PSA Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Oct 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well patients with metastatic castration-sensitive prostate cancer (mCSPC) respond to treatment, specifically looking at changes in prostate-specific antigen (PSA) levels. PSA is a substance made by the prostate that can indicate how well cancer is responding to therapy. The researchers want to understand how different levels of PSA reduction are linked to patient survival and overall health. By comparing patients who achieve very low PSA levels (0.2 ng/mL or lower) with those who do not, they aim to identify important factors that could help predict the effectiveness of treatment.

To participate in this trial, men aged 18 and older who have been diagnosed with metastatic prostate cancer and are currently being treated with specific medications called androgen receptor pathway inhibitors (ARPI) may be eligible. Participants will be monitored for their PSA levels at the start of treatment and after six months. The study will also collect various health information to understand how these factors might influence treatment outcomes. If you or a loved one is considering joining, it’s important to have a conversation with a healthcare provider to determine eligibility and understand what participation entails.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Aged ≥ 18 years old;
• • Men with histologically or cytologically confirmed adenocarcinoma of the prostate with evidence of metastases;
• • ECOG performance status ≤2;
• • Staging of disease with TC + bone scintigraphy or with PET PSMA/choline;
• • Availability of baseline PSA and after six months (±1) from the beginning of the ADT;
• • Ongoing or completed treatment with at least one ARPI among abiraterone acetate, apalutamide, darolutamide and enzalutamide;
• • Adequate information about baseline demographic, biological, clinical and laboratory data;
• • Signed informed consent form, or declaration in lieu of informed consent form, if applicable.
• Exclusion Criteria:
• • Patients without evidence of histological diagnosis of prostate cancer;
• • No follow up visit after the beginning of therapy;
• • No availability of baseline informations.