Evaluation of the Activity of Supraphysiological Testosterone Doses in the Fall of PSA in Patients with Prostate Cancer Unresponsive to the lack of Testosterone and without Metastases
Not Applicable
- Conditions
- Prostatic Neoplasms, Castration-Resistant
- Registration Number
- RBR-8m3htgm
- Lead Sponsor
- niversidade do Estado do Rio de Janeiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
Patients between 18 and 75 years old; diagnosis of prostate adenocarcinoma without neuroendocrine differentiation or unconventional subtypes; resistant to surgical or medical castration; not metastatic; PSA doubling time < 10 months
Exclusion Criteria
Patients with PS > 2; Presence of moderate to severe organic dysfunctions related, among others, to liver, kidney or heart function; Uncontrolled primary prostatic disease; Presence of previous or current diagnosis of another neoplasm except non-melanoma skin cancer; Positive pelvic node disease, considered as any pelvic lymph node larger than 2.0 cm in the shortest axis
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the Prostate Specific Antigen 50 Response Rate (PSA50 > 50% Reduction on inicial PSA value) after administration of 3 supraphysiological doses of Testosterone plus androgen deprivation therapy in patients with non-metastatic castration-resistant prostate cancer and prostate specific antigen doubling time < 10 months.
- Secondary Outcome Measures
Name Time Method We expect that half of the population will have presented metastases up to 18 months in the absence of intervention in this population, according to data from 3 randomized studies. We aimed to evaluate, through conventional imaging exams (Chest X-ray or Chest CT, CT or MRI of the abdomen and pelvis and bone scintigraphy) the percentage of patients without metastases in 18 months, reporting metastasis-free survival in 18 months in the study.;<br>We expect to find a partial drop in prostate-specific antigen in a portion of the population that does not obtain prostate-specific antigen 50, verified by the decrease in serum prostate-specific antigen between 10 and 49% compared to its initial value before the intervention (three administrations of testosterone)<br>