FindTrial
Sign In

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

Evaluation of supraphysiological doses of Testosterone in patients with castration-resistant prostate Adenocarcinoma without metastases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8m3htgm
Enrollment
Unknown
Registered
2023-09-17
Start date
2023-09-28
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms, Castration-Resistant

Interventions

This clinical trial is a single-arm study with no control group. A total of 10 participants who meet the eligibility criteria will be allocated to the study. The patients will receive the administrat
D27.505.954.248.169

Sponsors

Universidade do Estado do Rio de Janeiro
Lead Sponsor
Universidade do Estado do Rio de Janeiro
Collaborator

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.; 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)—

Countries

Brazil

Contacts

Public ContactFabrício Carrerette

Universidade do Estado do Rio de Janeiro

carrerette2@gmail.com+5521 2868-8123

Outcome results

None listed

Source: REBEC (via WHO ICTRP)