Non-Interventional Study PREVENT

Study Overview
=================
Brief Summary
-----------------
This is a multicentre, non-interventional, prospective study to be carried out in representative medical institutions in order to get the information on administration of postoperative and post-radiation adjuvant androgen deprivation therapy (including go / no go decision, regimens, dosages and duration) used in locally advanced prostate cancer patients with high and very high risk of recurrence in Russia.

Detailed Description
-----------------
This is a multicentre, non-interventional, prospective study to be carried out in representative medical institutions in order to get the information on administration of postoperative and post-radiation adjuvant androgen deprivation therapy (including go / no go decision, regimens, dosages and duration) used in locally advanced prostate cancer patients with high and very high risk of recurrence in Russia. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice. It is planned to enrol 200 subjects in up to 30 sites in Russian Federation. The average number of patients per site is planned as 6 - 10; there are no restrictions on minimum and maximum number of subjects per site in this study.

Official Title
-----------------
A Non-interventional Study of Postoperative or Post-Radiation trEatment Habits in Locally adVanced Prostate Cancer patiENTs (High Risk)- PREVENT

Conditions
-----------------
Postoperative or Postradiation Adjuvant Androgen Deprivation Therapy in Locally Advanced Prostate Cancer (High and Very High Risk) Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The voluntarily given informed consent, confirmed by the Informed Consent Form, properly signed by both the subject and the investigator. Locally advanced stage of PCa (stage T3-T4, Nx-N0, M0: prostate adenocarcinoma with extracapsular invasion (T3a) or invasion to the seminal vesicles (T3b), invasion to adjacent structures (T4) but without lymphatic invasion (N0) nor metastasis (M0)) Prostatectomy or radiotherapy completed within 3 months prior to the study enrolment High (T3a or Gleason score = 8-10 or PCA >20 ng/ml) and very high (T3b-T4) risk of recurrence Histologically confirmed diagnosis of prostate adenocarcinoma Exclusion Criteria: Patients participating in clinical trials Any medical condition which on the opinion of the investigator may interfere with the patient's participation in the study, e.g. severe non-malignant concomitant disease which can affect life expectancy Evidence of metastatic disease on imaging studies
Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PREVENT study patients<br>Patients with locally advanced prostate cancer with high and very high risk of recurrence, who underwent surgery or radiotherapy within 3 months prior to enrolment, 18 years and older, consented to participate in this non-interventional study, being treated for prostate cancer in the oncology institutions / departments in the Russian Federation. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of adjuvant endocrine therapy: drugs used for androgen deprivation therapy, regimen, dose, duration | Evaluation of adjuvant endocrine therapy: drugs used for androgen deprivation therapy, regimen, dose, duration | up to 15 months after LSI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data collection of patients characteristics (age, race, co-morbidities, family history of prostate cancer) | Data collection of patients characteristics (age, race, co-morbidities, family history of prostate cancer) | up to 15 months after LSI | 
| Data collection of disease information ( disease stage - TNM, histology, Gleason score, PSA level, prior prostate cancer surgery/radiotherapy -types, imaging techniques, neoadjuvant and adjuvant therapy(medications by groups, orchidectomy) | Data collection of disease information ( disease stage - TNM, histology, Gleason score, PSA level, prior prostate cancer surgery/radiotherapy -types, imaging techniques, neoadjuvant and adjuvant therapy(medications by groups, orchidectomy) | up to 15 months after LSI | 
| Proportion of patients with double increase in PSA level during 1 year follow-up | Proportion of patients with double increase in PSA level during 1 year follow-up | up to 15 months after LSI | 
| Proportion of progression-free patients after 1 year follow-up | Proportion of progression-free patients after 1 year follow-up | up to 15 months after LSI | 
| Proportion of patients with disease progression after 1 year follow-up | Proportion of patients with disease progression after 1 year follow-up | up to 15 months after LSI | 
| Proportion of patients having biochemical relapse after 1 year follow-up | Proportion of patients having biochemical relapse after 1 year follow-up | up to 15 months after LSI | 
| Proportion of patients having clinical relapse (local or metastatic) after 1 year follow-up | Proportion of patients having clinical relapse (local or metastatic) after 1 year follow-up | up to 15 months after LSI | 
| Evaluation of deaths among BRCAm+ patient | Evaluation of deaths among BRCAm+ patient | up to 15 months after LSI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate adenocarcinoma, locally advanced prostate cancer with high and very high risk of recurrence, adjuvant endocrine treatment, prostate specific antigen