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

Rete Oncologica Piemonte, Valle d'Aosta

Status: Completed

Conditions: Prostatic Neoplasm

Treatments: Other: Active surveillance; Procedure: Other radical treatments; Radiation: Radiotherapy; Procedure: Radical prostatectomy

Study type: Observational

Funder types: Other

Identifiers

NCT03348722

START

Details and patient eligibility

About

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.

Full 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.

Enrollment: 850 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

850 participants in 4 patient groups

Active surveillance

Description:

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

Treatment:

Other: Active surveillance

Radical prostatectomy

Description:

Newly diagnosed low risk prostate cancer patients undergoing radical prostatectomy

Treatment:

Procedure: Radical prostatectomy

Radiotherapy

Description:

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

Treatment:

Radiation: Radiotherapy

Other radical treatment

Description:

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

Treatment:

Procedure: Other radical treatments