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

NCT03348722 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 850

Last updated 2023-03-31

No results posted yet for this study

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.

Conditions

  • Prostatic Neoplasm

Interventions

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

Sponsors & Collaborators

  • Compagnia di San Paolo

    collaborator OTHER

  • A.O.U. Città della Salute e della Scienza

    collaborator OTHER

  • Rete Oncologica Piemonte, Valle d'Aosta

    lead OTHER

Principal Investigators

  • Oscar Bertetto, MD · Oncology Network of Piedmont and Valle d'Aosta

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-15
Primary Completion
2021-12-31
Completion
2023-03-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03348722 on ClinicalTrials.gov