Prostate CancerNCT06200558
ARON-3 Study: International Multicentric Retrospective Study to Collect Global Experiences in the Treatment of Patients With Metastatic PCa
An observational study of Prostate Cancer, run by Hospital of Macerata at 1 site in Italy.
Trial summary
Study wants to explore real-world data in three distinct settings Patients with metachronous or de novo mCSPC treated with ADT+ARSI or ADT+ARSI+docetaxel _ARON-3S Patients receiving Lutetium-177 PSMA for mCRPC _ ARON-3Lu Patients treated with PARP inhibitors (alone or combined with ARSI) for CRPC _ ARON-3GEN Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer
- How many people
- 534 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jan 2024to 1 Feb 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: treatment of patients with metastatic PCa. In the ARON-3 Study the investigators focused on three different settings: * ARON-3S: Patients with metachronous or de novo metastatic hormone/castration-sensitive PCa treated with ADT + ARSI or ADT + ARSI + docetaxel * ARON-3Lu: Patients receiving Lutetium-177 PSMA for castration resistant PC (CRPC) * ARON-3GEN: Patients treated with PARP inhibitors (alone or plus ARSI) for CRPC
Who may be able to join
- Patients aged >18y
- Cytological or Histologically confirmed diagnosis of PC
- Histologically or radiologically confirmed diagnosis of metastatic disease and
- For ARON-3S
- Treatment with ADT + Apalutamide or ADT + enzalutamide or ADT + Abiraterone or ADT + Abiraterone + Docetaxel or ADT + Darolutamide + Docetaxel (patients treated with previous docetaxel - CHAARTED - resulted eligible)
- For ARON-3Lu
Show all 10Show fewer
- Treatment with Luthetium-177-PSMA therapy for castration resistant PC
- For ARON-3GEN
- HRD POSITIVE STATUS
- Treatment with PARP inhibitors for castration resistant PC. Treatment included: olaparib (as 1st, 2nd or 3rd line therapy), olaparib + abiraterone (as 1st line therapy) or niraparib + abiraterone (as 1st line therapy) or talazoparib + enzalutamide
Who cannot join
- Patients without histologically confirmed diagnosis of PC
- Patients without histologically or radiologically confirmed metastatic disease and
- For ARON-3S
- Patients treated with doublets or triplets not included in the list reported in the Inclusion Criteria Section
- For ARON-3Lu
- Patients treated with Luthetium-177-PSMA therapy for hormone/castration sensitive PC
Show all 9Show fewer
- For ARON-3GEN
- HRD NEGATIVE STATUS
- Patients treated with PARP inhibitors alone or in combination regimens not included in the ARON-3GEN study
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
Ospedale di Macerata
Province of Macerata, Macerata, 62100
Matteo Santoni, MD, PhD, +3907332573752, sorgentoni.giulia@gmail.com
About this study
Study wants to explore real-world data in three distinct settings
- Patients with metachronous or de novo mCSPC treated with ADT+ARSI or ADT+ARSI+docetaxel _ARON-3S
- Patients receiving Lutetium-177 PSMA for mCRPC _ ARON-3Lu
- Patients treated with PARP inhibitors (alone or combined with ARSI) for CRPC _ ARON-3GEN
- Conditions
- Prostate Cancer
- Keywords
- mCSPC, Lutetium-177 PSMA, PARP inhibitors, ADT, ARSI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| For ARON-3S: Patients with metachronous or de novo metastatic hormone/castration-sensitive PCa | Patients with metachronous or de novo metastatic hormone/castration-sensitive PCa treated with ADT+ARSI or ADT+ARSI+docetaxel | |
| For ARON-3Lu: Patients receiving Lutetium-177 PSMA for castration resistant PC (CRPC) | Not described | |
| For ARON-3GEN: Patients treated with PARP inhibitors (alone or plus ARSI) for CRPC | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel
Measured: January 31h, 2024- May 31th, 2024
Progression-Free Survival of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel
Measured: January 31h, 2024- May 31th, 2024
Overall Response Rate of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel
Measured: January 31h, 2024- May 31th, 2024
Overall Survival (OS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy
Measured: January 31h, 2024- May 31th, 2024
Progression-Free Survival (PFS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy
Measured: January 31h, 2024- May 31th, 2024
Overall Response Rate (ORR) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy
Measured: January 31h, 2024- May 31th, 2024
Overall Survival (OS) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens
Measured: January 31h, 2024- May 31th, 2024
Progression-Free Survival (PFS) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens
Measured: January 31h, 2024- May 31th, 2024
Overall Response Rate (ORR) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens
Measured: January 31h, 2024- May 31th, 2024
Secondary outcomes (2)
Time to progression of patients with different metastatic sites treated by the distinct combinations
Statistical analysis of data obtained by medical charts related to disease metastatic sites, treatment performed and period of time from the start of treatment until the radiological progression disease
Measured: January 31h, 2024- May 31th, 2024
prognostic role of lifestyle and concomitant medications
Statistical analysis of data obtained by medical charts related to lifestyle and concomitant medications
Measured: January 31h, 2024- May 31th, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start31 Jan 2024
- Primary completion31 May 2024
- Study completion1 Feb 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 534 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital of Macerata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Santoni, Hospital of Macerata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200558
- Sponsor's protocol ID
- ARON-3
- Status last verified
- Nov 2025
- First submitted
- 3 Dec 2023
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARON-3 Study: International Multicentric Retrospective Study to Collect Global Experiences in the Treatment of Patients With Metastatic PCa
- ClinicalTrials.gov ID
- NCT06200558
- Acronym / sponsor ID
- ARON-3
- Conditions
- Prostate Cancer
- Keywords
- mCSPC, Lutetium-177 PSMA, PARP inhibitors, ADT, ARSI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 534 participants (estimated)
- Lead sponsor
- Hospital of MacerataUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 11 Jan 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.
Study wants to explore real-world data in three distinct settings
- Patients with metachronous or de novo mCSPC treated with ADT+ARSI or ADT+ARSI+docetaxel _ARON-3S
- Patients receiving Lutetium-177 PSMA for mCRPC _ ARON-3Lu
- Patients treated with PARP inhibitors (alone or combined with ARSI) for CRPC _ ARON-3GEN
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| For ARON-3S: Patients with metachronous or de novo metastatic hormone/castration-sensitive PCa | – | –Patients with metachronous or de novo metastatic hormone/castration-sensitive PCa treated with ADT+ARSI or ADT+ARSI+docetaxel |
| For ARON-3Lu: Patients receiving Lutetium-177 PSMA for castration resistant PC (CRPC) | – | – |
| For ARON-3GEN: Patients treated with PARP inhibitors (alone or plus ARSI) for CRPC | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- treatment of patients with metastatic PCa. In the ARON-3 Study the investigators focused on three different settings: * ARON-3S: Patients with metachronous or de novo metastatic hormone/castration-sensitive PCa treated with ADT + ARSI or ADT + ARSI + docetaxel * ARON-3Lu: Patients receiving Lutetium-177 PSMA for castration resistant PC (CRPC) * ARON-3GEN: Patients treated with PARP inhibitors (alone or plus ARSI) for CRPC
Key inclusion criteria (10 listed)
- Patients aged >18y
- Cytological or Histologically confirmed diagnosis of PC
- Histologically or radiologically confirmed diagnosis of metastatic disease and
- For ARON-3S
- Treatment with ADT + Apalutamide or ADT + enzalutamide or ADT + Abiraterone or ADT + Abiraterone + Docetaxel or ADT + Darolutamide + Docetaxel (patients treated with previous docetaxel - CHAARTED - resulted eligible)
Key exclusion criteria (9 listed)
- Patients without histologically confirmed diagnosis of PC
- Patients without histologically or radiologically confirmed metastatic disease and
- For ARON-3S
- Patients treated with doublets or triplets not included in the list reported in the Inclusion Criteria Section
- For ARON-3Lu
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival (OS) of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel
Time frame: January 31h, 2024- May 31th, 2024
Progression-Free Survival of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel
Time frame: January 31h, 2024- May 31th, 2024
Overall Response Rate of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel
Time frame: January 31h, 2024- May 31th, 2024
Overall Survival (OS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy
Time frame: January 31h, 2024- May 31th, 2024
Progression-Free Survival (PFS) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy
Time frame: January 31h, 2024- May 31th, 2024
Overall Response Rate (ORR) of patients with castration resistant PC treated with Luthetium-177-PSMA therapy
Time frame: January 31h, 2024- May 31th, 2024
Overall Survival (OS) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens
Time frame: January 31h, 2024- May 31th, 2024
Progression-Free Survival (PFS) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens
Time frame: January 31h, 2024- May 31th, 2024
Overall Response Rate (ORR) of patients with castration resistant PC treated with PARP inhibitors alone or in combined regimens
Time frame: January 31h, 2024- May 31th, 2024
2 secondary outcomes
Time to progression of patients with different metastatic sites treated by the distinct combinations
Time frame: January 31h, 2024- May 31th, 2024
prognostic role of lifestyle and concomitant medications
Time frame: January 31h, 2024- May 31th, 2024
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 26 Nov 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.
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, run by Hospital of Macerata 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 10 inclusion and 9 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 26 Nov 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 Matteo Santoni (+39 07332573752, sorgentoni.giulia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) of patients with hormone/castration-sensitive PC treated with ADT + ARSI or ADT + ARSI + docetaxel (time frame: January 31h, 2024- May 31th, 2024). The study lists 9 primary outcomes in all. 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 26 Nov 2025.