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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Prostatic Neoplasm

Intervention / Treatment
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* Other: Active surveillance
* Procedure: Radical prostatectomy
* Radiation: Radiotherapy
* Procedure: Other radical treatments


Participation Criteria
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Eligibility Criteria
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IInclusion Criteria: 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 Criteria: Patients previously treated for prostate cancer. Patients not willing to undergo radical treatments (surgery or radiotherapy).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active surveillance<br>Newly diagnosed low risk prostate cancer patients managed according to an active surveillance program | Other: Active surveillance<br>* 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<br>|
| Radical prostatectomy<br>Newly diagnosed low risk prostate cancer patients undergoing radical prostatectomy | Procedure: Radical prostatectomy<br>* Radical prostatectomy (open, laparoscopic or robotic)<br>|
| Radiotherapy<br>Newly diagnosed low risk prostate cancer patients undergoing radiotherapy (external or brachitherapy) | Radiation: Radiotherapy<br>* External radical radiotherapy or brachitherapy<br>|
| Other radical treatment<br>Newly diagnosed low risk prostate cancer patients undergoing other radical treatments (HIFU, cryotherapy, others) | Procedure: Other radical treatments<br>* High intensity focal ultrasound, cryotherapy, others<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Measured through validated questionnaire EORTC QLQ-C30 at baseline and every six months during the first 2 years. | Up to 24 months | 
| Quality of Life | Measured through validated questionnaire QLQ-PR25 at baseline and every six months during the first 2 years. | Up to 24 months | 
| Quality of Life | Measured through validated questionnaire IPSS at baseline and every six months during the first 2 years. | Up to 24 months | 
| Quality of Life | Measured through validated questionnaire IIEF-5 at baseline and every six months during the first 2 years. | Up to 24 months | 
| Quality of Life | Measured through validated questionnaire HADS at baseline and every six months during the first 2 years. | Up to 24 months | 
| Quality of Life | Measured through validated questionnaire EuroQol-5D at baseline and every six months during the first 2 years. | Up to 24 months | 
| Quality of Life | Measured through validated questionnaire MHLC -Form C at baseline and every six months during the first 2 years. | Up to 24 months | 
| Cost-effectiveness | 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 | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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)