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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

Phase 3
18 Years
70 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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



- 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.


- 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

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.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Prostate-specific antigen (PSA) progression

Safety Issue:


Principal Investigator

Goran Ahlgren, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Malmo University Hospital



Study ID:




Start Date:

October 2005

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms