Prostate CancerCOROSNCT06783127
Clinical Outcomes of Use of Olaparib in Castration Resistant Prostate Cancer
An observational study of Prostate Cancer and Castrate Resistant Prostate Cancer, run by Santa Chiara Hospital at 2 sites in Italy.
Trial summary
This is an observational, retrospective/prospective, multicenter study designed to define, overall survival, clinical outcomes and predictive/prognostic factors of a consecutive population of mCRPC patients treated with olaparib in clinical practice. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Castrate Resistant Prostate Cancer, BRCA Mutation
- What is being tested?
- Olaparib
- How many people
- 3,000 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jan 2023to 31 Dec 2026
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: BRCA mutant Metastatic castration-resistant prostate cancer patients progressing after first-line ARPI who are treated with olaparib in clinical practice
Who may be able to join
- BRCA mutant Metastatic castration-resistant prostate cancer patients treatment with olaparib in clinical practice
Who cannot join
- Olaparib treatment in a clinical trial
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Sabrina Rossetti
Naples
Sabrina Rossetti
- Recruiting
Orazio Caffo
Trento
Orazio Caffo
About this study
Official title: Clinical Outcomes of Use of Olaparib in Castration Resistant Prostate Cancer: An Observational Study
This is an observational, retrospective/prospective, multicenter study designed to define, overall survival, clinical outcomes and predictive/prognostic factors of a consecutive population of mCRPC patients treated with olaparib in clinical practice.
- Being tested
- Olaparib
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaparibDrug
Olaparib given according the clinical practice to BRCA positive mCRPC patients
| Study group | Role | What they receive |
|---|---|---|
| mCRPC treated with olaparib | mCRPC patients who receive olaparib in daily clinical practice Receives: Drug: Olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease control
projected survival from treatment start
Measured: From the date of treatment start until the date of last follow-up or date of death from any cause, whichever came first, assessed up to 120 months
Secondary outcomes (4)
biochemical response
rate of patients with PSA reduction > 50%
Measured: Through study completion, an average of 1 years
response rate
rate of patients with measurable disease showing partial or complete response
Measured: Through study completion, an average of 1 years
PFS
projected survival without progression
Measured: From the date of treatment start until the date of first progression or date of death from any cause, whichever came first, assessed up to 120 months
toxicity rate
toxicity recorded during the treatment
Measured: Through study completion, an average of 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santa Chiara Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orazio Caffo, Santa Chiara Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783127
- Sponsor's protocol ID
- A809
- Acronym
- COROS
- Status last verified
- Feb 2025
- First submitted
- 14 Jan 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Use of Olaparib in Castration Resistant Prostate Cancer: An Observational Study
- ClinicalTrials.gov ID
- NCT06783127
- Acronym / sponsor ID
- COROS / A809
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Santa Chiara HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jan 2025 (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.
This is an observational, retrospective/prospective, multicenter study designed to define, overall survival, clinical outcomes and predictive/prognostic factors of a consecutive population of mCRPC patients treated with olaparib in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mCRPC treated with olaparib | – | Drug: OlaparibmCRPC patients who receive olaparib in daily clinical practice |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- BRCA mutant Metastatic castration-resistant prostate cancer patients progressing after first-line ARPI who are treated with olaparib in clinical practice
Key inclusion criteria (1 listed)
- BRCA mutant Metastatic castration-resistant prostate cancer patients treatment with olaparib in clinical practice
Key exclusion criteria (1 listed)
- Olaparib treatment in a clinical trial
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 |
|---|---|---|
| OlaparibOlaparib given according the clinical practice to BRCA positive mCRPC patients | Drug | mCRPC treated with olaparib |
Primary outcome
disease control
Time frame: From the date of treatment start until the date of last follow-up or date of death from any cause, whichever came first, assessed up to 120 months
projected survival from treatment start
4 secondary outcomes
biochemical response
Time frame: Through study completion, an average of 1 years
response rate
Time frame: Through study completion, an average of 1 years
PFS
Time frame: From the date of treatment start until the date of first progression or date of death from any cause, whichever came first, assessed up to 120 months
toxicity rate
Time frame: Through study completion, an average of 1 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 11 Feb 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.
2 sites 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 Castrate Resistant Prostate Cancer, run by Santa Chiara Hospital at 2 sites 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 1 inclusion and 1 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 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Orazio Caffo, MD (+390461902478, orazio.caffo@apss.tn.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease control (time frame: From the date of treatment start until the date of last follow-up or date of death from any cause, whichever came first, assessed up to 120 months). 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 11 Feb 2025.