Prostate CancerPREDICTNCT04269512
Role of Lymphnode Dissection in Men With Prostate Cancer Treated With Radical Prostatectomy
A study testing lymph node dissection in people with Prostate Cancer, run by Martini-Klinik am UKE GmbH at 1 site in Germany.
Trial summary
Currently, lymph node dissection is standard of care during prostatectomy of intermediate risk tumors at the Martini Clinic. It allows the assessment of possible but unlikely lymph nodes metastases. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,650 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2019to Dec 2029
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- localized intermediate risk prostate cancer (intermediate risk (PSA> 10 ng / ml - 20 ng / ml or Gleason score 7 or cT category 2b)
- scheduled for open radical prostatectomie or DaVinci prostatectomie
Who cannot join
- American Society of Anesthesiology Classification> 3
- Existing contraindications for performing a lymph node dissection
- Neoadjuvant hormone therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Trial to Evaluate the Prognostic Role of Lymphnode Dissection in Men With Prostate Cancer Treated With Radical Prostatectomy (Predict-Study)
Currently, lymph node dissection is standard of care during prostatectomy of intermediate risk tumors at the Martini Clinic. It allows the assessment of possible but unlikely lymph nodes metastases. In case of lymph node metastasis, depending on the number of affected lymph nodes, an adjuvant radiation with or without additional hormone therapy may be discussed in order to stop or delay further progression of the disease.
Since the procedure carries additional risks, it is controversial. The risks include prolonged surgery duration, injury of vessels and nerves, as well as disorders of lymphatic circulation after surgery. Moreover, formation of lymphoceles (accumulation of lymph fluid in the tissue) are common, which may result in soft tissue swelling, thrombosis, inflammation and additional surgical procedures.
Read more
Therefore, the aim of this study is to evaluate whether the removal of the lymph nodes during prostatectomy positively influences the course of the disease in patients with intermediate risk prostate cancer, or if the lymph node dissection does not have any influence on the recurrence of the disease and therefore further therapies.
In this case, the omission of lymph node dissection may avoid an unnecessary expansion of the operation and the potentially associated side effects linked to it. This is particularly of interest considering the rapidly advancing technical possibilities, both in imaging and in the treatment of prostate cancer, since this enables an earlier and more individual intervention in the case of recurrence.
Read the detailed description
The significance of lymph node dissection in radical prostatectomy has not been conclusively clarified. If a radical prostatectomy is planned, the question occurs if the additional pelvic lymph node dissection (LND) is justified and to what extent it should be performed (limited LND, standard LND or extended LND). On the one hand, the detection of lymph node metastases is associated with a significantly worse course of the tumor disease and requires immediate or delayed hormone-ablative therapy. On the other hand, the lymph node dissection is associated with risks (lymphoceles, thromboses, lymphedema), so that the indication in negative lymph node findings appears questionable. It must be weighed between the diagnostic advantage and the possibility of increased morbidity due to the lymphadenectomy. For localized intermediate risk prostate cancer (PSA> 10 ng / ml - 20 ng / ml or Gleason score 7 or cT category 2b ), there are currently no recommendations for performing a lymph node dissection during prostatectomy.
- Conditions
- Prostate Cancer
- Being tested
- lymph node dissection
- Keywords
- prostatectomy, lymphadenectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymph node dissectionProcedure or surgery
At least 10 lymph nodes must be removed.
| Study group | Role | What they receive |
|---|---|---|
| extended lymph node dissection | Active comparator | Patients randomized to arm A undergo bilateral lymph node dissection in the pelvic area as part of prostatectomy. At least 10 lymph nodes must be removed. Receives: Procedure: lymph node dissection |
| standard without lymph node dissection | No intervention | Application of standardized surgical technique without extensive lymph node dissection. If, contrary to expectation, intraoperative suspicion of lymphogenic metastasis results, a lymph node dissection is performed and the patient is excluded from the study (freedom of the surgeon). |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA recurrence rate
The PSA recurrence rate in patients with intermediate risk prostate cancer treated with radical prostatectomy with or without additional lymph node dissection at three years of follow up (PSA recurrence: PSA value ≥ 0.2 ng / ml).
Measured: 36 months after surgery
Secondary outcomes (3)
Incidence of lymphoceles and complications
(Clavien classification)
Measured: 6 months after surgery
quality of life including continence and potency
Questionnaire Expanded prostate cancer index composite (EPIC-26)
Measured: 6, 12, 24, 36 months after surgery
metastasis-free survival
diagnosis of metastasis after prostatectomy by radiological assessment
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start15 Oct 2019
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martini-Klinik am UKE GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Graefen, Principal investigator, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269512
- Sponsor's protocol ID
- PREDICT_MK2019
- Acronym
- PREDICT
- Status last verified
- Jan 2026
- First submitted
- 5 Feb 2020
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial to Evaluate the Prognostic Role of Lymphnode Dissection in Men With Prostate Cancer Treated With Radical Prostatectomy (Predict-Study)
- ClinicalTrials.gov ID
- NCT04269512
- Acronym / sponsor ID
- PREDICT / PREDICT_MK2019
- Conditions
- Prostate Cancer
- Keywords
- prostatectomy, lymphadenectomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,650 participants (estimated)
- Lead sponsor
- Martini-Klinik am UKE GmbHUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 13 Feb 2020 (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.
Currently, lymph node dissection is standard of care during prostatectomy of intermediate risk tumors at the Martini Clinic. It allows the assessment of possible but unlikely lymph nodes metastases. In case of lymph node metastasis, depending on the number of affected lymph nodes, an adjuvant radiation with or without additional hormone therapy may be discussed in order to stop or delay further progression of the disease.
Since the procedure carries additional risks, it is controversial. The risks include prolonged surgery duration, injury of vessels and nerves, as well as disorders of lymphatic circulation after surgery. Moreover, formation of lymphoceles (accumulation of lymph fluid in the tissue) are common, which may result in soft tissue swelling, thrombosis, inflammation and additional surgical procedures.
Therefore, the aim of this study is to evaluate whether the removal of the lymph nodes during prostatectomy positively influences the course of the disease in patients with intermediate risk prostate cancer, or if the lymph node dissection does not have any influence on the recurrence of the disease and therefore further therapies.
In this case, the omission of lymph node dissection may avoid an unnecessary expansion of the operation and the potentially associated side effects linked to it. This is particularly of interest considering the rapidly advancing technical possibilities, both in imaging and in the treatment of prostate cancer, since this enables an earlier and more individual intervention in the case of recurrence.
Detailed description
The significance of lymph node dissection in radical prostatectomy has not been conclusively clarified. If a radical prostatectomy is planned, the question occurs if the additional pelvic lymph node dissection (LND) is justified and to what extent it should be performed (limited LND, standard LND or extended LND). On the one hand, the detection of lymph node metastases is associated with a significantly worse course of the tumor disease and requires immediate or delayed hormone-ablative therapy. On the other hand, the lymph node dissection is associated with risks (lymphoceles, thromboses, lymphedema), so that the indication in negative lymph node findings appears questionable. It must be weighed between the diagnostic advantage and the possibility of increased morbidity due to the lymphadenectomy. For localized intermediate risk prostate cancer (PSA> 10 ng / ml - 20 ng / ml or Gleason score 7 or cT category 2b ), there are currently no recommendations for performing a lymph node dissection during prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extended lymph node dissection | Active comparator | Procedure: lymph node dissectionPatients randomized to arm A undergo bilateral lymph node dissection in the pelvic area as part of prostatectomy. At least 10 lymph nodes must be removed. |
| standard without lymph node dissection | No intervention | –Application of standardized surgical technique without extensive lymph node dissection. If, contrary to expectation, intraoperative suspicion of lymphogenic metastasis results, a lymph node dissection is performed and the patient is excluded from the study (freedom of the surgeon). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- localized intermediate risk prostate cancer (intermediate risk (PSA> 10 ng / ml - 20 ng / ml or Gleason score 7 or cT category 2b)
- scheduled for open radical prostatectomie or DaVinci prostatectomie
Key exclusion criteria (3 listed)
- American Society of Anesthesiology Classification> 3
- Existing contraindications for performing a lymph node dissection
- Neoadjuvant hormone therapy
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 |
|---|---|---|
| lymph node dissectionAt least 10 lymph nodes must be removed. | Procedure or surgery | extended lymph node dissection |
Primary outcome
PSA recurrence rate
Time frame: 36 months after surgery
The PSA recurrence rate in patients with intermediate risk prostate cancer treated with radical prostatectomy with or without additional lymph node dissection at three years of follow up (PSA recurrence: PSA value ≥ 0.2 ng / ml).
3 secondary outcomes
Incidence of lymphoceles and complications
Time frame: 6 months after surgery
quality of life including continence and potency
Time frame: 6, 12, 24, 36 months after surgery
metastasis-free survival
Time frame: 36 months
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 12 Jan 2026.
- HomepageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Markus Graefen principal investigator
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lymph node dissection in people with Prostate Cancer, run by Martini-Klinik am UKE GmbH at 1 site in Germany.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. 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 Germany. 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?
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?
PSA recurrence rate (time frame: 36 months after surgery). 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 12 Jan 2026.