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

NCT00376792 | Unknown Phase 3

• 6 other identifiers: CDR0000456773SPCG-12EUDRACT-2005-002355-40EU-20638SANOFI-AVENTIS-SPCG-12SPCG-ADPRO
• Study Type: interventional
• Target: 396
• Locations: 5 countries
• Sites: 8

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 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.

Conditions

Prostate Cancer

Keywords

stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; adenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (1)

• Prostate-specific antigen (PSA) progression

Secondary Outcomes (4)

• PSA doubling time

• Quality of Life

• Metastasis-free survival

• Overall survival

Interventions

docetaxel DRUG

active surveillance OTHER

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Scandinavian Prostate Cancer Group: lead

Study Sites (8)

Aarhus Universitetshospital - Aarhus Sygehus

Aarhus, DK 8200, Denmark

RECRUITING

Copenhagen County Herlev University Hospital

Copenhagen, DK-2730, Denmark

RECRUITING

Tampere University Hospital

Tampere, 33521, Finland

RECRUITING

Landspitalinn University Hospital

Reykjavik, 125, Iceland

RECRUITING

Ullevaal University Hospital

Oslo, 0407, Norway

RECRUITING

Norwegian University of Science and Technology

Trondheim, N-7005, Norway

RECRUITING

Lund University Hospital

Lund, SE-22185, Sweden

RECRUITING

Malmo University Hospital

Malmo, S-20502, Sweden

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Watchful Waiting; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Goran Ahlgren, MD, PhD

  Skane University Hospital

  STUDY CHAIR

• Per Flodgren, MD, PhD

  Lund University Hospital

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: September 13, 2006
• First Posted: September 15, 2006
• Study Start: October 1, 2005
• Primary Completion: December 1, 2012
• Last Updated: August 26, 2013

Record last verified: 2009-06

Locations

NO (2); SE (2); FI (1); DK (2); IC (1)