Prostatic NeoplasmSTARTNCT03348722
Active Surveillance or Radical Treatment for Newly Diagnosed Patients With a Localized, Low Risk, Prostate Cancer START
An observational study of Prostatic Neoplasm, run by Rete Oncologica Piemonte, Valle d'Aosta at 1 site in Italy.
Trial summary
The purpose of the START project is to evaluate the acceptability, the safety and the cost-effectiveness of a population based program of active surveillance for patients newly diagnosed with a localized, low risk, prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasm
- What is being tested?
- Active surveillance, Radical prostatectomy and Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 850 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2015to 1 Mar 2023
- 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: Newly diagnosed low risk prostate cancer patients resident in Piemonte or in Valle D'Aosta regions (Northern Italy)
Who may be able to join
None listed.
Who cannot join
- Patients previously treated for prostate cancer.
- Patients not willing to undergo radical treatments (surgery or radiotherapy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: START (Active Surveillance or Radical Treatment for Newly Diagnosed Patients With a Localized, Low Risk, Prostate Cancer): an Epidemiological Study of the Oncology Network of Piemonte and Valle d'Aosta (Italy)
The purpose of the START project is to evaluate the acceptability, the safety and the cost-effectiveness of a population based program of active surveillance for patients newly diagnosed with a localized, low risk, prostate cancer.
Read the detailed description
Comparative effectiveness research project. All newly diagnosed prostate cancer patients fulfilling the low risk definition, resident in Piedmont or in Valle D'Aosta regions, will be invited to participate. All enrolled patients will receive full and clear information about their prognosis together with a balanced synthesis of the benefits and risks of the available treatments (active surveillance or radical treatments).
Specific objectives are:
- To estimate, at a population level, the proportion of newly diagnosed prostate cancer at low risk, eligible for active surveillance, the proportion of those accepting to be enrolled in a cohort of active surveillance and the risk of abandoning the program during follow-up.
- To compare the patients' and physicians' characteristics of those accepting to be managed within the active surveillance program with those preferring a radical treatment (either surgery or radiotherapy).
- To compare, at a population level, the clinical outcomes, quality of life and costs associated to different treatment choices.
- Conditions
- Prostatic Neoplasm
- Being tested
- Active surveillance, Radical prostatectomy, Radiotherapy, Other radical treatments
- Keywords
- Active surveillance, Low risk prostate cancer, Prostatic neoplasm/therapy (MESH), Prostatic neoplasm/surgery (MESH), Prostatic neoplasm/radiotherapy (MESH), Prostatectomy (MESH), Quality of life (MESH), Costs and Cost Analysis (MESH)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active surveillanceOther
PSA testing (every 3 months, then every 6 after 30 months), clinical visit and DRE every 6 months, prostate biopsy after 1, 4 and 7 years
Radical prostatectomyProcedure or surgery
Radical prostatectomy (open, laparoscopic or robotic)
RadiotherapyRadiation
External radical radiotherapy or brachitherapy
Other radical treatmentsProcedure or surgery
High intensity focal ultrasound, cryotherapy, others
| Study group | Role | What they receive |
|---|---|---|
| Active surveillance | Newly diagnosed low risk prostate cancer patients managed according to an active surveillance program Receives: Other: Active surveillance | |
| Radical prostatectomy | Newly diagnosed low risk prostate cancer patients undergoing radical prostatectomy Receives: Procedure: Radical prostatectomy | |
| Radiotherapy | Newly diagnosed low risk prostate cancer patients undergoing radiotherapy (external or brachitherapy) Receives: Radiation: Radiotherapy | |
| Other radical treatment | Newly diagnosed low risk prostate cancer patients undergoing other radical treatments (HIFU, cryotherapy, others) Receives: Procedure: Other radical treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Free Survival (TFS)
Proportion of patients in active surveillance program alive and not undergoing active treatment for prostate cancer.
Measured: Up to 24 months
Secondary outcomes (8)
Quality of Life
Measured through validated questionnaire EORTC QLQ-C30 at baseline and every six months during the first 2 years.
Measured: Up to 24 months
Quality of Life
Measured through validated questionnaire QLQ-PR25 at baseline and every six months during the first 2 years.
Measured: Up to 24 months
Quality of Life
Measured through validated questionnaire IPSS at baseline and every six months during the first 2 years.
Measured: Up to 24 months
Quality of Life
Measured through validated questionnaire IIEF-5 at baseline and every six months during the first 2 years.
Measured: Up to 24 months
Quality of Life
Measured through validated questionnaire HADS at baseline and every six months during the first 2 years.
Measured: Up to 24 months
Quality of Life
Measured through validated questionnaire EuroQol-5D at baseline and every six months during the first 2 years.
Measured: Up to 24 months
Quality of Life
Measured through validated questionnaire MHLC -Form C at baseline and every six months during the first 2 years.
Measured: Up to 24 months
Cost-effectiveness
Incremental cost-effectiveness ratio calculated as the ratio between difference in costs and difference in QALYs (Quality Adjusted Life Years, from EQ-5D) among the treatment groups, during the first 2 years after diagnosis
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start15 May 2015
- Primary completion31 Dec 2021
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmStudies 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
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rete Oncologica Piemonte, Valle d'Aosta
- Sponsor type
- University, hospital or other
- Collaborators
- Compagnia di San Paolo, A.O.U. Città della Salute e della Scienza
- Responsible party
- Sponsor
- Investigators
- Oscar Bertetto, MD, Principal investigator, Oncology Network of Piedmont and Valle d'Aosta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348722
- Sponsor's protocol ID
- START
- Acronym
- START
- Status last verified
- Mar 2023
- First submitted
- 19 Jun 2017
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- START (Active Surveillance or Radical Treatment for Newly Diagnosed Patients With a Localized, Low Risk, Prostate Cancer): an Epidemiological Study of the Oncology Network of Piemonte and Valle d'Aosta (Italy)
- ClinicalTrials.gov ID
- NCT03348722
- Acronym / sponsor ID
- START / START
- Conditions
- Prostatic Neoplasm
- Keywords
- Active surveillance, Low risk prostate cancer, Prostatic neoplasm/therapy (MESH), Prostatic neoplasm/surgery (MESH), Prostatic neoplasm/radiotherapy (MESH), Prostatectomy (MESH), Quality of life (MESH), Costs and Cost Analysis (MESH)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- Rete Oncologica Piemonte, Valle d'AostaUniversity, hospital or other
- Collaborators
- Compagnia di San Paolo, A.O.U. Città della Salute e della Scienza
- Study start
- 15 May 2015 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 21 Nov 2017 (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.
The purpose of the START project is to evaluate the acceptability, the safety and the cost-effectiveness of a population based program of active surveillance for patients newly diagnosed with a localized, low risk, prostate cancer.
Detailed description
Comparative effectiveness research project. All newly diagnosed prostate cancer patients fulfilling the low risk definition, resident in Piedmont or in Valle D'Aosta regions, will be invited to participate. All enrolled patients will receive full and clear information about their prognosis together with a balanced synthesis of the benefits and risks of the available treatments (active surveillance or radical treatments).
Specific objectives are:
- To estimate, at a population level, the proportion of newly diagnosed prostate cancer at low risk, eligible for active surveillance, the proportion of those accepting to be enrolled in a cohort of active surveillance and the risk of abandoning the program during follow-up.
- To compare the patients' and physicians' characteristics of those accepting to be managed within the active surveillance program with those preferring a radical treatment (either surgery or radiotherapy).
- To compare, at a population level, the clinical outcomes, quality of life and costs associated to different treatment choices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active surveillance | – | Other: Active surveillanceNewly diagnosed low risk prostate cancer patients managed according to an active surveillance program |
| Radical prostatectomy | – | Procedure: Radical prostatectomyNewly diagnosed low risk prostate cancer patients undergoing radical prostatectomy |
| Radiotherapy | – | Radiation: RadiotherapyNewly diagnosed low risk prostate cancer patients undergoing radiotherapy (external or brachitherapy) |
| Other radical treatment | – | Procedure: Other radical treatmentsNewly diagnosed low risk prostate cancer patients undergoing other radical treatments (HIFU, cryotherapy, others) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed low risk prostate cancer patients resident in Piemonte or in Valle D'Aosta regions (Northern Italy)
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Patients previously treated for prostate cancer.
- Patients not willing to undergo radical treatments (surgery or radiotherapy).
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 |
|---|---|---|
| Active surveillancePSA testing (every 3 months, then every 6 after 30 months), clinical visit and DRE every 6 months, prostate biopsy after 1, 4 and 7 years | Other | Active surveillance |
| Radical prostatectomyRadical prostatectomy (open, laparoscopic or robotic) | Procedure or surgery | Radical prostatectomy |
| RadiotherapyExternal radical radiotherapy or brachitherapy | Radiation | Radiotherapy |
| Other radical treatmentsHigh intensity focal ultrasound, cryotherapy, others | Procedure or surgery | Other radical treatment |
Primary outcome
Treatment-Free Survival (TFS)
Time frame: Up to 24 months
Proportion of patients in active surveillance program alive and not undergoing active treatment for prostate cancer.
8 secondary outcomes
Quality of Life
Time frame: Up to 24 months
Quality of Life
Time frame: Up to 24 months
Quality of Life
Time frame: Up to 24 months
Quality of Life
Time frame: Up to 24 months
Quality of Life
Time frame: Up to 24 months
Quality of Life
Time frame: Up to 24 months
Quality of Life
Time frame: Up to 24 months
Cost-effectiveness
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- https://start.epiclin.it/homeLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Oscar Bertetto, MD principal investigator
Oncology Network of Piedmont and Valle d'Aosta
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 Prostatic Neoplasm, run by Rete Oncologica Piemonte, Valle d'Aosta 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 0 inclusion and 2 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: finished, as of the sponsor's last update on 31 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment-Free Survival (TFS) (time frame: Up to 24 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 31 Mar 2023.