Postoperative or Postradiation Adjuvant Androgen Deprivation Therapy in Locally Advanced Prostate Cancer (High and Very High Risk) Patients Clinical Trial
— PREVENTOfficial title:
A Non-interventional Study of Postoperative or Post-Radiation trEatment Habits in Locally adVanced Prostate Cancer patiENTs (High Risk)- PREVENT
| Verified date | April 2019 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | December 14, 2016 |
| Est. primary completion date | December 14, 2016 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Research Site | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Evaluation of deaths among BRCAm+ patient | Evaluation of deaths among BRCAm+ patient | up to 15 months after LSI |