Prostate CancerPSA-DEEP02NCT06652607
PSA Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer
An observational study of Prostate Cancer and Metastatic Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Metastatic Cancer, Castrate Sensitive Prostate Cancer
- What is being tested?
- Enzalutamide, Apalutamide (Erleada™) 60 mg or 240 mg tablets and Darolutamide (Nubeqa®) 300 mg tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 152 participants
- Where
- 1 siteItaly
- Study dates
- 20 Dec 2024to 30 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients without evidence of histological diagnosis of prostate cancer;
- No follow up visit after the beginning of therapy;
- No availability of baseline informations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC ONCOLOGIA MEDICA
Rome, Lazio, 00168
Roberto Iacovelli, +390630151, roberto.iacovelli@policlinicogemelli.it
Roberto Iacovelli
About this study
Official title: 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.
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.
Read more
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.
- Being tested
- Enzalutamide, Apalutamide (Erleada™) 60 mg or 240 mg tablets, Darolutamide (Nubeqa®) 300 mg tablets, Taxotere (docetaxel), Abiraterone acetate + Prednisone or Prednisolone
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzalutamideDrug
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 tabletsDrug
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 tabletsDrug
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 PrednisoloneDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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).
Measured: 4 years
To describe the baseline characteristics between patients with or without PSA response.
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).
Measured: 4 years
To describe the timing of PSA response
To describe the timing from the beginning of the ADT and the value ≤0.2 ng/dl among the responder patients.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start20 Dec 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberto Iacovelli, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652607
- Sponsor's protocol ID
- 7039
- Acronym
- PSA-DEEP02
- Status last verified
- Mar 2025
- First submitted
- 21 Oct 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06652607
- Acronym / sponsor ID
- PSA-DEEP02 / 7039
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (3 listed)
- Patients without evidence of histological diagnosis of prostate cancer;
- No follow up visit after the beginning of therapy;
- No availability of baseline informations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnzalutamideThe 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. | Drug | – |
| Apalutamide (Erleada™) 60 mg or 240 mg tabletsThe 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. | Drug | – |
| Darolutamide (Nubeqa®) 300 mg tabletsThe 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. | Drug | – |
| Taxotere (docetaxel)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. | Drug | – |
| Abiraterone acetate + Prednisone or PrednisoloneThe 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. | Drug | – |
Primary outcome
To evaluate the survival based on the PSA response at six months from the beginning of ARPI in patients with mCSPC.
Time frame: 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.
3 secondary outcomes
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.
Time frame: 4 years
To describe the baseline characteristics between patients with or without PSA response.
Time frame: 4 years
To describe the timing of PSA response
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roberto Iacovelli principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Metastatic Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Iacovelli (+390630157373, roberto.iacovelli@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the survival based on the PSA response at six months from the beginning of ARPI in patients with mCSPC. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.