Evaluating PSA response in metastatic prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the biochemical response of prostate-specific antigen (PSA) levels as a prognostic factor in men with metastatic castration-sensitive prostate cancer (mCSPC). It focuses on patients undergoing androgen deprivation therapy (ADT) and other treatments, including new androgen receptor pathway inhibitors and chemotherapy. The study will collect baseline and follow-up PSA data to evaluate treatment effectiveness and progression to castration-resistant prostate cancer. The findings could help tailor future treatment strategies based on individual patient responses.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC ONCOLOGIA MEDICA
  Rome, Lazio, Italy Recruiting

Study contacts

• Principal investigator: Roberto Iacovelli — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Roberto Iacovelli
• Email: roberto.iacovelli@policlinicogemelli.it
• Phone: +390630157373

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.