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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)


Phase 3
18 Years
80 Years
Not Enrolling
Male
Histologically Confirmed Locally Advanced Prostatic Cancer, no Previous Treatment for the Prostate Cancer

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Trial Information

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)


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.


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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

5 year progression free survival

Outcome Time Frame:

After 5 years median follow up of patients

Safety Issue:

Yes

Principal Investigator

Nicolas MOTTET, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Clinique Mutualiste - Saint-Etienne

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

TAP III/98/032

NCT ID:

NCT01122121

Start Date:

March 2000

Completion Date:

June 2009

Related Keywords:

  • Histologically Confirmed Locally Advanced Prostatic Cancer
  • no Previous Treatment for the Prostate Cancer
  • locally advanced prostatic cancer
  • radiotherapy + hormonotherapy versus hormonotherapy alone
  • Prostatic Neoplasms

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