Non-Interventional Study PREVENT (PREVENT)

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

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Russian Federation
  • Balashikha, Russian Federation
    • Research Site
  • Belgorod, Russian Federation
    • Research Site
  • Izhevsk, Russian Federation
    • Research Site
  • Krasnoyarsk, Russian Federation
    • Research Site
  • Moscow, Russian Federation
    • Research Site
  • Novosibirsk, Russian Federation
    • Research Site
  • Omsk, Russian Federation
    • Research Site
  • Perm, Russian Federation
    • Research Site
  • Rostov-on-Don, Russian Federation
    • Research Site
  • Samara, Russian Federation
    • Research Site
  • St.Petersburg, Russian Federation
    • Research Site
  • Tula, Russian Federation
    • Research Site
  • Tumen, Russian Federation
    • Research Site
  • Vladimir, Russian Federation
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Male 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
PREVENT study patients; 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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Boris Alexeev, Moscow Research Institute of Oncology named after PA Herzen; Principal Investigator: Vsevolod Matveev, Russian Cancer Research Center named after NN Blokhin

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 16, 2014
• Primary Completion (ACTUAL): December 14, 2016
• Study Completion (ACTUAL): December 14, 2016

Study Registration Dates

• First Submitted: June 3, 2014
• First Submitted That Met QC Criteria: June 3, 2014
• First Posted (ESTIMATE): June 4, 2014

Study Record Updates

• Last Update Posted (ACTUAL): April 11, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: prostate adenocarcinoma, locally advanced prostate cancer with high and very high risk of recurrence, adjuvant endocrine treatment, prostate specific antigen
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: NIS-ORU-XXX-2014/2