Non-Interventional Study PREVENT

AstraZeneca

Status: Completed

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02155998

NIS-ORU-XXX-2014/2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The voluntarily given informed consent, confirmed by the Informed Consent Form, properly signed by both the subject and the investigator.
2. 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))
3. Prostatectomy or radiotherapy completed within 3 months prior to the study enrolment
4. High (T3a or Gleason score = 8-10 or PCA >20 ng/ml) and very high (T3b-T4) risk of recurrence
5. Histologically confirmed diagnosis of prostate adenocarcinoma

Exclusion criteria

1. Patients participating in clinical trials
2. 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
3. Evidence of metastatic disease on imaging studies

Trial design

200 participants in 1 patient group

PREVENT study patients

Description:

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.