Prostate Cancer RecurrentNCT02974075
Salvage Lymph Node Dissection in Prostate Cancer Patients With Recurrence After Radical Prostatectomy
A study testing Salvage lymph node dissection in people with Prostate Cancer Recurrent, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer Recurrent
- What is being tested?
- Salvage lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2016to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Prostate Cancer Recurrent
- Being tested
- Salvage lymph node dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salvage lymph node dissectionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Salvage lymph node dissection | Experimental | Patients will undergo extended pelvic salvage lymph node dissection Receives: Procedure: Salvage lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of periperative complications within 90 days after surgery
Measured: 90 days
The Prostate specific antigen value after 6 weeks.
Measured: 6 weeks
Secondary outcomes (3)
Change in Prostate Specific Antigen doubling time
Measured: 2 years
Time until development of castration resistance
Measured: 2 years
Time until development of distant metastasis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2022
- Study completionNov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Bernhard Grubmüller, Medical University of Vienna
- Investigators
- Shahrokh Francois Shariat, MD, Study chair, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974075
- Sponsor's protocol ID
- 1460/2016
- Status last verified
- May 2025
- First submitted
- 20 Nov 2016
- Last updated
- 14 May 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02974075
- Acronym / sponsor ID
- 1460/2016
- Conditions
- Prostate Cancer Recurrent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Nov 2022 (actual)
- Study completion
- Nov 2024 (actual)
- First posted
- 28 Nov 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Salvage lymph node dissection | Experimental | Procedure: Salvage lymph node dissectionPatients will undergo extended pelvic salvage lymph node dissection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Salvage lymph node dissectionOpen 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 | Procedure or surgery | Salvage lymph node dissection |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
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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.
Shahrokh Francois Shariat, MD study chair
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salvage lymph node dissection in people with Prostate Cancer Recurrent, run by Medical University of Vienna at 1 site in Austria.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 14 May 2025. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The rate of periperative complications within 90 days after surgery (time frame: 90 days). The study lists 2 primary outcomes in all. 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 14 May 2025.