Status:
COMPLETED
Active Surveillance or Radical Treatment for Newly Diagnosed Patients With a Localized, Low Risk, Prostate Cancer START
Lead Sponsor:
Rete Oncologica Piemonte, Valle d'Aosta
Collaborating Sponsors:
Compagnia di San Paolo
A.O.U. Città della Salute e della Scienza
Conditions:
Prostatic Neoplasm
Eligibility:
MALE
18+ years
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 locali...
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 partic...
Eligibility Criteria
Inclusion
- I
- 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.
Exclusion
- Patients previously treated for prostate cancer.
- Patients not willing to undergo radical treatments (surgery or radiotherapy).
Key Trial Info
Start Date :
May 15 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
850 Patients enrolled
Trial Details
Trial ID
NCT03348722
Start Date
May 15 2015
End Date
March 1 2023
Last Update
March 31 2023
Active Locations (1)
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1
Oncolgy Network of Piemonte and Valle d'Aosta - Turin
Turin, Italy, 10126