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

May 7, 2010
May 10, 2010
March 2000
December 2008   (final data collection date for primary outcome measure)
5 year progression free survival [ Time Frame: After 5 years median follow up of patients ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01122121 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Leuprorelin Associated With Radiotherapy Versus Leuprorelin Alone in T3 - T4 or pT3 (on Biopsy) N0, M0 Prostate Cancer
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)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Histologically Confirmed Locally Advanced Prostatic Cancer
  • no Previous Treatment for the Prostate Cancer
  • Drug: Leuprorelin 11,25 mg SR
    Leuprorelin 11,25 mg SR (begun within 7 days following randomization, 3 years)
  • 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)
  • 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)
    Intervention: Drug: Radiotherapy + hormonotherapy
  • Hormonotherapy alone
    Leuprorelin 11,25 mg SR (begun within 7 days following randomization, 3 years) alone
    Intervention: Drug: Leuprorelin 11,25 mg SR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
273
June 2009
December 2008   (final data collection date for primary outcome measure)

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).
Male
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01122121
TAP III/98/032
Yes
Dcoteur Mehemed OUZID, Responsable des Opérations Cliniques, Laboratoires TAKEDA
Laboratoires Takeda
Not Provided
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
Laboratoires Takeda
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP