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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Karin Otter | AstraZeneca | Study Director |
| Boris Alexeev | Moscow Research Institute of Oncology named after PA Herzen | Principal Investigator |
| Vsevolod Matveev | Russian Cancer Research Center named after NN Blokhin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Balashikha | Russia | ||||
| Research Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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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 |
| Belgorod |
| Russia |
| Research Site | Izhevsk | Russia |
| Research Site | Krasnoyarsk | Russia |
| Research Site | Moscow | Russia |
| Research Site | Novosibirsk | Russia |
| Research Site | Omsk | Russia |
| Research Site | Perm | Russia |
| Research Site | Rostov-on-Don | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Samara | Russia |
| Research Site | Tula | Russia |
| Research Site | Tyumen | Russia |
| Research Site | Vladimir | Russia |