Adenocarcinoma, Prostate Clinical Trial
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
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.
| Status | Completed |
| Enrollment | 311 |
| Est. completion date | December 2007 |
| Est. primary completion date | December 2007 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Professor Jacques IRANI | Poitiers |
| Lead Sponsor | Collaborator |
|---|---|
| Takeda |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Randomization (Month 6) and Week 4 of treatment (Month 7) | No |
| Secondary | 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. | Randomization (Month 6), Weeks 4 and 8 of treatment (Months 7 and 8, respectively) and last available value (Month 7 or 8) | No |
| Secondary | 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. | Week 4 of treatment | No |
| Secondary | 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. | Week 4 of treatment | No |
| Secondary | 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. | Weeks 4 and 8 of treatment and Week 12 after the start of treatment | No |
| Secondary | 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. | Randomization, Week 8 of treatment, and last available value (Month 7 or 8) | No |
| Secondary | 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. | Weeks 4 and 8 of treatment | No |
| Secondary | 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. | Weeks 4 and 8 of treatment | No |
| Secondary | 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. | Weeks 8 and 12 after the start of treatment | No |
| Secondary | 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. | Week 12 after the start of treatment | No |
| Secondary | 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. | Baseline (Month 0), randomization (Month 6), Weeks 4 and 8 of treatment, Week 12 after the start of treatment | No |
| Secondary | 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. | Week 4, 8 of treatment, and Week 12 after the start of treatment | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02987829 -
Phase 1/2A Study of TRC253, an Androgen Receptor Antagonist, in Metastatic Castration-resistant Prostate Cancer Patients
|
Phase 1/Phase 2 |