Clinical trial NCT03348722: Active Surveillance or Radical Treatment for Newly Diagnosed Patients With a Localized, Low Risk, Prostate Cancer 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasm
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)
Lead sponsor: Rete Oncologica Piemonte, Valle d'Aosta
Sponsor class: OTHER
Collaborators: name: Compagnia di San Paolo
name: A.O.U. Città della Salute e della Scienza
First posted: 2017-11-21
Enrollment: 850
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Treatment-Free Survival (TFS)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Quality of Life
timeFrame: Up to 24 months
measure: Quality of Life
timeFrame: Up to 24 months
measure: Quality of Life
timeFrame: Up to 24 months
measure: Quality of Life
timeFrame: Up to 24 months
measure: Quality of Life
timeFrame: Up to 24 months
measure: Quality of Life
timeFrame: Up to 24 months
measure: Quality of Life
timeFrame: Up to 24 months
measure: Cost-effectiveness
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Oncolgy Network of Piemonte and Valle d'Aosta - Turin
Study officials:
affiliation: Oncology Network of Piedmont and Valle d'Aosta
name: Oscar Bertetto, MD
role: PRINCIPAL_INVESTIGATOR
References: