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

Recruiting

• Conditions: Prostate Cancer; Metastatic Cancer; Castrate Sensitive Prostate Cancer

• Registration Number: NCT06652607
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-21
• Study First Posted: 2024-10-22
• Study Start: 2024-12-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12
• Primary Completion: 2026-11-01
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 152

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the survival based on the PSA response at six months from the beginning of ARPI in patients with mCSPC.	4 years	To evaluate the overall survival (OS) between patients with or without a PSA response ≤0.2 ng/ml at six months (from the beginning of ADT) in patients with mCSPC.

Secondary Outcome Measures

Name	Time	Method
To evaluate the efficacy of ARPI-based therapy based on the PSA response at six months from the beginning of ARPI in patients with mCSPC.	4 years	To evaluate the progression-free survival (PFS) between patients with or without a PSA response ≤0.2 ng/ml at six months (from the beginning of ADT).
To describe the baseline characteristics between patients with or without PSA response.	4 years	To describe the baseline clinical and biological characteristics between patients who achieved a PSA response ≤0.2 ng/ml at six months (from the beginning of ADT).
To describe the timing of PSA response	4 years	To describe the timing from the beginning of the ADT and the value ≤0.2 ng/dl among the responder patients.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC ONCOLOGIA MEDICA; 🇮🇹 Roma, Lazio, Italy