Prostate CancerProsToneNCT04271579
Early Prostate Cancer Recurrence With PSMA PET Positive Unilateral Pelvic Lesion(s)
A study testing Salvage Lymphnode dissection in people with Prostate Cancer, run by Martini-Klinik am UKE GmbH at 1 site in Germany.
Trial summary
Significant advances in molecular nuclear medicine imaging in prostate cancer have been achieved in recent years. In particular, the introduction of prostate-specific membrane antigen (PSMA) -based tracers has significantly influenced diagnostic imaging of prostate. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Salvage Lymphnode dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 397 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2019to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients in good general condition with life expectancy> 10 years
- Hormone-sensitive prostate cancer recurrence after radical prostatectomy (patients with status post salvage prostatectomy may be included; salvage radiotherapy for prostate fossa and / or pelvic lymph drainage after radical prostatectomy is not an exclusion criterion)
- Unilateral detection of ≤ 3 PSMA PET positive lymph node metastases in the pelvis (up ot origin of the inferior mesenteric artery)
- PSA at the time of PSMA PET imaging <4 ng / ml
Who cannot join
- Contraindication for surgery or bilateral salvage lymph node dissection
- Suspected prostate cancer recurrence in the prostate fossa (local recurrence) or extrapelvic metastasis on PSMA PET imaging
- Date of PSMA PET examination > 4 months prior to salvage lymph node dissection
- Hormone therapy within 6 months prior to study enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Martini-Klinik am UKE GmbH
Hamburg, 20246
Markus Graefen, Professor, +4904741051300, graefen@uke.de
Anke Renter, +49047410533115, a.renter@uke.de
About this study
Official title: Early Prostate Cancer Recurrence With PSMA PET Positive Unilateral Pelvic Lesion(s): is One-sided Salvage Extended Lymph Node Dissection Enough
Significant advances in molecular nuclear medicine imaging in prostate cancer have been achieved in recent years. In particular, the introduction of prostate-specific membrane antigen (PSMA) -based tracers has significantly influenced diagnostic imaging of prostate. If cancer recurs after surgical removal of the prostate, targeted PSMA PET (positron emission tomography) can detect metastases even at very low PSA (prostate-specific Antigen) values. This increasingly allows individualized specific therapy of patients with prostate cancer recurrence. PSMA PET has now been included in national and international guidelines for the diagnosis of patients with biochemical recurrence of prostate cancer.
Especially in patients in good general condition, with potentially longer life expectancy and early localized PSA recurrence, advances in molecular imaging are increasingly turning local therapy concepts into focus. Here both, radiotherapeutic (salvage radiotherapy of the lymphatic drainage) and surgical interventions (salvage lymph node dissection = removal of the pelvic lymph nodes) are offered on an individual basis.
Read more
These regional therapies mainly aim to achieve a delay of further progression of the prostate cancer disease, and thus delay the initiation of palliative, sustained drug therapy. Previous standard or common practice at salvage lymph node dissection is the removal on both sides of the pelvic lymph nodes even if only one-sided suspicious lymph nodes are detected on imaging. Although the complications of salvage lymph node dissection are usually minor and manageable, they can still lead to impaired lymphatic drainage, leg edema, lymphocele formation or other surgical complications.
The aim of the present study is to investigate whether a unilateral pelvic lymph node dissection on the side of conspicuous PSMA PET is sufficient and a dissection on the contralateral side can be dispensed without negatively impacting oncological outcomes and thereby sparing the patient the potential additional complications of a bilateral pelvic lymph node dissection.
Read the detailed description
In this prospective randomized study, patients with early biochemical recurrence after radical prostatectomy and with PSMA-PET positive unilateral pelvic metastatic lesions are assessed as to whether unilateral and bilateral salvage lymph node dissection are oncologically equivalent. For this, the following endpoints will be evaluated:
- complete biochemical response (cBR: PSA <0.2ng /ml) after salvage lymph node dissection
- biochemical freedom from recurrence without further prostate-cancer-specific therapy (time from salvage lymph node dissection to first PSA value> 0.2ng / ml)
- prostate cancer-specific therapy-free time (time from salvage lymph node dissection to initiation of prostate cancer specific therapy) In addition, the diagnostic accuracy of the preoperative PSMA PET, which led to the indication of salvage lymph node dissection, is to be investigated in the context of the study and the standardized one- or two-sided template lymph node dissection. Furthermore, it should be investigated whether there is a reduction of surgery-associated side effects in patients undergoing unilateral salvage lymph node dissection. In addition, quality of life and psychological stress of patients is systematically recorded by means of validated questionnaires. Since salvage lymph node dissection may also be carried out with the help of currently experimental preoperative labeling with PSMA ligands for easier intraoperative localization (PSMA radioguided surgery), a comparison of conventional salvage surgery and the PSMA radioguided surgery is also planned. However, if applied to patients, PSMA radioguided surgery is performed outside of the study protocol and is explicitly not part of the study protocol.
In case there is no complete biochemical response (cBR, PSA <0.2ng / ml) or, after reaching cBR, a further increase in PSA above 0.2ng / ml threshold is observed after salvage lymph node dissection, an attempt should be made to localize recurrence disease using PSMA PET. This should provide indirect information as to whether re-irradiation following salvage lymph node dissection could be a useful approach and should be investigated in future studies. However, PSMA PET is recommended in the study, but is optional and therefore to be performed outside of the study protocol.
Amendment01, Addition to the two-step consent process: First, suitable patients will be offered participation in this prospective study. If the patients consent, randomization will be carried out and the patient will be informed of the result of the randomization (unilateral or bilateral procedure). Patients will then be asked whether they would like to be treated in accordance with the randomization result. If they consent, they will be treated analogously and included in the study cohort. If they do not consent to be treated analogously to the randomization result, they will be treated as part of a study-associated control group and further observed.
- Conditions
- Prostate Cancer
- Being tested
- Salvage Lymphnode dissection
- Keywords
- prostate cancer recurrence, salvage lymph node dissection
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salvage Lymphnode dissectionProcedure or surgery
A salvage lymphnode dissection is performed in all study patients (both arms)using standard surgical techniques (openly or DaVinci).In patients who were randomized to the bilateral pelvic lymphnode dissection group, a salvage lymphadenectomy was also performed on the opposite side with resection of the corresponding fields that were removed on the PSMA-PET positive side (th "Blinding" must be guaranteed during pathological assessment)
| Study group | Role | What they receive |
|---|---|---|
| Unilateral lymphnode dissection | Active comparator | Salvage lymphnode dissection is performed on the PSMA PET positive side, according to template (obturator, iliac external, iliac internal, iliac commun) and possibly including other anatomical pelvic regions Receives: Procedure: Salvage Lymphnode dissection |
| bilateral Lymphnode dissection | Active comparator | In addition, a salvage lymphnode dissection is performed on the opposite side with resection of the corresponding fields, which were taken on the PSMA-PET positive side Receives: Procedure: Salvage Lymphnode dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete biochemical response
cBR: PSA <0.2ng / ml after salvage lymph node dissection without adjuvant prostate cancer specific therapy
Measured: 24 months
Secondary outcomes (1)
Prostate cancer-specific therapy-free survival
e.g. medicinal, radiotherapy, operative
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start15 Oct 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 397 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martini-Klinik am UKE GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271579
- Sponsor's protocol ID
- ProsTone-MK-2020
- Other IDs
- DRKS00020130
- Acronym
- ProsTone
- Status last verified
- Jan 2026
- First submitted
- 12 Feb 2020
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prostate Cancer Recurrence With PSMA PET Positive Unilateral Pelvic Lesion(s): is One-sided Salvage Extended Lymph Node Dissection Enough
- ClinicalTrials.gov ID
- NCT04271579
- Acronym / sponsor ID
- ProsTone / ProsTone-MK-2020
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer recurrence, salvage lymph node dissection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 397 participants (estimated)
- Lead sponsor
- Martini-Klinik am UKE GmbHUniversity, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Feb 2020 (actual)
- 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.
Significant advances in molecular nuclear medicine imaging in prostate cancer have been achieved in recent years. In particular, the introduction of prostate-specific membrane antigen (PSMA) -based tracers has significantly influenced diagnostic imaging of prostate. If cancer recurs after surgical removal of the prostate, targeted PSMA PET (positron emission tomography) can detect metastases even at very low PSA (prostate-specific Antigen) values. This increasingly allows individualized specific therapy of patients with prostate cancer recurrence. PSMA PET has now been included in national and international guidelines for the diagnosis of patients with biochemical recurrence of prostate cancer.
Especially in patients in good general condition, with potentially longer life expectancy and early localized PSA recurrence, advances in molecular imaging are increasingly turning local therapy concepts into focus. Here both, radiotherapeutic (salvage radiotherapy of the lymphatic drainage) and surgical interventions (salvage lymph node dissection = removal of the pelvic lymph nodes) are offered on an individual basis.
These regional therapies mainly aim to achieve a delay of further progression of the prostate cancer disease, and thus delay the initiation of palliative, sustained drug therapy. Previous standard or common practice at salvage lymph node dissection is the removal on both sides of the pelvic lymph nodes even if only one-sided suspicious lymph nodes are detected on imaging. Although the complications of salvage lymph node dissection are usually minor and manageable, they can still lead to impaired lymphatic drainage, leg edema, lymphocele formation or other surgical complications.
The aim of the present study is to investigate whether a unilateral pelvic lymph node dissection on the side of conspicuous PSMA PET is sufficient and a dissection on the contralateral side can be dispensed without negatively impacting oncological outcomes and thereby sparing the patient the potential additional complications of a bilateral pelvic lymph node dissection.
Detailed description
In this prospective randomized study, patients with early biochemical recurrence after radical prostatectomy and with PSMA-PET positive unilateral pelvic metastatic lesions are assessed as to whether unilateral and bilateral salvage lymph node dissection are oncologically equivalent. For this, the following endpoints will be evaluated:
- complete biochemical response (cBR: PSA <0.2ng /ml) after salvage lymph node dissection
- biochemical freedom from recurrence without further prostate-cancer-specific therapy (time from salvage lymph node dissection to first PSA value> 0.2ng / ml)
- prostate cancer-specific therapy-free time (time from salvage lymph node dissection to initiation of prostate cancer specific therapy) In addition, the diagnostic accuracy of the preoperative PSMA PET, which led to the indication of salvage lymph node dissection, is to be investigated in the context of the study and the standardized one- or two-sided template lymph node dissection. Furthermore, it should be investigated whether there is a reduction of surgery-associated side effects in patients undergoing unilateral salvage lymph node dissection. In addition, quality of life and psychological stress of patients is systematically recorded by means of validated questionnaires. Since salvage lymph node dissection may also be carried out with the help of currently experimental preoperative labeling with PSMA ligands for easier intraoperative localization (PSMA radioguided surgery), a comparison of conventional salvage surgery and the PSMA radioguided surgery is also planned. However, if applied to patients, PSMA radioguided surgery is performed outside of the study protocol and is explicitly not part of the study protocol.
In case there is no complete biochemical response (cBR, PSA <0.2ng / ml) or, after reaching cBR, a further increase in PSA above 0.2ng / ml threshold is observed after salvage lymph node dissection, an attempt should be made to localize recurrence disease using PSMA PET. This should provide indirect information as to whether re-irradiation following salvage lymph node dissection could be a useful approach and should be investigated in future studies. However, PSMA PET is recommended in the study, but is optional and therefore to be performed outside of the study protocol.
Amendment01, Addition to the two-step consent process: First, suitable patients will be offered participation in this prospective study. If the patients consent, randomization will be carried out and the patient will be informed of the result of the randomization (unilateral or bilateral procedure). Patients will then be asked whether they would like to be treated in accordance with the randomization result. If they consent, they will be treated analogously and included in the study cohort. If they do not consent to be treated analogously to the randomization result, they will be treated as part of a study-associated control group and further observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral lymphnode dissection | Active comparator | Procedure: Salvage Lymphnode dissectionSalvage lymphnode dissection is performed on the PSMA PET positive side, according to template (obturator, iliac external, iliac internal, iliac commun) and possibly including other anatomical pelvic regions |
| bilateral Lymphnode dissection | Active comparator | Procedure: Salvage Lymphnode dissectionIn addition, a salvage lymphnode dissection is performed on the opposite side with resection of the corresponding fields, which were taken on the PSMA-PET positive side |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients in good general condition with life expectancy> 10 years
- Hormone-sensitive prostate cancer recurrence after radical prostatectomy (patients with status post salvage prostatectomy may be included; salvage radiotherapy for prostate fossa and / or pelvic lymph drainage after radical prostatectomy is not an exclusion criterion)
- Unilateral detection of ≤ 3 PSMA PET positive lymph node metastases in the pelvis (up ot origin of the inferior mesenteric artery)
- PSA at the time of PSMA PET imaging <4 ng / ml
Key exclusion criteria (4 listed)
- Contraindication for surgery or bilateral salvage lymph node dissection
- Suspected prostate cancer recurrence in the prostate fossa (local recurrence) or extrapelvic metastasis on PSMA PET imaging
- Date of PSMA PET examination > 4 months prior to salvage lymph node dissection
- Hormone therapy within 6 months prior to study enrollment
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 Lymphnode dissectionA salvage lymphnode dissection is performed in all study patients (both arms)using standard surgical techniques (openly or DaVinci).In patients who were randomized to the bilateral pelvic lymphnode dissection group, a salvage lymphadenectomy was also performed on the opposite side with resection of the corresponding fields that were removed on the PSMA-PET positive side (th "Blinding" must be guaranteed during pathological assessment) | Procedure or surgery | Unilateral lymphnode dissection, bilateral Lymphnode dissection |
Primary outcome
Rate of complete biochemical response
Time frame: 24 months
cBR: PSA <0.2ng / ml after salvage lymph node dissection without adjuvant prostate cancer specific therapy
1 secondary outcome
Prostate cancer-specific therapy-free survival
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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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.
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 Lymphnode dissection in people with Prostate Cancer, run by Martini-Klinik am UKE GmbH at 1 site in Germany.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 12 Jan 2026. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tobias Maurer, PD Dr. (+49 (0) 40 7410 53115, t.maurer@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complete biochemical response (time frame: 24 months). 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 12 Jan 2026.