NCT06652607 PSA Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer
| NCT ID | NCT06652607 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 152 participants |
| Start Date | 2024-12-20 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 152 participants in total. It began in 2024-12-20 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Prostate cancer remains the most common malignancy in men in Europe. Over the last two decades, the treatment landscape for both localized and metastatic prostate cancer has been revolutionized. For patients with metastatic castration-sensitive prostate cancer (mCSPC), the primary treatment objectives are to delay progression to metastatic castration-resistant prostate cancer (mCRPC) and to improve overall survival (OS). Although patients with PC may initially respond to androgen deprivation therapy (ADT), progression to castration resistance occurs in 10-20% of patients within 5 years. Primary ADT has been the standard of care for over 50 years. However, recent advancements have shifted treatment from ADT monotherapy for all mHSPC/mCRPC patients to more intensive approaches, which include combinations of ADT with new androgen receptor pathway inhibitors (ARPIs), chemotherapy, or both, tailored to tumor characteristics such as metastatic burden. In clinical practice, a reduction in prostatic specific antigen (PSA) levels from baseline is commonly used to monitor disease control, particularly in the castration sensitive phase (both early and metastatic). For patients with mCSPC, a decrease in PSA levels signifies that the treatment is effective. Moreover, the depth, time and duration of this PSA reduction are linked to better clinical outcomes, including OS. Although more patients achieved an optimal PSA response with intensified ADT (with ARPI or docetaxel), those with a suboptimal response have a significantly worse survival rate. Several key studies have demonstrated that achieving undetectable PSA (≤0.2 ng/mL) is associated with better OS, irrespective of subgroups. This study aims to evaluate patient survival based on PSA response and to describe baseline characteristics among patients with or without PSA response. Specifically, patients will be divided into two groups based on the achievement of PSA values ≤ 0.2 ng/dl, and overall survival (OS) and progression free survival (PFS) for each group will be evaluated. Clinical and laboratory information at baseline will be compared between the two groups. Baseline characteristics considered are histology, Gleason score, stage of disease, presence of genetic alterations, PSA values, sites and number of metastases, de novo or metachronous disease, high/low risk disease, high/low volume disease.
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.
Contact & Investigator
Roberto Iacovelli
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06652607 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06652607 currently recruiting?
Yes, NCT06652607 is actively recruiting participants. Contact the research team at roberto.iacovelli@policlinicogemelli.it for enrollment information.
Where is the NCT06652607 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06652607 clinical trial?
NCT06652607 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Roberto Iacovelli at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 152 participants.
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