Heberprovac Study

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.

Scientific title:

Employment GnRHm1-TT in the treatment of patients with prostate adenocarcinoma.

Secondary indentifying numbers:

IG/GnRHI/CP/0501

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB).

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB), Havana. Ministry of Public Health, CUBA.

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:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

09/01/2007

Reference number:

073/05037.0513

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Ranfis Rodríguez Bueno, MD.1st Degree Specialist in Urology

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

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:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

Provincial Oncology Hospital "Marie Curie", January 8, 2005.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

08/03/2007

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 Adenocarcinoma

Intervention(s):

Intramuscular injection of 7 doses of the synthetic peptide GnRHm1-TT final volume of 0.7 mL (3 mg), using 7 consecutive injection sites in the following order: left deltoid, right deltoid, left buttock, right buttock, region left femoral, right femoral region and left buttock again. The application frequency was every 15 days for the first 4 injections, and monthly for the remaining 3.

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):

Reactogenicity (frequency and type of adverse events amount, number of patients with adverse events). Measurement time: within 48 hours and inter-immunization periods until the end of treatment.

Key secondary outcomes:

- Immunogenicity of GnRHm1-TT vaccine (Gen titles Rh Antibodies m1TT). Measurement time: After the 4th immunization and after the treatment. - Levels of castration (testosterone levels by RIA, serum PSA). Measurement time: After the 4th immunization and after the treatment. - tumor response assessed by computed tomography, ultrasound and / or bone study (tumor diameter). Measurement time: After the 4th immunization and after the 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) Histological diagnosis of prostate cancer classified by TNM stage III / IV. 2) Presence of residual lesion after the initial punch with a diameter = 10 mm (measured by ultrasonography, scintigraphy and CT) 3) Age between 18 and 85 years inclusive. 4) Written consent from the patient 5) Clinical laboratory parameters within normal limits 6) Overall index from 0 to 2 according to the WHO classification. 7) Life expectancy = 1 year.

Exclusion criteria:

1) anti-GnRH response demonstrated by ELISA. 2) Referred immunodeficiency states. 3) Having undergone surgery, ablative, radiant, immunomodulatory or chemotherapy, up to 3 months prior to inclusion. 4) Excision of target organs (pituitary, adrenals, testes, prostate). 5) Moderate or severe systemic infections that interfere with patient evaluation. 6) History of decompensated chronic diseases (WHO grade = 2). 7) Diseases that compromise the patient's consciousness or the ability to collaborate in the trial. 8) Any type of malignancy, in addition to the study, except basal cell skin carcinoma. 9) Be included in another trial. 10) Hypersensitivity to similar products and adjuvants.

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:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

Target sample size:

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:

Dr. Lidia

Last Name:

González Méndez

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

lidia.gonzalez@cigb.edu.cu [2]

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:

Dr. Lidia

Last Name:

González Méndez

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

lidia.gonzalez@cigb.edu.cu [2]

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:

RPCEC00000111

Date of Registration in Primary Registry:

2011-05-16

Record Verification Date:

2011-04-27 20:00

Link to the spanish version:

Click here [3]