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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
  Purpose

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.


Condition Intervention Phase
Adenocarcinoma of the Prostate
 Drug: Docetaxel + hormonal treatment (LH-RH agonist)
Drug: Hormonal treatment (LH-RH agonist)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non-Metastatic High-Risk Prostate Cancer Patients With Biochemical Relapse Only After Local Treatment. A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 254
Study Start Date: June 2003
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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)
Active Comparator: 2 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)

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764166

Locations
France
Service Oncologie Médicale, Hopital Europeen Georges Pompidou
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
ARTIC group (oncologists and urologists association)
Investigators
Principal Investigator: Stephane Oudard, MD PhD European Georges Pompidou Hospital
  More Information

No publications provided

Responsible Party: Aurélie Guimfack, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00764166     History of Changes
Other Study ID Numbers: AOM 03108
Study First Received: September 30, 2008
Last Updated: September 30, 2008
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
PSA (biochemical)
Progression- free Survival
Clinical progress
 Overall survival
Tolerance to the treatment
Quality of Live

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Genital Neoplasms, Male
 Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013