Prostatic Neoplasm
Conditions
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)
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.
Interventions
PROCEDUREOther radical treatments
High intensity focal ultrasound, cryotherapy, others
OTHERActive 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
PROCEDURERadical prostatectomy
Radical prostatectomy (open, laparoscopic or robotic)
RADIATIONRadiotherapy
External radical radiotherapy or brachitherapy
Sponsors
Compagnia di San Paolo
A.O.U. Città della Salute e della Scienza
Rete Oncologica Piemonte, Valle d'Aosta
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-Free Survival (TFS) | Up to 24 months | Proportion of patients in active surveillance program alive and not undergoing active treatment for prostate cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | Up to 24 months | Measured through validated questionnaire EORTC QLQ-C30 at baseline and every six months during the first 2 years. |
| Cost-effectiveness | Up to 24 months | 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 |
Countries
Italy
Outcome results
None listed