Prostate Adenocarcinoma
Conditions
Interventions
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 butto
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), Camagüey.
Center for Genetic Engineering and Biotechnology (CIGB), Havana. Ministry of Public Health, CUBA.
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| - 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. | — |
Countries
Cuba
Contacts
Public ContactDr. Lidia González Méndez
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed