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Completed

NCT Number: NCT02155998

Non-Interventional Study 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.

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Key information

Conditions

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

Sex eligibility

Male

Study type

Observational

Primary location

Research Site, Balashikha, Russia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluation of adjuvant endocrine therapy: drugs used for androgen deprivation therapy, regimen, dose, duration

    Time frame: up to 15 months after LSI

    Evaluation of adjuvant endocrine therapy: drugs used for androgen deprivation therapy, regimen, dose, duration

Secondary outcomes

  1. 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 patients characteristics (age, race, co-morbidities, family history of prostate cancer)

  2. 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

    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)

  3. Proportion of patients with double increase in PSA level during 1 year follow-up

    Time frame: up to 15 months after LSI

    Proportion of patients with double increase in PSA level during 1 year follow-up

  4. Proportion of progression-free patients after 1 year follow-up

    Time frame: up to 15 months after LSI

    Proportion of progression-free patients after 1 year follow-up

  5. Proportion of patients with disease progression after 1 year follow-up

    Time frame: up to 15 months after LSI

    Proportion of patients with disease progression after 1 year follow-up

  6. Proportion of patients having biochemical relapse after 1 year follow-up

    Time frame: up to 15 months after LSI

    Proportion of patients having biochemical relapse after 1 year follow-up

  7. Proportion of patients having clinical relapse (local or metastatic) 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

  8. Evaluation of deaths among BRCAm+ patient

    Time frame: up to 15 months after LSI

    Evaluation of deaths among BRCAm+ patient

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: PREVENT

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 4, 2014
Registry last updated
Apr 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.