

    October 1 2005

    Last Update

    August 26 2013

    Active Locations (8)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (8 locations)

    1

    Aarhus Universitetshospital - Aarhus Sygehus

    Aarhus, Denmark, DK 8200

    2

    Copenhagen County Herlev University Hospital

    Copenhagen, Denmark, DK-2730

    3

    Tampere University Hospital

    Tampere, Finland, 33521

    4

    Landspitalinn University Hospital

    Reykjavik, Iceland, 125