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Non-Metastatic High-Risk Prostate Cancer Patients With Biochemical Relapse Only After Local Treatment. A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel

Phase 3
18 Years
Open (Enrolling)
Adenocarcinoma of the Prostate

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Trial Information

Non-Metastatic High-Risk Prostate Cancer Patients With Biochemical Relapse Only After Local Treatment. A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel

Docetaxel was shown to be active in metastatic hormone-refractory prostate cancer (PC) in
phase III trials (1-2). It is likely to demonstrate a substantial role in the management of
early-stage PC patients in the neoadjuvant and adjuvant settings, where clinical trials are
underway.•53% of all men who undergo radical prostatectomy will develop prostate-specific
antigen (PSA) elevations in the 10 years following surgery, with approximately 77% of these
recurrences occurring within the first 2 years.A prospective, multicenter, national,
randomized, two-arm, phase III study comparing hormonal treatment (LH-RH agonist alone) with
or without docetaxel was designed to evaluate the interest of chemotherapy in non-metastatic
prostate cancer patients at high risk of systemic recurrence after initial treatment
(radical prostatectomy or radiotherapy).

1. PETRYLAK DP, et al: Docetaxel and estramustine compared with mitoxantrone and
prednisone for advanced refractory prostate cancer. N Engl J Med 351:1513-1520, 2004

2. TANNOCK IF, de Wit R, Berry WR, et al: Docetaxel plus prednisone or mitoxantrone plus
prednisone for advanced prostate cancer. N Engl J Med 351:1502-1512, 2004

Inclusion Criteria:

- Histologically documented adenocarcinoma of the prostate

- Previous treatment with either radical prostatectomy or radiation therapy

- Salvage radiotherapy for local relapse allowed

- Neoadjuvant or per radiotherapy Hormonal therapy allowed in case of more than 6
months free-interval before first rising PSA

- Life expectancy of more than 12 months

- Non metastatic disease documented by imaging including radionuclide bone scan

- ECOG performance status 0-1

- ANC > 1,500/mm3

- Platelet counts > 100,000/mm3

- SGOT and/or SGPT may be up to 2.5 x ULN

Patients at high risk of biological relapse defined by:

- Gleason > 8

- PSA-DT < 6 months

- Positive surgical margins

- PSA velocity > 0.75 ng/mL/year

- Pathological pelvic lymph nodes involvement (pN+)

- Time from initial treatment until inclusion < 12 months

Exclusion Criteria:

- Prior chemotherapy by taxanes and estramustine phosphate

- Documented local recurrence of prostate cancer or documented metastatic disease

- History of other malignancy within the last 5 years other than curatively treated
basal cell carcinoma of the skin

- Active infection

- Significant cardiac disease, angina pectoris or myocardial infarction within twelve

- Clinically significant neuropathy

- Medical condition requiring the use of concomitant corticosteroids

- Prohibited concomitant therapy with experimental drug.

- Participation in another clinical trial for the period < 30 days

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint was the PSA (biochemical) progression-free survival (PFS) of high-risk metastasis-free PC patients, treated with LH-RH agonist for one year with or without docetaxel after prior radical prostatectomy (RP) or radiotherapy (RT).

Outcome Time Frame:

Every month during 5 years.

Safety Issue:


Principal Investigator

Stephane Oudard, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

European Georges Pompidou Hospital


France: Ministry of Health

Study ID:

AOM 03108



Start Date:

June 2003

Completion Date:

November 2010

Related Keywords:

  • Adenocarcinoma of the Prostate
  • PSA (biochemical)
  • Progression- free Survival
  • Clinical progress
  • Overall survival
  • Tolerance to the treatment
  • Quality of Live
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms