Prostate CancerNCT06154499
Archive Prostate. Observational Study of Patients Who Underwent 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 study on quality of life and disease status of patients who underwent radical prostatectomy. Data related to clinical conditions (oncological, psychological, sexual and quality of life) of these patients are collected in a database. 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?
- Radical prostatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,784 participants
- Where
- 1 siteItaly
- Study dates
- 8 Apr 2004to 13 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 with a diagnosis of prostate cancer who need to undergo radical prostatectomy surgery
Who may be able to join
- Patients with prostate cancer who underwent 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.
About this study
Official title: Archive Prostate. Observational Study of Patients Who Underwent Radical Prostatectomy Surgery. Long-term Evaluation of the Course of Prostate Cancer Associated With Quality of Life, Post-surgery Treatments and Occurrence of Any Disease Recurrence
This is a single-center, observational, prospective study on quality of life and disease status of patients who underwent radical prostatectomy. Data related to clinical conditions (oncological, psychological, sexual and quality of life) of these patients are collected in a database.
Read the detailed description
A database was created with the intention of collecting data related to patients with diagnosis of prostate cancer who underwent radical prostatectomy.
Anamnesis, surgery, histological report and hospitalization data are collected for patients who underwent radical prostatectomy.
Each patient will be followed for 10 years from the date of radical prostatectomy surgery.
Each patient will receive a questionnaire before radical prostatectomy in order to evaluate the quality of life (urinary continence, erectile function and psycho-physical wellbeing). A follow up questionnaire will be collected after surgery in order to analyze the predictive factors of the disease, clinical progression and to obtain health benefits for the patients involved and for future patients with the same tipe of cancer, improving the scientific knowledge of the pathology and implementing new strategies for diagnosis and therapy and evaluating the epidemiologic changes of prostate cancer. Tha data collected will be handles following the most strict Good Clinical Practice (GCPs) and privacy norms.
- Conditions
- Prostate Cancer
- Being tested
- 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.
Radical prostatectomyProcedure or surgery
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 referred to the Urology Department who need to undergo radical prostatectomy surgery | Not described Receives: Procedure: Radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Urinary continence recovery
Continence recovery evaluated with the International Consultation on Incontinence questionnaire - short form (ICIQ-SF), International Prostatic Symptoms Score (IPSS) questionnaires
Measured: 6 months after the intervention/procedure/surgery
Early Erectile function recovery
Erectile function recovery evaluated with the International Index of Erectile Function (IIEF) questionnaire
Measured: 6 months after the intervention/procedure/surgery
Prostate-specific antigen (PSA) persistence or biochemical recurrence
Serum PSA levels, conventional imaging
Measured: 6 months and every year after the intervention/procedure/surgery up to 10 years
Secondary outcomes (2)
Urinary continence recovery
Continence recovery evaluated with the International Consultation on Incontinence
Measured: every year after the intervention/procedure/surgery up to 10 years
Erectile function recovery
Erectile function recovery evaluated with the International Index of Erectile Function (IIEF)
Measured: every year after the intervention/procedure/surgery up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start8 Apr 2004
- Primary completion13 Feb 2025 (estimated)
- Study completion13 Feb 2025 (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
- Prospective
- Enrolment
- 1,784 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Montorsi, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154499
- Sponsor's protocol ID
- 2004- Prostata
- Status last verified
- Nov 2023
- First submitted
- 13 Oct 2023
- Last updated
- 4 Dec 2023
- 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 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Archive Prostate. Observational Study of Patients Who Underwent Radical Prostatectomy Surgery. Long-term Evaluation of the Course of Prostate Cancer Associated With Quality of Life, Post-surgery Treatments and Occurrence of Any Disease Recurrence
- ClinicalTrials.gov ID
- NCT06154499
- Acronym / sponsor ID
- 2004- Prostata
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,784 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 8 Apr 2004 (actual)
- Primary completion
- 13 Feb 2025 (estimated)
- Study completion
- 13 Feb 2025 (estimated)
- First posted
- 4 Dec 2023 (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 study on quality of life and disease status of patients who underwent radical prostatectomy. Data related to clinical conditions (oncological, psychological, sexual and quality of life) of these patients are collected in a database.
Detailed description
A database was created with the intention of collecting data related to patients with diagnosis of prostate cancer who underwent radical prostatectomy.
Anamnesis, surgery, histological report and hospitalization data are collected for patients who underwent radical prostatectomy.
Each patient will be followed for 10 years from the date of radical prostatectomy surgery.
Each patient will receive a questionnaire before radical prostatectomy in order to evaluate the quality of life (urinary continence, erectile function and psycho-physical wellbeing). A follow up questionnaire will be collected after surgery in order to analyze the predictive factors of the disease, clinical progression and to obtain health benefits for the patients involved and for future patients with the same tipe of cancer, improving the scientific knowledge of the pathology and implementing new strategies for diagnosis and therapy and evaluating the epidemiologic changes of prostate cancer. Tha data collected will be handles following the most strict Good Clinical Practice (GCPs) and privacy norms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referred to the Urology Department who need to undergo radical prostatectomy surgery | – | Procedure: 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 with a diagnosis of prostate cancer who need to undergo radical prostatectomy surgery
Key inclusion criteria (3 listed)
- Patients with prostate cancer who underwent 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 |
|---|---|---|
| Radical prostatectomyRadical Prostatectomy: surgery to remove the prostate gland and seminal vesicles (and sometimes nearby lymph nodes) after a prostate cancer diagnosis | Procedure or surgery | Patients referred to the Urology Department who need to undergo radical prostatectomy surgery |
Primary outcome
Early Urinary continence recovery
Time frame: 6 months after the intervention/procedure/surgery
Continence recovery evaluated with the International Consultation on Incontinence questionnaire - short form (ICIQ-SF), International Prostatic Symptoms Score (IPSS) questionnaires
Early Erectile function recovery
Time frame: 6 months after the intervention/procedure/surgery
Erectile function recovery evaluated with the International Index of Erectile Function (IIEF) questionnaire
Prostate-specific antigen (PSA) persistence or biochemical recurrence
Time frame: 6 months and every year after the intervention/procedure/surgery up to 10 years
Serum PSA levels, conventional imaging
2 secondary outcomes
Urinary continence recovery
Time frame: every year after the intervention/procedure/surgery up to 10 years
Erectile function recovery
Time frame: every year after the intervention/procedure/surgery up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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: status not confirmed, as of the sponsor's last update on 4 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Urinary continence recovery (time frame: 6 months after the intervention/procedure/surgery). The study lists 3 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 4 Dec 2023.