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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
311
Cyproterone acetate tablet-in-capsule.
Medroxyprogesterone acetate tablet-in-capsule.
Venlafaxine capsule.
Professor Jacques IRANI
Poitiers, Poitiers, France
Percent Change from Randomization in Hot Flushes (HF) Score at Week 4 of Treatment
The change is calculated as follows: \[(HF score at Week 4 of treatment - HF score at randomization)/HF score at randomization\]\*100. The calculation of the HF score will be done as follows: a coefficient is allocated to each severity grade, it varies from 1 to 4 (1: slight; 2: moderate; 3: severe; 4: very severe), and the calculation of the daily score is equal to the sum of the daily instances of hot flushes multiplied by their severity coefficient. The score calculated at randomization and Week 4 of treatment will be the average of the scores recorded in the preceding week. The score range will depend upon the frequency of hot flushes, and higher score signifies higher severity of hot flushes.
Time frame: Randomization (Month 6) and Week 4 of treatment (Month 7)
Percent Change from Randomization in HF Frequency at Weeks 4, 8 of Treatment and Last Available Value
The change is calculated as follows: \[(HF frequency at specified Week of treatment - HF frequency at randomization)/HF score at randomization\]\*100.
Time frame: Randomization (Month 6), Weeks 4 and 8 of treatment (Months 7 and 8, respectively) and last available value (Month 7 or 8)
Percentage of Participants With More Than 50 percent (%) Decrease in HF Score
The percentage of participants with at least 50 % improvement in HF score after 4 weeks of treatment compared to randomization will be calculated. The calculation of the HF score will be done as follows: a coefficient is allocated to each severity grade, it varies from 1 to 4 (1: slight; 2: moderate; 3: severe; 4: very severe), and the calculation of the daily score is equal to the sum of the daily instances of hot flushes multiplied by their severity coefficient. The score range will depend upon the frequency of hot flushes, and higher score signifies higher severity of hot flushes. The score calculated at randomization and Week 4 of treatment will be the average of the scores recorded in the preceding week.
Time frame: Week 4 of treatment
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Leuprorelin injection.
Flutamide tablet
Cyproterone acetate, medroxyprogesterone acetate or venlafaxine placebo-matching capsule.
Percentage of Participants with Complete Regression of hot flushes
Complete regression at Week 4 of treatment signifies complete disappearance of hot flushes upon 4 weeks of treatment.
Time frame: Week 4 of treatment
Percentage of Participants With A Decrease in the Level of HF Complaint
Decrease (improvement) in the level of complaint regarding hot flushes will be assessed compared to randomization. Participants' level of complaints about hot flushes was recorded at each visit of the study. The change in the level of complaints will be classified as degradation, non-change or improvement.
Time frame: Weeks 4 and 8 of treatment and Week 12 after the start of treatment
Percent Change in HF Score from Randomization at Week 8 of Treatment and Last Available Value
The change is calculated as follows: \[(HF score at specified Week of treatment - HF score at randomization)/HF score at randomization\]\*100. The calculation of the HF score will be done as follows: a coefficient is allocated to each severity grade, it varies from 1 to 4 (1: slight; 2: moderate; 3: severe; 4: very severe), and the calculation of the daily score is equal to the sum of the daily instances of hot flushes multiplied by their severity coefficient. The score range will depend upon the frequency of hot flushes, and higher score signifies higher severity of hot flushes. The score calculated at randomization and Week 8 of treatment will be the average of the scores recorded in the preceding week.
Time frame: Randomization, Week 8 of treatment, and last available value (Month 7 or 8)
Percent Change from Week 4 of treatment in HF Score at Week 8 of Treatment
The change is calculated as follows: \[(HF score at Week 8 of treatment - HF score at Week 4 of treatment)/HF score at Week 4 of treatment\]\*100. The calculation of the HF score will be done as follows: a coefficient is allocated to each severity grade, it varies from 1 to 4 (1: slight; 2: moderate; 3: severe; 4: very severe), and the calculation of the daily score is equal to the sum of the daily instances of hot flushes multiplied by their severity coefficient. The score range will depend upon the frequency of hot flushes, and higher score signifies higher severity of hot flushes. The score calculated at Weeks 4 and 8 of treatment will be the average of the scores recorded in the preceding week.
Time frame: Weeks 4 and 8 of treatment
Percent Change from Week 4 of treatment in HF Frequency at Week 8 of Treatment
The change is calculated as follows: \[(HF frequency at Week 8 of treatment - HF frequency at Week 4 of treatment)/HF score at Week 4 of treatment\]\*100.
Time frame: Weeks 4 and 8 of treatment
Percentage of Participants Who Wish to Continue the Treatment at the End of Week 10
Participants will be asked at Week 8 and 12 visits if they would like to continue the study treatment beyond the protocol-specified 10 weeks of treatment.
Time frame: Weeks 8 and 12 after the start of treatment
Percentage of Participants Who Wish to Restart the Treatment at the End of Week 12
Participants will be asked at Week 12 visit if they would like to restart the study treatment which ended after 10 weeks.
Time frame: Week 12 after the start of treatment
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
EORTC QLQ-C30: includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions uses 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions uses 7-point scale (1 'very poor' to 7 'Excellent'). Scores are averaged and transformed to 0-100 scale; for the 5 functional scales and the global quality-of-life scale, a higher score represents a better level of functioning. For the symptom-oriented scales and items, a higher score corresponds to a higher level of symptoms.
Time frame: Baseline (Month 0), randomization (Month 6), Weeks 4 and 8 of treatment, Week 12 after the start of treatment
Participant's Satisfaction About Treatment
Participant's satisfaction is assessed by asking them how they would rate the treatment efficacy as not very effective, moderately effective and very effective at 4, 8 weeks of treatment and 12 weeks after the start of treatment.
Time frame: Week 4, 8 of treatment, and Week 12 after the start of treatment