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Intermittent Hormonal Therapy With Leuproreline and Flutamide in the Treatment of Stage D2 or TxNxM1b,c

This study has been completed.
Sponsor:
Information provided by:
Laboratoires Takeda
ClinicalTrials.gov Identifier:
NCT00817739
First received: January 5, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

This study is aimed at evaluating the effects of intermittent hormonal treatment with complete androgen suppression (Leuprorelin 3,75 mg SR and Flutamide) in patients presenting with stage D2 or Tx Nx M1 ≠ M1a metastatic prostrate cancer, with a PSA level 5-fold higher than normal (PSA ≥ 20 ng/ml, as quantitated by the Hybritech radioimmunoassay) and with a subsequent decline to normal (PSA <4 ng/ml) during the initial 6 months of induction treatment. The results will be compared with those obtained after continuous hormonal therapy with complete androgen suppression.


Condition Intervention Phase
Prostate Cancer
Drug: Leuprorelin injection
Phase 2
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: Intermittent Hormonal Therapy With Leuproreline (3.75 mg SR) and Flutamide in the Treatment of Stage D2 or Tx Nx M1 Different From M1a

Resource links provided by NLM:


Further study details as provided by Laboratoires Takeda:

Enrollment: 341
Study Start Date: December 1996
Study Completion Date: December 2008
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Group A patients will receive a continuous complete androgen suppression therapy by leuproreline 3.75mg SR (1 subcutaneous injection each 28 days) and flutamide (1 tablet, 3 times per day), until the appearance of signs of disease progression or study end.
Drug: Leuprorelin injection

The study comprises two therapeutic phases:

A 6 month induction phase with complete androgen suppression. This phase involves patients meeting the preselection criteria.

A data processing run per complete androgen suppression according to two methods, continuous or intermittent, for the patients satisfying the criteria of selection of the study and which will thus be randomized The selected patients will be randomized centrally in two parallel groups at the time of inclusion

2
Group B patients will receive an intermittent complete androgen suppression therapy by leuproreline 3.75 mg SR (1 subcutaneous injection each 28 days) and flutamide (1 tablet, 3 times per day), until the study end or the appearance of signs of disease progression under treatment
Drug: Leuprorelin injection

The study comprises two therapeutic phases:

A 6 month induction phase with complete androgen suppression. This phase involves patients meeting the preselection criteria.

A data processing run per complete androgen suppression according to two methods, continuous or intermittent, for the patients satisfying the criteria of selection of the study and which will thus be randomized The selected patients will be randomized centrally in two parallel groups at the time of inclusion


  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed metastatic cancer of the prostate (stage D2 or TxNxM1b,c) with measurable bone or visceral metastases
  • Metastatic cancer of the prostate requiring first-line therapy
  • Preassessment PSA 5 fold or higher than the standard level set by central laboratory
  • ECOG preformance status < or = 2
  • Transaminases < 2.25 fold higher than the standard levels set by the central laboratory
  • Anticipated life expectancy > 9 months
  • written informed consent given to participate and collaborate in the study

Exclusion Criteria:

  • Patient refused to sign the informed consent form or is likely to be uncooperative or not to comply with the obligations set out in the study protocol
  • patient has received prior hormonal (and neoadjuvant) treatment prompting medical castration or has undergone surgical castration
  • patient has undergone bilateral suprarenalectomy or hypophysectomy Patient has undergone cancer within the past 5 years Patient has serious unstable progressive disease Receiving or having received another experimental treatment within 3 months prior inclusion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817739

Sponsors and Collaborators
Laboratoires Takeda
Investigators
Principal Investigator: Nicolas MOTTET, MD Clinique Mutualiste de saint-etienne
  More Information

No publications provided

Responsible Party: Mehemed OUZID, Laboratoires TAKEDA
ClinicalTrials.gov Identifier: NCT00817739     History of Changes
Other Study ID Numbers: TAP IIb/95/022 - EC210
Study First Received: January 5, 2009
Last Updated: January 5, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Laboratoires Takeda:
Prostate cancer is the second most common cancer in France
treatment : Leuprorelin, a medical castration by LHRH agonist

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Flutamide
Androgen Antagonists
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014