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Salvage Lymph Node Dissection in Prostate Cancer Patients With Recurrence After Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT02974075
Recruitment Status : Recruiting
First Posted : November 28, 2016
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Bernhard Grubmüller, Medical University of Vienna

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. The rate of periperative complications within 90 days after surgery [ Time Frame: 90 days ]
  2. The Prostate specific antigen value after 6 weeks. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Change in Prostate Specific Antigen doubling time [ Time Frame: 2 years ]
  2. Time until development of castration resistance [ Time Frame: 2 years ]
  3. Time until development of distant metastasis [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prostate cancer patients with lymph node metastasis in pelvic imaging
  • Status post radical prostatectomy with curative intent
  • Ability for informed consent
  • No sign for bone or visceral metastasis
  • Male > 18 years
  • ECOG performance status 0 or 1

Exclusion Criteria:

  • Male < 18 years
  • No ability for informed consent
  • Sign for bone or visceral metastasis
  • Deep venous thrombosis or pulmonary embolism within the last 6 months before study screening
  • ECOG performance status 2 or more

Information from the National Library of Medicine

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


Contacts
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Contact: Bernhard Grubmüller, MD 004314040026150 bernhard.grubmueller@meduniwien.ac.at

Locations
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Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Bernhard Grubmüller, MD    004314040026150    bernhard.grubmueller@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Study Chair: Shahrokh Francois Shariat, MD Medical University of Vienna

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Responsible Party: Dr. Bernhard Grubmüller, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02974075     History of Changes
Other Study ID Numbers: 1460/2016
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
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Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes