A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel (RisingPSA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
ARTIC group (oncologists and urologists association)
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00764166
First received: September 30, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted

September 30, 2008
September 30, 2008
June 2003
November 2009   (final data collection date for primary 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). [ Time Frame: Every month during 5 years. ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Secondary endpoints were metastasis-free survival, PSA response (decrease > 50 % of the PSA), overall survival, cancer specific survival, safety and quality of life (QoL). [ Time Frame: Every month during 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel
Non-Metastatic High-Risk Prostate Cancer Patients With Biochemical Relapse Only After Local Treatment. A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel

The primary objective was to evaluate 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).

The study was powered at 80% to detect a 25% improvement in biochemical PFS for a total sample size estimated at 252 patients, with a two-sided type I error rate of 5% (non-parametric methods.

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Adenocarcinoma of the Prostate
  • Drug: Docetaxel + hormonal treatment (LH-RH agonist)

    Docetaxel will be administered:

    • To D1 of every cycle in the dose of 70 mg/m²,
    • Perfusion IV of 60 minutes diluted in 250 ml with physiological serum or with serum glucoside from a peripheral or central vein, Every 3 weeks during 6 cycles (except when unacceptable tolerance).

    Triptorelin was given by injection for 4 times every 3 months Bicalutamide was given at the same time with LH-RH agonist for 3 weeks ; taken orally

    Other Name: Docetaxel + hormonal treatment (LH-RH agonist)
  • Drug: Hormonal treatment (LH-RH agonist)
    Triptorelin was given by injection for 4 times every 3 months. Bicalutamide given at the same time with LH-RH agonist for 3 weeks ; taken orally.
    Other Name: Hormonal treatment (LH-RH agonist)
  • Experimental: 1
    Intervention: Drug: Docetaxel + hormonal treatment (LH-RH agonist)
  • Active Comparator: 2
    Intervention: Drug: Hormonal treatment (LH-RH agonist)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
254
November 2010
November 2009   (final data collection date for primary outcome measure)

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 months
  • 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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00764166
AOM 03108
No
Aurélie Guimfack, Department Clinical Research of Developpement
Assistance Publique - Hôpitaux de Paris
ARTIC group (oncologists and urologists association)
Principal Investigator: Stephane Oudard, MD PhD European Georges Pompidou Hospital
Assistance Publique - Hôpitaux de Paris
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP