CIMAvax-EGF® in metastatic asymptomatic or mildly symptomatic Castration Resistant Prostate Cancer patients. Phase II-III Clinical Trial

Phase 2

• Conditions: Castration resistant prostate cancer; Prostatic Neoplasms, Castration-Resistant; Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Prostatic Diseases; Genital Diseases, Male; Male Urogenital Diseases

• Registration Number: RPCEC00000291
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients who have signed informed consent.
2. Patients who meet the diagnostic criterion of metastatic castration-resistant prostate adenocarcinoma (patient who after receiving surgical or biochemical castration (Testosterone < 50 ng/DL) progresses to a M1 stage corresponding to the IVb phase Of the disease according to the classification proposed by the AJCC in its eighth edition of the 2017 (any T, any N, M1, any grade group, any PSA).
3. Asymptomatic or minimally symptomatic patients. (Low pain levels measured by the Brief pain investigational Short Form Scale (BPI-SF) between 0-1 (asymptomatic) and 2-3 (minimally symptomatic) alleviated with acetaminophen or other non-steroidal anti-inflammatory drugs (CUA, 2015).
4. Patients with imaging study and clinical documentation to corroborate the existence of metastatic lesions prior to the onset of treatment for their metastatic disease, according to RECIST criteria (version 1.1).
5. Patients aged between 18 and 79 years.
6. Patients with life expectancy of 6 months or more.
7. Patients with functional status according to ECOG = 2.
8. Patients with organ and bone marrow functioning defined by the following parameters: Hemoglobin =90 g/L (patients with lower Hb levels should be transfused prior to inclusion), Total leukocyte Count = to 3.0 x 109/L, neutrophil count = 1.5 x 109/L, Platelet count=100 x 109/L, Bilirrubin: Within normal limits for each institution, Glycemia within normal limits for each institution, ALP: Up to 2.5 times the normal upper limit for each institution, GOT/GPT: up to 2.5 times the normal upper limit for each institution, Creatinine: Within normal limits for each institution.

Exclusion Criteria

1. Patients with cerebral metastases, history of primary CNS tumor, uncontrolled convulsions with standard therapy or history of brain vascular accident.
2. Patients with bone pain requiring treatment with opioids.
3. Patients with previous history of demyelinating or inflammatory diseases of the CNS or peripheral.
4. Patients with previous malignant diseases, except skin cancer (non-melanoma), properly treated.
5. Patients with acute allergic states, history of severe allergic reactions or autoimmune diseases.
6. Patients who are receiving another product in research.
7. Patients with a history of allergy attributed to compounds of chemical or biological composition similar to the product under study and/or the proposed Oncoespecífico treatment.
8. Patients carrying uncontrolled intercurrent illnesses, including, but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and psychiatric illnesses that may Limit adherence to test requirements.
9. Patients with symptoms at the time of diagnosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (Time from randomization until death from any cause). Measurement time: monthly for 3 years.