NCT03348722

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
850

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

6.6 years

First QC Date

June 19, 2017

Last Update Submit

March 30, 2023

Conditions

Prostatic Neoplasm

Keywords

Active surveillanceLow risk prostate cancerProstatic neoplasm/therapy (MESH)Prostatic neoplasm/surgery (MESH)Prostatic neoplasm/radiotherapy (MESH)Prostatectomy (MESH)Quality of life (MESH)Costs and Cost Analysis (MESH)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Quality of Life

    Up to 24 months

  • Quality of Life

    Up to 24 months

  • Quality of Life

    Up to 24 months

  • Quality of Life

    Up to 24 months

  • Quality of Life

    Up to 24 months

  • +3 more secondary outcomes

Study Arms (4)

Active surveillance

Newly diagnosed low risk prostate cancer patients managed according to an active surveillance program

Other: Active surveillance

Radical prostatectomy

Newly diagnosed low risk prostate cancer patients undergoing radical prostatectomy

Procedure: Radical prostatectomy

Radiotherapy

Newly diagnosed low risk prostate cancer patients undergoing radiotherapy (external or brachitherapy)

Radiation: Radiotherapy

Other radical treatment

Newly diagnosed low risk prostate cancer patients undergoing other radical treatments (HIFU, cryotherapy, others)

Procedure: Other radical treatments

Interventions

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

Active surveillance
Radical prostatectomyPROCEDURE

Radical prostatectomy (open, laparoscopic or robotic)

Radical prostatectomy
RadiotherapyRADIATION

External radical radiotherapy or brachitherapy

Radiotherapy
Other radical treatmentsPROCEDURE

High intensity focal ultrasound, cryotherapy, others

Other radical treatment

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)
  • Residence in Piemonte or Valle D'Aosta regions;
  • Patients suitable for radical treatment (surgery or radiotherapy);
  • Age at diagnosis \<= 75 years or \>75 years if fragility assessment (measured with the G8 score)\> = 14;
  • Patients suitability for expressing a valid consent to participate in the study.

You may not qualify if:

  • Patients previously treated for prostate cancer.
  • Patients not willing to undergo radical treatments (surgery or radiotherapy).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncolgy Network of Piemonte and Valle d'Aosta - Turin

Turin, 10126, Italy

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Watchful WaitingRadiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationTherapeutics

Study Officials

  • Oscar Bertetto, MD

    Oncology Network of Piedmont and Valle d'Aosta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2017

First Posted

November 21, 2017

Study Start

May 15, 2015

Primary Completion

December 31, 2021

Study Completion

March 1, 2023

Last Updated

March 31, 2023

Record last verified: 2023-03

Locations

IT(1)