Prostate Cancer Patients Undergoing Radical ProstatectomyNCT07308990
Limited Versus Extended Lymph Node Dissection During Radical Prostatectomy in Patients With Localized or Locally Advanced Prostate Cancer
A study testing Radical prostatectomy with extended / limited lymph node dissection and Radical prostatectomy with limited / no lymph node dissection in people with Prostate Cancer Patients Undergoing Radical Prostatectomy, run by N.N. Alexandrov National Cancer Centre at 1 site in Belarus.
Trial summary
This is a randomized controlled study assessing outcome of low (no or limited) versus high (limited or extended) extent of lymph node dissection in addition to radical prostatectomy in patients with operable localized or locally advanced prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Patients Undergoing Radical Prostatectomy
- What is being tested?
- Radical prostatectomy with extended / limited lymph node dissection and Radical prostatectomy with limited / no lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteBelarus
- Study dates
- 29 Oct 2025to 30 May 2032
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years.
- Histologically confirmed localized or locally advanced prostate cancer (adenocarcinoma without a neuroendocrine component).
- No evidence of metastatic spread of the tumor
- Local resectability of the tumor according to digital rectal examination and/or CT and/or MRI of the pelvis
- Patients are suitable for radical prostatectomy based on their comorbidities and life expectancy.
- Signed informed consent to participate in the study.
Who cannot join
- Presence of another active malignant invasive neoplasm.
- Contraindication to pelvic lymph node dissection (e.g., history of radiation therapy to the pelvis).
- The evidence of metastases in regional lymph nodes according to preoperative examination data (including PET/CT with PSMA).
- Severe concomitant disease limiting participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belarus1 site, 1 recruiting
- Recruiting
N.N. Alexandrov National Cancer Centre
Lyasny, Minsk Oblast, 223040
Alexander I Rolevich, Dr., 375173899538, alexander.rolevich@gmail.com
Maxim V Trunin, 375172652345, truninmaxim@gmail.com
About this study
Official title: To Develop and Implement a Method for Optimizing the Volume of Lymph Node Dissection in Radical Surgical Treatment of Localized or Locally Advanced Prostate Cancer
This is a randomized controlled study assessing outcome of low (no or limited) versus high (limited or extended) extent of lymph node dissection in addition to radical prostatectomy in patients with operable localized or locally advanced prostate cancer.
- Being tested
- Radical prostatectomy with extended / limited lymph node dissection, Radical prostatectomy with limited / no lymph node dissection
- Keywords
- prostate cancer, lymph node dissection, radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical prostatectomy with extended / limited lymph node dissectionProcedure or surgery
In patients with NCCN high or unfavorable intermediate risk prostate cancer - radical prostatectomy with extended lymph node dissection (incl. external iliac, obturator, internal iliac and common iliac nodes up to ureter bilaterally).
In patients with NCCN low or favorable intermediate risk prostate cancer - radical prostatectomy with limited lymph node dissection (incl. obturator + / - external iliac lymph nodes bilaterally).
Radical prostatectomy with limited / no lymph node dissectionProcedure or surgery
In patients with NCCN high or unfavorable intermediate risk prostate cancer - radical prostatectomy with limited lymph node dissection (incl. obturator + / - external iliac lymph nodes bilaterally). In patients with NCCN low or favorable intermediate risk prostate cancer - radical prostatectomy with no lymph nodes dissection bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| no / limited lymph node dissection | Experimental | Not described Receives: Procedure: Radical prostatectomy with limited / no lymph node dissection |
| limited / extended lymph node dissection | Experimental | Not described Receives: Procedure: Radical prostatectomy with extended / limited lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metastasis-free survival
time from randomization to first diagnosis of distant metastasis from prostate cancer
Measured: from enrollment to the end of the study at 5 years
Secondary outcomes (8)
30-day complication rate
rate of complications from the start of surgery to 30 days postoperatively graded by Clavien-Dindo
Measured: from the start of surgery to 30 days postoperatively
Perioperative events (length of surgery, intraoperative blood loss)
Measured: perioperatively
Duration of hospital stay
time from surgery to the discharge from the hospital
Measured: at first follow up visit (6-12 weeks post-surgery)
Biochemical recurrence-free survival
time from randomization to first confirmed PSA rise > / = 0.2 ng/ml
Measured: from enrollment to the end of the study at 5 years
Time to treatment
time from randomization to the first prostate cancer-related therapy
Measured: from enrollment to the end of the study at 5 years
Prostate cancer specific survival
time from randomization to death from prostate cancer
Measured: from enrollment to the end of the study at 5-7 years
Overall survival
time from randomization to to death of any cause
Measured: from enrollment to the end of the study at 5-7 years
Metastasis-free survival in subgroups of patients (NCCN risk groups, operated by individual surgeon)
time from randomization to first diagnosis of distant metastasis from prostate cancer
Measured: from enrollment to the end of the study at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start29 Oct 2025
- Primary completion30 May 2030 (estimated)
- Study completion30 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Patients Undergoing Radical ProstatectomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N.N. Alexandrov National Cancer Centre
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308990
- Sponsor's protocol ID
- 011/25
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Develop and Implement a Method for Optimizing the Volume of Lymph Node Dissection in Radical Surgical Treatment of Localized or Locally Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT07308990
- Acronym / sponsor ID
- 011/25
- Keywords
- prostate cancer, lymph node dissection, radical prostatectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- N.N. Alexandrov National Cancer CentreOther government
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- 30 May 2030 (estimated)
- Study completion
- 30 May 2032 (estimated)
- First posted
- 30 Dec 2025 (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.
This is a randomized controlled study assessing outcome of low (no or limited) versus high (limited or extended) extent of lymph node dissection in addition to radical prostatectomy in patients with operable localized or locally advanced prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no / limited lymph node dissection | Experimental | Procedure: Radical prostatectomy with limited / no lymph node dissection |
| limited / extended lymph node dissection | Experimental | Procedure: Radical prostatectomy with extended / limited lymph node dissection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age over 18 years.
- Histologically confirmed localized or locally advanced prostate cancer (adenocarcinoma without a neuroendocrine component).
- No evidence of metastatic spread of the tumor
- Local resectability of the tumor according to digital rectal examination and/or CT and/or MRI of the pelvis
- Patients are suitable for radical prostatectomy based on their comorbidities and life expectancy.
Key exclusion criteria (4 listed)
- Presence of another active malignant invasive neoplasm.
- Contraindication to pelvic lymph node dissection (e.g., history of radiation therapy to the pelvis).
- The evidence of metastases in regional lymph nodes according to preoperative examination data (including PET/CT with PSMA).
- Severe concomitant disease limiting participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical prostatectomy with extended / limited lymph node dissectionIn patients with NCCN high or unfavorable intermediate risk prostate cancer - radical prostatectomy with extended lymph node dissection (incl. external iliac, obturator, internal iliac and common iliac nodes up to ureter bilaterally). In patients with NCCN low or favorable intermediate risk prostate cancer - radical prostatectomy with limited lymph node dissection (incl. obturator + / - external iliac lymph nodes bilaterally). | Procedure or surgery | limited / extended lymph node dissection |
| Radical prostatectomy with limited / no lymph node dissectionIn patients with NCCN high or unfavorable intermediate risk prostate cancer - radical prostatectomy with limited lymph node dissection (incl. obturator + / - external iliac lymph nodes bilaterally). In patients with NCCN low or favorable intermediate risk prostate cancer - radical prostatectomy with no lymph nodes dissection bilaterally. | Procedure or surgery | no / limited lymph node dissection |
Primary outcome
Metastasis-free survival
Time frame: from enrollment to the end of the study at 5 years
time from randomization to first diagnosis of distant metastasis from prostate cancer
8 secondary outcomes
30-day complication rate
Time frame: from the start of surgery to 30 days postoperatively
Perioperative events (length of surgery, intraoperative blood loss)
Time frame: perioperatively
Duration of hospital stay
Time frame: at first follow up visit (6-12 weeks post-surgery)
Biochemical recurrence-free survival
Time frame: from enrollment to the end of the study at 5 years
Time to treatment
Time frame: from enrollment to the end of the study at 5 years
Prostate cancer specific survival
Time frame: from enrollment to the end of the study at 5-7 years
Overall survival
Time frame: from enrollment to the end of the study at 5-7 years
Metastasis-free survival in subgroups of patients (NCCN risk groups, operated by individual surgeon)
Time frame: from enrollment to the end of the study at 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 30 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical prostatectomy with extended / limited lymph node dissection and Radical prostatectomy with limited / no lymph node dissection in people with Prostate Cancer Patients Undergoing Radical Prostatectomy, run by N.N. Alexandrov National Cancer Centre at 1 site in Belarus.
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 6 inclusion and 4 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 30 Dec 2025. 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 Belarus. 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?
Metastasis-free survival (time frame: from enrollment to the end of the study at 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 30 Dec 2025.