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Efficacy and Tolerance of Cyproterone Acetate Versus Medroxyprogesterone Acetate Versus Venlafaxine LP in the Treatment of Hot Flushes Caused by Leuprorelin 11.25 mg in Patients Treated for a Prostate Adenocarcinoma


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Efficacy and Tolerance of Cyproterone Acetate Versus Medroxyprogesterone Acetate Versus Venlafaxine LP in the Treatment of Hot Flushes Caused by Leuprorelin 11.25 mg in Patients Treated for a Prostate Adenocarcinoma


Primary objective:

To compare the efficacy of 3 drugs (cyproterone acetate, medroxyprogesterone acetate,
venlafaxine) in the treatment of hot flushes caused by leuprorelin LP 11.25 mg in patients
suffering from prostate cancer: frequency and severity of hot flushes.

Secondary objectives:

To evaluate in each treatment group:

- the tolerance profile of the study drugs,

- the impact of the treatment on the quality of life of patients and their satisfaction,

- the change in the frequency and severity of hot flushes after 4 and 8 weeks of
treatment,

- the proportion of patients who wish to continue treatment after the end of the study.


Inclusion Criteria:



- Patient has a histologically proven prostatic adenocarcinoma,

- Patient has been on a GnRH agonist treatment for a duration of at least 1 year,

- Karnofsky index >70%,

- Patient who, after having been clearly informed, has given his written consent to
participate in the study.

Exclusion Criteria:

- Patient included in a therapeutic trial in the 3 months preceding the inclusion
visit,

- Prescription of agonist planned in the context of neo-adjuvant hormonotherapy,

- Patient has symptomatic bone metastases,

- Patient already treated with hormonotherapy for his prostate cancer or has received
an hormonal treatment other than a GnRH agonist for this cancer (apart from
palliative care of flare-up with anti-androgens),

- Patient is unable to understand the information regarding the study provided to him,
of giving his consent or who has refused to sign the informed consent sheet,

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

HOT FLUSHES score in week 4 of treatment after randomisation (variation in average score compared with evaluation at randomisation visit V1, expressed as a percentage).

Outcome Time Frame:

in week 4 of treatment after randomisation

Safety Issue:

No

Principal Investigator

jacques irani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Poitiers hospital

Authority:

France: Institutional Ethical Committee

Study ID:

F-LEU-100

NCT ID:

NCT01011751

Start Date:

April 2004

Completion Date:

December 2007

Related Keywords:

  • Prostate Cancer
  • hot flushes
  • leuprorelin 11.25 mg
  • Cyproterone acetate
  • Medroxyprogesterone acetate
  • Venlafaxine
  • Efficacy
  • Tolerance
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms
  • Hot Flashes

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