Doxycycline for prostate cancer

Phase 2

Recruiting

• Conditions: Prostate cancer; Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Prostatic Diseases; Genital Diseases, Male; Male Urogenital Diseases

• Registration Number: RPCEC00000367
• Lead Sponsor: Medical School of the University of Colima, Mexico

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-11
• Study Completion: 2022-07-01
• Results First Posted: 2022-12-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 40

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

Exclusion Criteria

1. Diagnosis of another primary cancer other than prostate.
2. Alcoholism and / or drug addiction.
3. Allergic to tetracyclines.
4. Gastrointestinal ulcer.
5. Inflammatory bowel disease.
6. Diagnosis of ischemic heart disease.
7. Liver disease.
8. Kidney disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete response (25% reduction in serum specific prostate antigen). Measuring time: 3 and 6 months.

Secondary Outcome Measures

Name	Time	Method
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.