Prostate CancerNCT06397755
Observational Study of Patients Who Underwent Diagnostic Investigation (Prostate Biopsy) and/or Radical Prostatectomy Surgery.
An observational study of Prostate Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This is a single-center, observational, prospective and retrospective study on quality of life and disease status of patients who underwent prostate biopsy and/or radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostate Biopsy and/or Radical Prostatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 20,000 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2015to 8 Jan 2065
- 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 admitted to the urology department who need undergo prostate biopsy and/or radical prostatectomy surgery
Who may be able to join
- Patients with a suspicious prostate disease who underwent prostate biopsy and/or radical prostatectomy;
- Adult patients > 18 years
- Ability to read and sign the informed consent
Who cannot join
- Patients < 18 years
- mental or physical disability that may prevent the patient from satisfying the requirements of the protocol
- Inability to read and sign the informed consent
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
IRCCS Ospedale San Raffaele
Milan
Andrea Salonia, +390226435661, salonia.andrea@hsr.it
Nadia Finocchio, +39 0226439425, finocchio.nadia@hsr.it
About this study
This is a single-center, observational, prospective and retrospective study on quality of life and disease status of patients who underwent prostate biopsy and/or radical prostatectomy.
Read the detailed description
A database was created with the intention of collecting data related to patients who underwent prostate biopsy and/or radical prostatectomy.
Only anamnesis and biopsy procedure data are collected for patients underwent prostate biopsy.
Anamnesis, surgery, histological report and hospitalization data are collected for patients who underwent radical prostatectomy.
Each patient will be followed for 50 years from the date of radical prostatectomy surgery.
Each patient will receive a questionnaire before radical prostatectomy. A follow up questionnaire will be collected after surgery relating to quality of life. The data for each patient will then be transferred to the database itself. The data collected will be handled following the most strict GCPs and privacy norms.
- Conditions
- Prostate Cancer
- Being tested
- Prostate Biopsy and/or Radical Prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate Biopsy and/or Radical ProstatectomyProcedure or surgery
Prostate Biopsy: procedure to remove samples of suspicious tissue from the prostate Radical Prostatectomy: surgery to remove the prostate gland and seminal vesicles (and sometimes nearby lymph nodes) after a prostate cancer diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Patients underwent prostate biopsy and/or radical prostatectomy surgery. | Not described Receives: Procedure: Prostate Biopsy and/or Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically significant Prostate Cancer
Diagnosis of clinically significant PCa at prostate biopsy
Measured: 1 month
Overall survival
Death by any cause
Measured: every 6 month after surgery up to 50 years after surgery
Cancer-specific mortality
Death from prostate cancer
Measured: every 6 month after surgery up to 50 years after surgery
Biochemical recurrence
PSA >= 0.2 ng/ml in 2 consecutive measures
Measured: every 6 month after surgery up to 50 years after surgery
Secondary outcomes (2)
Erectile function
IIEF-EF >=21
Measured: every 6 month after surgery up to 50 years after surgery
Urinary continence
No pads over a 24 hour period
Measured: every 6 month after surgery up to 50 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start8 Jan 2015
- Primary completion8 Jan 2065 (estimated)
- Study completion8 Jan 2065 (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.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Salonia, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397755
- Sponsor's protocol ID
- 2014-Prostata
- Status last verified
- Apr 2024
- First submitted
- 13 Oct 2023
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Patients Who Underwent Diagnostic Investigation (Prostate Biopsy) and/or Radical Prostatectomy Surgery.
- ClinicalTrials.gov ID
- NCT06397755
- Acronym / sponsor ID
- 2014-Prostata
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 8 Jan 2015 (actual)
- Primary completion
- 8 Jan 2065 (estimated)
- Study completion
- 8 Jan 2065 (estimated)
- First posted
- 3 May 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.
This is a single-center, observational, prospective and retrospective study on quality of life and disease status of patients who underwent prostate biopsy and/or radical prostatectomy.
Detailed description
A database was created with the intention of collecting data related to patients who underwent prostate biopsy and/or radical prostatectomy.
Only anamnesis and biopsy procedure data are collected for patients underwent prostate biopsy.
Anamnesis, surgery, histological report and hospitalization data are collected for patients who underwent radical prostatectomy.
Each patient will be followed for 50 years from the date of radical prostatectomy surgery.
Each patient will receive a questionnaire before radical prostatectomy. A follow up questionnaire will be collected after surgery relating to quality of life. The data for each patient will then be transferred to the database itself. The data collected will be handled following the most strict GCPs and privacy norms.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients underwent prostate biopsy and/or radical prostatectomy surgery. | – | Procedure: Prostate Biopsy and/or Radical Prostatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the urology department who need undergo prostate biopsy and/or radical prostatectomy surgery
Key inclusion criteria (3 listed)
- Patients with a suspicious prostate disease who underwent prostate biopsy and/or radical prostatectomy;
- Adult patients > 18 years
- Ability to read and sign the informed consent
Key exclusion criteria (3 listed)
- Patients < 18 years
- mental or physical disability that may prevent the patient from satisfying the requirements of the protocol
- Inability to read and sign the informed consent
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 |
|---|---|---|
| Prostate Biopsy and/or Radical ProstatectomyProstate Biopsy: procedure to remove samples of suspicious tissue from the prostate Radical Prostatectomy: surgery to remove the prostate gland and seminal vesicles (and sometimes nearby lymph nodes) after a prostate cancer diagnosis | Procedure or surgery | Patients underwent prostate biopsy and/or radical prostatectomy surgery. |
Primary outcome
Clinically significant Prostate Cancer
Time frame: 1 month
Diagnosis of clinically significant PCa at prostate biopsy
Overall survival
Time frame: every 6 month after surgery up to 50 years after surgery
Death by any cause
Cancer-specific mortality
Time frame: every 6 month after surgery up to 50 years after surgery
Death from prostate cancer
Biochemical recurrence
Time frame: every 6 month after surgery up to 50 years after surgery
PSA >= 0.2 ng/ml in 2 consecutive measures
2 secondary outcomes
Erectile function
Time frame: every 6 month after surgery up to 50 years after surgery
Urinary continence
Time frame: every 6 month after surgery up to 50 years after surgery
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 3 May 2024.
- Individual participant dataSharing planned: No
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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 IRCCS San Raffaele 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 3 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 3 May 2024. 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 Andrea Salonia (+39 0226435661, salonia.andrea@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically significant Prostate Cancer (time frame: 1 month). The study lists 4 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 3 May 2024.