Heberprovac Study

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000111
• Date of registration: 16/05/2011
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB), Camagüey.
• Public title: Heberprovac Study
• Scientific title: Employment GnRHm1-TT in the treatment of patients with prostate adenocarcinoma.
• Date of first enrolment: 08/03/2007
• Target sample size: 8
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000111-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Dr. Lidia González Méndez
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

• Name: Dr. Lidia González Méndez
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: 85 years
Gender: Male

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.

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.

Secondary Outcome(s)

- 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.

Secondary ID(s)

IG/GnRHI/CP/0501

Source(s) of Monetary Support

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

Secondary Sponsor(s)

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