Doxycycline for prostate cancer

Authors
Category Primary study
Registry of TrialsRegistro Público Cubano de Ensayos Clínicos
Year 2021
INTERVENTION: Administration, Oral Bicalutamida Doxycycline Injections, Subcutaneous Intervention Experimental Group (group A): You will receive doxycycline 100 mg every 24 hours for 6 months, plus its standard treatment, which consists of bicalutamide 50 mg orally per day, and leuproline 22.5 mg in subcutaneous application every three months. This dose is less than the maximum previously recommended for chronic treatments such as acne conglobata. The commercial presentation for human use is in 100mg pills, so patients in the experimental group will take 1 pill every 24 hours. Control Group Intervention (group B): You will receive your standard treatment as indicated by current clinical practice (bicalutamide 50mg orally per day, and leuproline 22.5mg in subcutaneous application every three months), plus a bottle of placebo pills that your doctor will provide. monthly in his office with the indication to take 1 pill every 24 hours, for 6 months. Leuprolide Placebos Tablets CONDITION: Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Prostate cancer Prostatic Diseases Prostatic Neoplasms Urogenital Neoplasms PRIMARY OUTCOME: Complete response (25% reduction in serum specific prostate antigen). Measuring time: 3 and 6 months. SECONDARY OUTCOME: Adverse events (according to the common terminology of criteria for adverse events (CTCAE version 3). Measurement time: every week until month 6. Change in the level of prostate‐specific antigen at 6 months of treatment. Quality of life with the questionnaire EORTC QLQ‐PR25 applied at the beginning and at 6 months of treatment. INCLUSION CRITERIA: 1. Clinical and histological diagnosis of excised adenocarcinoma, locally advanced and metastatic prostate cancer. 2. That the treating oncologist consider the patient with metastatic prostate cancer not a candidate for chemotherapy. 3. Patients with metastatic prostate cancer who do not want chemotherapy. 4. Patients who accept, with informed consent, the administration of doxycycline or placebo, in a randomized system
Epistemonikos ID: 575c586cc87f7f7bef127e1c926a511fe49a5322
First added on: Aug 25, 2024