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

NCT ID: NCT00764166

Last Updated: 2008-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2010-11-30

Brief Summary

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.

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

Conditions

Adenocarcinoma of the Prostate

Keywords

PSA (biochemical); Progression- free Survival; Clinical progress; Overall survival; Tolerance to the treatment; Quality of Live

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Docetaxel + hormonal treatment (LH-RH agonist)

Intervention Type: DRUG

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

2

Group Type: ACTIVE_COMPARATOR

Hormonal treatment (LH-RH agonist)

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

ARTIC group (oncologists and urologists association)

UNKNOWN

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Department Clinical Research of Developpement

Principal Investigators

Stephane Oudard, MD PhD

Role: PRINCIPAL_INVESTIGATOR

European Georges Pompidou Hospital

Locations

Service Oncologie Médicale, Hopital Europeen Georges Pompidou

Paris, , France

Countries

France

References

Oudard S, Latorzeff I, Caty A, Miglianico L, Sevin E, Hardy-Bessard AC, Delva R, Rolland F, Mouret L, Priou F, Beuzeboc P, Gravis G, Linassier C, Gomez P, Voog E, Muracciole X, Abraham C, Banu E, Ferrero JM, Ravaud A, Krakowski I, Lagrange JL, Deplanque G, Zylberait D, Bozec L, Houede N, Culine S, Elaidi R. Effect of Adding Docetaxel to Androgen-Deprivation Therapy in Patients With High-Risk Prostate Cancer With Rising Prostate-Specific Antigen Levels After Primary Local Therapy: A Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):623-632. doi: 10.1001/jamaoncol.2018.6607.

Reference Type: DERIVED

PMID: 30703190 (View on PubMed)

Other Identifiers

AOM 03108

Identifier Type: -

Identifier Source: org_study_id