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.
Full Title of Study: “Prospective Randomized Trial to Evaluate the Prognostic Role of Lymphnode Dissection in Men With Prostate Cancer Treated With Radical Prostatectomy (Predict-Study)”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: October 2022
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.
- Procedure: lymph node dissection
- At least 10 lymph nodes must be removed.
Arms, Groups and Cohorts
- 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.
- 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).
Clinical Trial Outcome Measures
- 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
Participating in This Clinical Trial
- 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
Gender Eligibility: Male
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Martini-Klinik am UKE GmbH
- Provider of Information About this Clinical Study
- Overall Official(s)
- Markus Graefen, Principal Investigator, Director
- Overall Contact(s)
- Markus Graefen, Prof., +49 (0)40 7410 53115, firstname.lastname@example.org
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