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

NCT06652607 | Recruiting

• 1 other identifier: 7039
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Metastatic Cancer; Castrate Sensitive Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the survival based on the PSA response at six months from the beginning of ARPI in patients with mCSPC.

  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.

  4 years

Secondary Outcomes (3)

• 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 describe the baseline characteristics between patients with or without PSA response.

  4 years

• To describe the timing of PSA response

  4 years

Interventions

Enzalutamide DRUG

The objective of the study is to assess survival in patients treated with Enzalutamide according to PSA response and to describe the baseline characteristics of patients with and without an optimal PSA response.

Apalutamide (Erleada™) 60 mg or 240 mg tablets DRUG

The objective of the study is to assess survival in patients treated with Apalutamide according to PSA response and to describe the baseline characteristics of patients with and without an optimal PSA response.

Darolutamide (Nubeqa®) 300 mg tablets DRUG

The objective of the study is to assess survival in patients treated with Darolutamide according to PSA response and to describe the baseline characteristics of patients with and without an optimal PSA response.

Taxotere (docetaxel) DRUG

The objective of the study is to assess survival in patients treated with Taxotere according to PSA response and to describe the baseline characteristics of patients with and without an optimal PSA response.

Abiraterone acetate + Prednisone or Prednisolone DRUG

The objective of the study is to assess survival in patients treated with Abiraterone according to PSA response and to describe the baseline characteristics of patients with and without an optimal PSA response.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients affected by metastatic castration sensitive prostate cancer who received the diagnosis from July 2022 treaded, and started androgen deprivation therapy plus one ARPI-based therapy.

You may qualify if:

• 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.

You may not qualify if:

• Patients without evidence of histological diagnosis of prostate cancer;
• No follow up visit after the beginning of therapy;
• No availability of baseline informations.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC ONCOLOGIA MEDICA

Rome, Lazio, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

enzalutamide; apalutamide; darolutamide; Docetaxel; Abiraterone Acetate; Prednisone; Prednisolone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Pregnadienetriols

Study Officials

• Roberto Iacovelli

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Iacovelli

CONTACT

+390630157373; roberto.iacovelli@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 22, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): April 30, 2028
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

IT (1)