Overview

This trial is active, not recruiting.

Condition postoperative or postradiation adjuvant androgen deprivation therapy in locally advanced prostate cancer (high and very high risk) patients
Sponsor AstraZeneca
Start date July 2014
End date December 2016
Trial size 200 participants
Trial identifier NCT02155998, NIS-ORU-XXX-2014/2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.

Primary Outcomes

Measure
Evaluation of adjuvant endocrine therapy: drugs used for androgen deprivation therapy, regimen, dose, duration
time frame: up to 15 months after LSI

Secondary Outcomes

Measure
Data collection of patients characteristics (age, race, co-morbidities, family history of prostate cancer)
time frame: 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)
time frame: up to 15 months after LSI
Proportion of patients with double increase in PSA level during 1 year follow-up
time frame: up to 15 months after LSI
Proportion of progression-free patients after 1 year follow-up
time frame: up to 15 months after LSI
Proportion of patients with disease progression after 1 year follow-up
time frame: up to 15 months after LSI
Proportion of patients having biochemical relapse after 1 year follow-up
time frame: up to 15 months after LSI
Proportion of patients having clinical relapse (local or metastatic) after 1 year follow-up
time frame: up to 15 months after LSI
Evaluation of deaths among BRCAm+ patient
time frame: up to 15 months after LSI

Eligibility Criteria

Male participants of any age.

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

Additional Information

Official title A Non-interventional Study of Postoperative or Post-Radiation trEatment Habits in Locally adVanced Prostate Cancer patiENTs (High Risk)- PREVENT
Principal investigator Boris Alexeev
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.