Phenamate in the treatment of prostate cancer

Phase 2

• Conditions: Prostate cancer with resistance to castration.; Prostate cancer; Prostatic Neoplasms, Castration-Resistant; Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Prostatic Diseases; Genital Diseases, Male; Male Urogenital Diseases

• Registration Number: RPCEC00000248
• Lead Sponsor: Medical School of the University of Colima, Mexico

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-15
• Study Completion: 2021-11-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Clinical and histological diagnosis of castration-resistant prostate cancer.
2. That the treating oncologist considers that the administration of Docetaxel is the feasible and appropriate treatment for the patient (for control group 1 and experimental group 1).
3. Functional status ECOG 0 to 2.
4 Patients with no history of hepatic impairment or renal impairment (creatinine clearance should be greater than 60 milliliters / minute).
5. Sign written informed consent of the patient.

Exclusion Criteria

1. ECOG 3 or greater
2. Diagnosis of second primary cancer.
3. Patients with uncontrolled arterial hypertension
4. Creatinine clearance less than 60 milliliters per minute
5. Leukocytes less than 3000 cells / microliter or platelet count less than 100,000 cells / microliter 6. Leukocytes greater than 10,000 cells / microliter or showing data Of systemic infection
7. Blood hemoglobin less than 9gr / deciliter 8. Alcoholism and / or drug addiction
9. Gastrointestinal ulcer
10. Inflammatory bowel disease
11. Diagnosis of ischemic heart disease
12. Other pathologies at the discretion of the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete response (RECIST 1.1). Measuring time: 3 and 6 months.

Secondary Outcome Measures

Name	Time	Method
Adverse Events (According to Common Terminology of Criteria for Adverse Events (CTCAE version 3). Measurement time: Every week until month 6.<br>Change in the level of the specific prostate antigen at 6 months of treatment.<br>Change in the Mini-Mental State Examination (MMSE) score at 6 months of treatment.<br>Changes in the levels of genetic expression in prostate cancer tissue at 6 months of treatment