Evaluating PSA response in metastatic prostate cancer
Evaluation of Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer and Analysis of Baseline Characteristics Between Patients With or Without PSA Value of 0.2 ng/dl.
This study is testing how changes in PSA levels can help doctors understand how well treatments are working for men with advanced prostate cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 152 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rome, Lazio) |
| Trial ID | NCT06652607 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older with confirmed metastatic castration-sensitive prostate cancer who are undergoing treatment with androgen receptor pathway inhibitors.
Not a fit: Patients without a confirmed diagnosis of prostate cancer or those who do not have follow-up visits after starting therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies and outcomes for patients with metastatic prostate cancer.
How similar studies have performed: Other studies have shown promising results in using PSA levels as a prognostic factor in prostate cancer, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rome, Lazio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.