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

NCT00764166 | Unknown Phase 3

• 1 other identifier: AOM 03108
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of the Prostate

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Every month during 5 years.

Secondary Outcomes (1)

• Secondary endpoints were metastasis-free survival, PSA response (decrease > 50 % of the PSA), overall survival, cancer specific survival, safety and quality of life (QoL).

  Every month during 5 years

Study Arms (2)

1

EXPERIMENTAL

Drug: Docetaxel + hormonal treatment (LH-RH agonist)

2

ACTIVE COMPARATOR

Drug: Hormonal treatment (LH-RH agonist)

Interventions

Docetaxel + hormonal treatment (LH-RH agonist) 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

1

Hormonal treatment (LH-RH agonist) 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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• ARTIC group (oncologists and urologists association): collaborator

Study Sites (1)

Service Oncologie Médicale, Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Related Publications (1)

• 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.

  PMID: 30703190 DERIVED

MeSH Terms

Conditions

Salivary Gland Adenoma, Pleomorphic

Interventions

Docetaxel; Gonadotropin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Stephane Oudard, MD PhD

  European Georges Pompidou Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 1, 2008
• Study Start: June 1, 2003
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2010
• Last Updated: October 1, 2008

Record last verified: 2008-09

Locations

FR (1)