Know Cancer

or
forgot password

A Multicentric, Multinational (China and Russia), Randomised, Open, Controlled Study of Immediate 9 Months Adjuvant Hormone Therapy With Triptorelin 11.25 mg Versus Active Surveillance After Radical Prostatectomy in High Risk Prostate Cancer Patients


Phase 4
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

A Multicentric, Multinational (China and Russia), Randomised, Open, Controlled Study of Immediate 9 Months Adjuvant Hormone Therapy With Triptorelin 11.25 mg Versus Active Surveillance After Radical Prostatectomy in High Risk Prostate Cancer Patients


This trial is a phase IV (in Russia and China) as approved indication is locally advanced or
metastatic prostate cancer in both countries.


Inclusion Criteria:



- Histopathologically confirmed adenocarcinoma of the prostate

- Radical Prostatectomy with curative intent performed no more than 8 weeks before
randomisation

- High risk criteria of disease progression, defined as follows:

Gleason score ≥8 on prostatectomy specimen, and/or Pre RP PSA level ≥20 ng/mL, and/or
Primary tumour stage 3a (pT3a) (with any PSA level and any Gleason score)

- Post-RP PSA levels ≤0.2 ng/mL at 6 weeks

Exclusion Criteria:

- Evidence of lymph nodes or distant metastasis

- Positive margins

- Evidence of any other malignant disease, not treated with a curative intent

- Had surgical castration

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Biochemical Relapse-Free Survival (BRFS)

Outcome Description:

BRFS defined as period of time from randomisation to time of Biochemical Relapse (BR). BR is defined as increased prostate specific antigen (PSA) >0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later

Outcome Time Frame:

Every 3 months, up to 5 years

Safety Issue:

No

Principal Investigator

Patrick Cabri, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Ipsen

Authority:

Russia: Ministry of Health of the Russian Federation

Study ID:

A-38-52014-194

NCT ID:

NCT01753297

Start Date:

December 2012

Completion Date:

December 2017

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location