Prostate CancerNCT04146077
Active Surveillance for Low Risk Prostate Cancer
An observational study of Prostate Cancer and Prostate Adenocarcinoma, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
An active surveillance protocol for patients diagnosed low-risk prostate cancer will be held. We plan to use PSA (prostate-specific antigen) testing, DRE (digital rectal examination), TRUS (transrectal ultrasound), MRI (magnetic resonance imaging) and follow-up biopsies to monitor patients and detect cancer… Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2019to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with low risk prostate cancer, who gave informed consent to undergo active surveillance and to participate in this study, and had no previous treatment of prostate cancer or surgery at the prostate.
Who may be able to join
- prostate adenocarcinoma verified by at least 12 core biopsy
- patient must understand the sense of research, agree to participate and sign a form of agreement
- low oncological risk according to EAU (European Association of Urology) Guidelines: stage T1-T2a, PSA<10 ng/ml, ISUP (International Society of Urological Pathologists score)=1 (Gleason score 3+3=6)
- not more than 33% cores with adenocarcinoma
Who cannot join
- previous treatment of prostate cancer
- other prostatic malignant neoplasms
- other oncological diseases
- treatment with 5-alfa-reductase inhibitors
- patient's refuse to continue study
- patient's desire to begin treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Institute for Urology and Reproductive Health, Sechenov University.
Moscow, 119991
Dmitry Enikeev, MD, PhD, +7 925 517 79 26, enikeev-dv@1msmu.ru
About this study
Official title: Active Surveillance Methodology for Low Risk Prostate Cancer
An active surveillance protocol for patients diagnosed low-risk prostate cancer will be held. We plan to use PSA (prostate-specific antigen) testing, DRE (digital rectal examination), TRUS (transrectal ultrasound), MRI (magnetic resonance imaging) and follow-up biopsies to monitor patients and detect cancer progression in time.
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Keywords
- prostate cancer, active surveillance, low oncological risk
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
cancer progression
Number of patients who had one of the following signs of cancer progression: new lesion on DRE proved by biopsy, or histological upgrade on follow-up biopsy, or involvement of more than 33% cores on follow-up biopsy
Measured: 5 years
Secondary outcomes (1)
surgical treatment due to infravesical obstruction by BPH
Number of patients who underwent any treatment due to BPH: endoscopic procedures, or simple prostatectomy, or punction cystostomy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start1 Oct 2019
- Primary completionOct 2024 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Moscow Regional Research and Clinical Institute (MONIKI), Pirogov Russian National Research Medical University
- Responsible party
- Principal investigator, Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146077
- Sponsor's protocol ID
- Sechenov-AS-19
- Status last verified
- Jul 2021
- First submitted
- 28 Oct 2019
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Surveillance Methodology for Low Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT04146077
- Acronym / sponsor ID
- Sechenov-AS-19
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Keywords
- prostate cancer, active surveillance, low oncological risk
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Collaborators
- Moscow Regional Research and Clinical Institute (MONIKI), Pirogov Russian National Research Medical University
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 31 Oct 2019 (actual)
- 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.
An active surveillance protocol for patients diagnosed low-risk prostate cancer will be held. We plan to use PSA (prostate-specific antigen) testing, DRE (digital rectal examination), TRUS (transrectal ultrasound), MRI (magnetic resonance imaging) and follow-up biopsies to monitor patients and detect cancer progression in time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with low risk prostate cancer, who gave informed consent to undergo active surveillance and to participate in this study, and had no previous treatment of prostate cancer or surgery at the prostate.
Key inclusion criteria (4 listed)
- prostate adenocarcinoma verified by at least 12 core biopsy
- patient must understand the sense of research, agree to participate and sign a form of agreement
- low oncological risk according to EAU (European Association of Urology) Guidelines: stage T1-T2a, PSA<10 ng/ml, ISUP (International Society of Urological Pathologists score)=1 (Gleason score 3+3=6)
- not more than 33% cores with adenocarcinoma
Key exclusion criteria (6 listed)
- previous treatment of prostate cancer
- other prostatic malignant neoplasms
- other oncological diseases
- treatment with 5-alfa-reductase inhibitors
- patient's refuse to continue study
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
cancer progression
Time frame: 5 years
Number of patients who had one of the following signs of cancer progression: new lesion on DRE proved by biopsy, or histological upgrade on follow-up biopsy, or involvement of more than 33% cores on follow-up biopsy
1 secondary outcome
surgical treatment due to infravesical obstruction by BPH
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
Related trials for Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruiting
Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer
Malignant Prostate Neoplasm
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
RecruitingObservational study
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Prostatic Neoplasms, Prostate Cancer
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
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.
Institute for Urology and Reproductive Health, Sechenov University.
Moscow, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Prostate Adenocarcinoma, run by I.M. Sechenov First Moscow State Medical University at 1 site 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cancer progression (time frame: 5 years). 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 22 Jul 2021.