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

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasm
• Intervention / Treatment: Other: Active surveillance; Procedure: Radical prostatectomy; Radiation: Radiotherapy; Procedure: Other radical treatments

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 Type: Observational
• Enrollment (Actual): 850

Contacts and Locations

• Study Contact: Name: Oscar Bertetto, MD; Phone Number: +39 011 633 6889; Email: segreteria@reteoncologica.it
• Study Contact Backup: Name: Giovannino Ciccone, MD; Phone Number: + 39 011 633 6857; Email: gianni.ciccone@cpo.it

Study Locations

• Italy
  • Turin, Italy, 10126
    • Oncolgy Network of Piemonte and Valle d'Aosta - Turin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed low risk prostate cancer patients resident in Piemonte or in Valle D'Aosta regions (Northern Italy)

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Active surveillance; Newly diagnosed low risk prostate cancer patients managed according to an active surveillance program	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
Radical prostatectomy; Newly diagnosed low risk prostate cancer patients undergoing radical prostatectomy	Procedure: Radical prostatectomy; Radical prostatectomy (open, laparoscopic or robotic)
Radiotherapy; Newly diagnosed low risk prostate cancer patients undergoing radiotherapy (external or brachitherapy)	Radiation: Radiotherapy; External radical radiotherapy or brachitherapy
Other radical treatment; Newly diagnosed low risk prostate cancer patients undergoing other radical treatments (HIFU, cryotherapy, others)	Procedure: Other radical treatments; High intensity focal ultrasound, cryotherapy, others

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Quality of Life	Measured through validated questionnaire QLQ-PR25 at baseline and every six months during the first 2 years.	Up to 24 months
Quality of Life	Measured through validated questionnaire IPSS at baseline and every six months during the first 2 years.	Up to 24 months
Quality of Life	Measured through validated questionnaire IIEF-5 at baseline and every six months during the first 2 years.	Up to 24 months
Quality of Life	Measured through validated questionnaire HADS at baseline and every six months during the first 2 years.	Up to 24 months
Quality of Life	Measured through validated questionnaire EuroQol-5D at baseline and every six months during the first 2 years.	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.	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	Up to 24 months

Collaborators and Investigators

• Sponsor: Rete Oncologica Piemonte, Valle d'Aosta
• Collaborators: Azienda Ospedaliera Città della Salute e della Scienza di Torino; Compagnia di San Paolo
• Investigators: Principal Investigator: Oscar Bertetto, MD, Oncology Network of Piedmont and Valle d'Aosta

Publications and helpful links

Helpful Links

• https://start.epiclin.it/home

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2015
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• 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)
• Additional Relevant MeSH Terms: Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Neoplasms; Prostatic Neoplasms
• Other Study ID Numbers: START

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No