Clinical trial · Observational
Non-Interventional Study PREVENT
A Non-interventional Study of Postoperative or Post-Radiation trEatment Habits in Locally adVanced Prostate Cancer patiENTs (High Risk)- PREVENT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postoperative or Postradiation Adjuvant Androgen Deprivation Therapy in Locally Advanced Prostate Cancer (High and Very High Risk) Patients | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- 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.
Primary outcomes (1)
- measure
- Evaluation of adjuvant endocrine therapy: drugs used for androgen deprivation therapy, regimen, dose, duration
- timeFrame
- up to 15 months after LSI
- description
- Evaluation of adjuvant endocrine therapy: drugs used for androgen deprivation therapy, regimen, dose, duration
Secondary outcomes (8)
- measure
- Data collection of patients characteristics (age, race, co-morbidities, family history of prostate cancer)
- timeFrame
- up to 15 months after LSI
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (0)
Data not yet available