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Doxycycline for prostate cancer
Updated by SSA on 15/06/2021 - 9:33am
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General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Acronym of Public Title:
DOXCAPROST
Scientific title:
New therapeutic scheme for patients with advanced prostate cancer: phase II clinical trial using doxycycline combined with antiandrogen treatment.
Acronym of Scientific Title:
DOXCAPROST
Secondary indentifying numbers:
Not applicable
Issuing authority of the secondary identifying numbers:
Not applicable
Primary sponsor:
Medical School of the University of Colima, Mexico
Secondary sponsor:
Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico
Mexico Mexican Social Security Institute.
Source(s) of monetary or material support:
Mexico Mexican Social Security Institute
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Only approved by Ethics Committees
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
José
Last name:
Guzman Esquivel
Medical Specialty :
Urology
Affiliation:
Mexican institute of social security, General Hospital of Zone 1
Postal address:
Lapislazuli Avenue No 250, Colonia El Haya
City:
Villa de Alvarez, Colima
Country:
Mexico
Zip Code:
28984
Telephone:
+52-3123163460
Email address:
pepeguzman_esquivel@outlook.com
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Mexico
Clinical sites:
Not Applicable
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Recruiting
Date of first enrollment:
14/08/2020
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Prostate cancer
Health condition(s) code:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Prostatic Diseases
Genital Diseases, Male
Male Urogenital Diseases
Intervention(s):
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.
Intervention code:
Doxycycline
Leuprolide
Tablets
Placebos
Administration, Oral
Injections, Subcutaneous
Intervention keyword:
Bicalutamida
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Complete response (25% reduction in serum specific prostate antigen). Measuring time: 3 and 6 months.
Key secondary outcomes:
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.
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male
Minimum age:
18 years
Maximum age:
85 years
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.
Type of population:
Adults
Type of participant:
Patients
Study design
Section to complete information about the characteristics of the study design.
Type study:
Interventional
Purpose:
Treatment
Allocation:
Randomized controlled trial
Masking:
Double Blind
Control group:
Active
Study design:
Parallel
Phase:
2
Target sample size:
40
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
José
Last Name:
Guzman Esquivel
Specialty:
Urology
Affiliation:
Mexican Institute of Social Security, General Hospital of Zone 1
Postal Address:
Lapislazuli Avenue No 250, Colonia EL Haya
City:
Villa de Alvarez, Colima
Country:
Mexico
Zip Code:
28984
Telephone:
+52-312 316 3460
Email :
pepeguzman_esquivel@outlook.com
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
IVÁN
Last Name:
DELGADO ENCISO
Specialty:
MOLECULAR BIOLOGY
Affiliation:
Cancerology State Institute, Colima State Health Service
Postal Address:
Avenue Liceo de Varones 401, Colonia La Esperanza
City:
Colima
Country:
Mexico
Zip Code:
28085
Telephone:
+52-3121521435
Email :
ivancoliman@hotmail.com
ivan_delgado_enciso@ucol.mx
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
No
Research Ethics Committees
Section to complete the data related to the review ethics committees.
Name of Research Ethics Committees:
Comité de Ética local de Investigación en Salud del H. Gral Zona-MF-Num 1 (CONBIOETICA-06-CEI-001-2017121)
Status of evaluation:
Approved
Status of evaluation date of Ethic Committee:
20/08/2020
Postal address of Ethic Committee :
Av. Lapizlazulli No. 250, Colonia El Haya, Villa de Alvarez, Colima. Mexico
Telephone:
+52 312-316-3460
Email:
luis.deleon@imss.gob.mx
About study completion
Section to complete the data related to the study completion.
Final enrolment number:
32
Study completion date:
01/12/2021
Date of available results:
01/07/2022
Date of first publication:
01/12/2022
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000367
Date of Registration in Primary Registry:
11/05/2021
Record Verification Date:
2021/06/15
Next update date:
2022/06/15
Link to the spanish version:
Click here
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