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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

850 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-15

Study Completion Date

2023-03-01

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.

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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.

Conditions

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Prostatic Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Active surveillance

Newly diagnosed low risk prostate cancer patients managed according to an active surveillance program

Active surveillance

Intervention Type OTHER

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

Radical prostatectomy

Newly diagnosed low risk prostate cancer patients undergoing radical prostatectomy

Radical prostatectomy

Intervention Type PROCEDURE

Radical prostatectomy (open, laparoscopic or robotic)

Radiotherapy

Newly diagnosed low risk prostate cancer patients undergoing radiotherapy (external or brachitherapy)

Radiotherapy

Intervention Type RADIATION

External radical radiotherapy or brachitherapy

Other radical treatment

Newly diagnosed low risk prostate cancer patients undergoing other radical treatments (HIFU, cryotherapy, others)

Other radical treatments

Intervention Type PROCEDURE

High intensity focal ultrasound, cryotherapy, others

Interventions

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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

Intervention Type OTHER

Radical prostatectomy

Radical prostatectomy (open, laparoscopic or robotic)

Intervention Type PROCEDURE

Radiotherapy

External radical radiotherapy or brachitherapy

Intervention Type RADIATION

Other radical treatments

High intensity focal ultrasound, cryotherapy, others

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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.