Role of Lymphnode Dissection in Men With Prostate Cancer Treated With Radical Prostatectomy (PREDICT)
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|ClinicalTrials.gov Identifier: NCT04269512|
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : October 28, 2021
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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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: lymph node dissection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3650 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Trial to Evaluate the Prognostic Role of Lymphnode Dissection in Men With Prostate Cancer Treated With Radical Prostatectomy (Predict-Study)|
|Actual Study Start Date :||October 15, 2019|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2027|
Active Comparator: extended lymph node dissection
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.
Procedure: lymph node dissection
At least 10 lymph nodes must be removed.
No Intervention: standard without lymph node dissection
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).
- 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).
- Incidence of lymphoceles and complications [ Time Frame: 6 months after surgery ](Clavien classification)
- quality of life including continence and potency [ Time Frame: 6, 12, 24, 36 months after surgery ]Questionnaire Expanded prostate cancer index composite (EPIC-26)
- metastasis-free survival [ Time Frame: 36 months ]diagnosis of metastasis after prostatectomy by radiological assessment
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||Prostate Cancer|
|Accepts Healthy Volunteers:||No|
- 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
- American Society of Anesthesiology Classification> 3
- Existing contraindications for performing a lymph node dissection
- Neoadjuvant hormone therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04269512
|Contact: Markus Graefen, Prof.||+49 (0)40 7410 email@example.com|
|Contact: Jonas Ekrutt, Dr.||+49 (0)40 7410 firstname.lastname@example.org|
|Martini-Klinik am UKE GmbH||Recruiting|
|Hamburg, Germany, 20246|
|Contact: Markus Graefen, Professor +4904741051300 email@example.com|
|Contact: Anke Renter +49047410533115 firstname.lastname@example.org|
|Principal Investigator:||Markus Graefen||Director|
|Responsible Party:||Martini-Klinik am UKE GmbH|
|Other Study ID Numbers:||
|First Posted:||February 13, 2020 Key Record Dates|
|Last Update Posted:||October 28, 2021|
|Last Verified:||October 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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