Salvage Lymph Node Dissection in Prostate Cancer Patients With Recurrence After Radical Prostatectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02974075|
Recruitment Status : Recruiting
First Posted : November 28, 2016
Last Update Posted : March 21, 2018
Despite continuous technical improvements in urologic surgery, up to 40% of prostate cancer patients will develop biochemical recurrence after radical prostatectomy (RP), potentially because of micro metastasis at the time of the primary surgery.
With improved radiological modalities and nuclear medicine tracers like 68Ga-PSMA PET/CT, which allow the localization of the site of recurrence, there is increasing interest in metastasis directed therapies, such as salvage lymph node dissection.
The pelvic extended salvage lymph node dissection (sLND) is a promising option for treating prostate cancer patients with local recurrence after radical prostatectomy with curative intent. Several retrospective series has been published to determine the local value of sLND. Despite the first data seem to be feasible and promising, to date no prospective evaluation has been made. Thus sLND is still experimental according to the guidelines and is considered as an off label therapy.
This prospective single center phase I/II study was conducted to investigate the safety and early efficacy of salvage lymph node dissection in prostate cancer patients with local pelvic recurrence after radical prostatectomy (RP) with curative intention.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Recurrent||Procedure: Salvage lymph node dissection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Salvage Lymph Node Dissection in Prostate Cancer Patients With Nodal Recurrence After Radical Prostatectomy With Curative Intent - a Prospective Single Center Phase I/II Study|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2023|
Experimental: Salvage lymph node dissection
Patients will undergo extended pelvic salvage lymph node dissection
Procedure: Salvage lymph node dissection
Open pelvic surgery to dissect pelvic lymph nodes. The landmarks for dissection are: 1. Inferior mesenteric artery 2. Ilioinguinal nerve 3. Inguinal ligament 4. Dorsal pelvic floor 5. Urinary bladder
- The rate of periperative complications within 90 days after surgery [ Time Frame: 90 days ]
- The Prostate specific antigen value after 6 weeks. [ Time Frame: 6 weeks ]
- Change in Prostate Specific Antigen doubling time [ Time Frame: 2 years ]
- Time until development of castration resistance [ Time Frame: 2 years ]
- Time until development of distant metastasis [ Time Frame: 2 years ]
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): NCT02974075
|Contact: Bernhard Grubmüller, MDemail@example.com|
|Medical University of Vienna||Recruiting|
|Vienna, Austria, 1090|
|Contact: Bernhard Grubmüller, MD 004314040026150 firstname.lastname@example.org|
|Study Chair:||Shahrokh Francois Shariat, MD||Medical University of Vienna|