Leuprorelin Associated With Radiotherapy Versus Leuprorelin Alone in T3 - T4 or pT3 (on Biopsy) N0, M0 Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
Laboratoires Takeda
ClinicalTrials.gov Identifier:
NCT01122121
First received: May 7, 2010
Last updated: May 10, 2010
Last verified: May 2010
  Purpose

the purpose of this study "Leuprorelin associated with radiotherapy versus leuprorelin alone in T3 - T4 or pT3 (on biopsy) N0, M0 prostate cancer" is to assess the possible benefits of the combined treatment on the local or systemic recurrences and on quality of life.


Condition Intervention Phase
Histologically Confirmed Locally Advanced Prostatic Cancer
no Previous Treatment for the Prostate Cancer
Drug: Leuprorelin 11,25 mg SR
Drug: Radiotherapy + hormonotherapy
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: Efficacité et tolérance comparées de la Combinaison radiothérapie-hormonothérapie Adjuvante et de l'hormonothérapie Seule Dans Les Cancers de la Prostate Localement évolués (T3-T4 ou pT3 Biopsiques,N0, M0)

Resource links provided by NLM:


Further study details as provided by Laboratoires Takeda:

Primary Outcome Measures:
  • 5 year progression free survival [ Time Frame: After 5 years median follow up of patients ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to biological progression [ Time Frame: After 5 years median follow up of patients ] [ Designated as safety issue: Yes ]
  • Time to clinical progression [ Time Frame: After 5 years median follow up of patients ] [ Designated as safety issue: Yes ]
  • overall survival [ Time Frame: After 5 years median follow up of patients ] [ Designated as safety issue: Yes ]

Enrollment: 273
Study Start Date: March 2000
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Radiotherapy + hormonotherapy
Leuprorelin 11,25 mg SR (begun within 7 days following randomization, 3 years) + radiotherapy 70 +/- 4 Grays(RT begun within 90 days after 1st leuprorelin injection)
Drug: Radiotherapy + hormonotherapy
Leuprorelin 11,25 mg SR (begun within 7 days following randomization, 3 years) + radiotherapy 70 +/- 4 Grays(RT begun within 90 days after 1st leuprorelin injection)
Hormonotherapy alone
Leuprorelin 11,25 mg SR (begun within 7 days following randomization, 3 years) alone
Drug: Leuprorelin 11,25 mg SR
Leuprorelin 11,25 mg SR (begun within 7 days following randomization, 3 years)

Detailed Description:

STUDY DESIGN :

French multicenter, open, randomized study on 2 parallel groups

First step : treatment during 3 years (excepted disease progression) with Leuprorelin 11,25 mg SR + radiotherapy 70 +/- 4 Grays(begun within 90 days after 1st leuprorelin injection) in the first arm and Leuprorelin 11,25 mg SR alone for the 2nd arm. A visit / 6 months.

Second step : follow-up without treatment during 2 years (excepted disease progression). A visit / 6 months.

Third step : Follow-up out of protocol. 1 data collection / year.

End of study when median follow-up = 5years.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed locally advanced prostatic cancer : T3 or T4 or pT3 (on biopsy), N0, M0
  • Patient whose prostatic cancer has never been treated (excepted transurethral resection for obstructive syndrom)
  • Karnofsky > or = 70
  • Age < 80 years old
  • Life expectancy > 7 years
  • Informed consent given by the patient
  • No abnormal transaminases (> or = 3* normal values) on a recent sample (< 2 months)

Exclusion Criteria:

  • Patient who could not understand the information regarding the study and give his informed written consent, or patient who has refused to sign the informed consent sheet,
  • Patient who could not respect the conditions of the protocol,
  • Patient who has already received a previous treatment for his prostate cancer, excepted transurethral resection for obstructive syndrom,
  • Patient who has been surgically castrated or with a medical history of bilateral suprarenalectomy or hypophysectomy,
  • Patient who had another cancer during the 5 last years excepted a basal cell carcinoma or a carcinoma in situ (excepted bladder),
  • Patient with a ganglionic or metastatic prostate cancer extension suspected on exams,
  • Patient with a serious and unstable pathology,
  • Patient who could not receive a prostatic external irradiation,
  • Patient receiving or who has received another experimental treatment during the 3 last months,
  • Patient with a hepatic insufficiency or abnormal transaminases (> or = 3* normal values).
  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: NCT01122121

Locations
France
Clinique Mutualiste
Saint-etienne, France, 42013
Sponsors and Collaborators
Laboratoires Takeda
Investigators
Principal Investigator: Nicolas MOTTET, Dr Clinique Mutualiste - Saint-Etienne
Principal Investigator: Pierre RICHAUD, Dr Institut BERGONIÉ, Centre Régional de Lutte contre le Cancer, Bordeaux
Principal Investigator: Michel PENEAU, Dr Martinique
Principal Investigator: Jean-Jacques MAZERON, Pr Groupe Hospitalier PITIE-SALPETRIERE, Paris
  More Information

No publications provided

Responsible Party: Dcoteur Mehemed OUZID, Responsable des Opérations Cliniques, Laboratoires TAKEDA
ClinicalTrials.gov Identifier: NCT01122121     History of Changes
Other Study ID Numbers: TAP III/98/032
Study First Received: May 7, 2010
Last Updated: May 10, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Laboratoires Takeda:
locally advanced prostatic cancer
radiotherapy + hormonotherapy versus hormonotherapy alone

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 21, 2014