Treatment of Hot Flushes Caused by Leuprorelin 11.25 mg in Prostate Adenocarcinoma
Information source: Takeda
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adenocarcinoma, Prostate
Intervention: Cyproterone acetate (Drug); Medroxyprogesterone acetate (Drug); Venlafaxine (Drug); Leuprorelin (Drug); Flutamide (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Takeda Official(s) and/or principal investigator(s): jacques irani, MD, Principal Investigator, Affiliation: Poitiers hospital
Summary
The purpose of this study is to compare the efficacy of three drugs (cyproterone acetate,
medroxyprogesterone acetate and venlafaxine) in the treatment of hot flushes caused by
leuprorelin LP 11. 25 milligram (mg) in participants suffering from prostate cancer.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Percent Change from Randomization in Hot Flushes (HF) Score at Week 4 of Treatment
Secondary outcome: Percent Change from Randomization in HF Frequency at Weeks 4, 8 of Treatment and Last Available ValuePercentage of Participants With More Than 50 percent (%) Decrease in HF Score Percentage of Participants with Complete Regression of hot flushes Percentage of Participants With A Decrease in the Level of HF Complaint Percent Change in HF Score from Randomization at Week 8 of Treatment and Last Available Value Percent Change from Week 4 of treatment in HF Score at Week 8 of Treatment Percent Change from Week 4 of treatment in HF Frequency at Week 8 of Treatment Percentage of Participants Who Wish to Continue the Treatment at the End of Week 10 Percentage of Participants Who Wish to Restart the Treatment at the End of Week 12 European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Participant's Satisfaction About Treatment
Detailed description:
Three drugs will be tested in this study: cyproterone acetate, medroxyprogesterone acetate
and venlafaxine. Cyproterone acetate, medroxyprogesterone acetate and venlafaxine are being
tested to treat men who suffer from hot flushes due to androgen suppression treatment for
prostate cancer. This study will look at the frequency and severity of hot flushes caused by
leuprorelin in participants who will take cyproterone acetate, medroxyprogesterone acetate
or venlafaxine. The study will randomize approximately 311 participants. All participants
will receive 2 injections of leuprorelin 11. 35 mg at Months 0 and 3 along with flutamide
tablets in the first month of treatment to prevent flare-up. After 6 months, eligible
participants will receive third injection of leuprorelin and will be randomly assigned to
one of the three treatment groups—which will remain undisclosed to the participant and study
doctor during the study (unless there is an urgent medical need):
- Cyproterone acetate (Androcur® 50 mg)
- Medroxyprogesterone acetate (Gestoral® 10 mg)
- Venlafaxine (Effexor® LP 37. 5 mg) All participants will be asked to take 2 capsules in
the morning and 1 capsule in the evening for 10 weeks. All participants will be asked
to complete the self-evaluation hot-flushes (HF) questionnaire daily for 12 weeks from
the start of treatment for hot flushes.
This multi-center trial will be conducted in France. The overall time to participate in this
study is approximately 9 months. Participants will make 5 visits to the clinic during the
study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria: - Patient has a histologically proven prostatic adenocarcinoma.
- Patient has been on a gonadotropin releasing hormone (GnRH) agonist treatment for a
duration of at least 1 year.
- Karnofsky index greater than or equal to (>=) 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 a
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.
- Patient for whom risk follow up could not be guaranteed within the conditions
stipulated in the protocol or is unable to complete the self-evaluation
questionnaires.
- Diabetic, or patient with severe progressive disease: kidney, liver, cardiovascular
(especially high uncontrolled BP), psychiatric.
- Has a Thromboembolic history or concomitant thromboembolic disease.
- Patient had hepatocellular insufficiency or hepatic cytolysis (serum glutamic
oxaloacetic transaminase / serum glutamic pyruvate transaminase [SGOT/SGPT] >3 times
laboratory normal range).
- Patient had a contra-indication to one of the study drugs.
- Patient receiving corticotherapy or concomitant prescription for non-selective
monoamine oxidase inhibitors (MAOI), serotonin re-uptake inhibitors, clonidine,
gabapentine, veripride, tibolone or beta-alanine.
- Patient was undergoing medical treatment for a depressive phase or had been treated
for this during the previous 2 years before inclusion.
- Patient with a history of congenital galactosemy, poor absorption of glucose or
galactose syndrome or even a lactase deficiency.
- Patient had another cancer in the 5 previous years excluding basocellular epithelioma
or in situ carcinoma.
Locations and Contacts
Professor Jacques IRANI, Poitiers 86021, France
Additional Information
Starting date: April 2004
Last updated: July 29, 2015
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