Active Surveillance or Radical Treatment for Newly Diagnosed Patients With a Localized, Low Risk, Prostate Cancer START

Prostatic Neoplasm Clinical Trial

— START  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03348722
• Other study ID #: START
• Status: Completed
• Start date: May 15, 2015
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2023
• Source: Rete Oncologica Piemonte, Valle d'Aosta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 850
• Est. completion date: March 1, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

IInclusion Criteria:

1. Newly diagnosed low risk prostate cancer patients, defined according to the presence

of all the following criteria:

• diagnosis of adenocarcinoma of the prostate
• prostate cancer clinical stage T1c o T2a
• PSA <=10ng/ml at diagnosis
• adequate biopsy sampling according to prostate volume
• maximum of two positive cores for random sampling and of maximum two lesions for target biopsies (even if the number of positive samples if >2)
• Gleason grade 3+3 ( in patients age>70 Gleason 3+4)

2. Residence in Piemonte or Valle D'Aosta regions;

3. Patients suitable for radical treatment (surgery or radiotherapy);

4. Age at diagnosis <= 75 years or >75 years if fragility assessment (measured with the G8 score)> = 14;

5. Patients suitability for expressing a valid consent to participate in the study.

Exclusion Criteria:

1. Patients previously treated for prostate cancer.

2. Patients not willing to undergo radical treatments (surgery or radiotherapy).

Related Conditions & MeSH terms

• Neoplasms
• Prostatic Neoplasm
• Prostatic Neoplasms

Intervention

Other:
• Active surveillance
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

Procedure:
• Radical prostatectomy
Radical prostatectomy (open, laparoscopic or robotic)

Radiation:
• Radiotherapy
External radical radiotherapy or brachitherapy

Procedure:
• Other radical treatments
High intensity focal ultrasound, cryotherapy, others

Locations

Country	Name	City	State
Italy	Oncolgy Network of Piemonte and Valle d'Aosta - Turin	Turin

Sponsors (3)

Lead Sponsor	Collaborator
Rete Oncologica Piemonte, Valle d'Aosta	Azienda Ospedaliera Città della Salute e della Scienza di Torino, Compagnia di San Paolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-Free Survival (TFS)	Proportion of patients in active surveillance program alive and not undergoing active treatment for prostate cancer.	Up to 24 months
Secondary	Quality of Life	Measured through validated questionnaire EORTC QLQ-C30 at baseline and every six months during the first 2 years.	Up to 24 months
Secondary	Quality of Life	Measured through validated questionnaire QLQ-PR25 at baseline and every six months during the first 2 years.	Up to 24 months
Secondary	Quality of Life	Measured through validated questionnaire IPSS at baseline and every six months during the first 2 years.	Up to 24 months
Secondary	Quality of Life	Measured through validated questionnaire IIEF-5 at baseline and every six months during the first 2 years.	Up to 24 months
Secondary	Quality of Life	Measured through validated questionnaire HADS at baseline and every six months during the first 2 years.	Up to 24 months
Secondary	Quality of Life	Measured through validated questionnaire EuroQol-5D at baseline and every six months during the first 2 years.	Up to 24 months
Secondary	Quality of Life	Measured through validated questionnaire MHLC -Form C at baseline and every six months during the first 2 years.	Up to 24 months
Secondary	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	Up to 24 months

External Links

•   https://start.epiclin.it/home