Postoperative or Postradiation Adjuvant Androgen Deprivation Therapy in Locally Advanced Prostate Cancer (High and Very High Risk) PatientsPREVENTNCT02155998
Non-Interventional Study PREVENT
An observational study of Postoperative or Postradiation Adjuvant Androgen Deprivation Therapy in Locally Advanced Prostate Cancer (High and Very High Risk) Patients, run by AstraZeneca at 14 sites in Russia.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Postoperative or Postradiation Adjuvant Androgen Deprivation Therapy in Locally Advanced Prostate Cancer (High and Very High Risk) Patients
- How many people
- 200 participants
- Where
- 14 sitesRussia
- Study dates
- 16 Jul 2014to 14 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Russia14 sites
Research Site
Balashikha
Research Site
Belgorod
Research Site
Izhevsk
Research Site
Krasnoyarsk
Research Site
Moscow
Research Site
Novosibirsk
Research Site
Omsk
Research Site
Perm
Research Site
Rostov-on-Don
Research Site
Saint Petersburg
Research Site
Samara
Research Site
Tula
Research Site
Tyumen
Research Site
Vladimir
About this study
Official title: 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.
Read the 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.
- Keywords
- prostate adenocarcinoma, locally advanced prostate cancer with high and very high risk of recurrence, adjuvant endocrine treatment, prostate specific antigen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 15 months after LSI
Secondary outcomes (8)
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 15 months after LSI
Evaluation of deaths among BRCAm+ patient
Evaluation of deaths among BRCAm+ patient
Measured: up to 15 months after LSI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study start16 Jul 2014
- Primary completion14 Dec 2016
- Study completion14 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative or Postradiation Adjuvant Androgen Deprivation Therapy in Locally Advanced Prostate Cancer (High and Very High Risk) PatientsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karin Otter, Study director, AstraZenecaBoris Alexeev, Principal investigator, Moscow Research Institute of Oncology named after PA HerzenVsevolod Matveev, Principal investigator, Russian Cancer Research Center named after NN Blokhin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155998
- Sponsor's protocol ID
- NIS-ORU-XXX-2014/2
- Acronym
- PREVENT
- Status last verified
- Apr 2019
- First submitted
- 3 Jun 2014
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study of Postoperative or Post-Radiation trEatment Habits in Locally adVanced Prostate Cancer patiENTs (High Risk)- PREVENT
- ClinicalTrials.gov ID
- NCT02155998
- Acronym / sponsor ID
- PREVENT / NIS-ORU-XXX-2014/2
- Keywords
- prostate adenocarcinoma, locally advanced prostate cancer with high and very high risk of recurrence, adjuvant endocrine treatment, prostate specific antigen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2014 (actual)
- Primary completion
- 14 Dec 2016 (actual)
- Study completion
- 14 Dec 2016 (actual)
- First posted
- 4 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
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 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
Proportion of patients with double increase in PSA level during 1 year follow-up
Time frame: up to 15 months after LSI
Proportion of progression-free patients after 1 year follow-up
Time frame: up to 15 months after LSI
Proportion of patients with disease progression after 1 year follow-up
Time frame: up to 15 months after LSI
Proportion of patients having biochemical relapse 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
Time frame: up to 15 months after LSI
Evaluation of deaths among BRCAm+ patient
Time frame: up to 15 months after LSI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Otter study director
AstraZeneca
Boris Alexeev principal investigator
Moscow Research Institute of Oncology named after PA Herzen
Vsevolod Matveev principal investigator
Russian Cancer Research Center named after NN Blokhin
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative or Postradiation Adjuvant Androgen Deprivation Therapy in Locally Advanced Prostate Cancer (High and Very High Risk) Patients, run by AstraZeneca at 14 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of adjuvant endocrine therapy: drugs used for androgen deprivation therapy, regimen, dose, duration (time frame: up to 15 months after LSI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.