Prostate Cancer RecurrentBioPoPNCT04324983
Identification of Predictive Biomarkers
A study testing Blood sample in people with Prostate Cancer Recurrent, run by Martini-Klinik am UKE GmbH at 1 site in Germany.
Trial summary
Molecular nuclear imaging in prostate cancer has made significant progress in the last few years. The introduction of tracers that target the prostate-specific membrane antigen (PSMA) has profoundly influenced imaging diagnostics in prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer Recurrent
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2020to 5 Apr 2023
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in good general health and an expected life expectancy of > 10 years
- Diagnosis of prostate cancer relapse
- Evidence of positive lymph nodes or soft tissue metastases as seen in PSMA PET
Who cannot join
- Contraindication for a surgical procedure
- Clinical suspicion of systemic disease as determined by PSMA PET
- PSMA PET examination older than 4 months at time of surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Predictive Biomarkers for Successful Salvage Surgeries on PSMA-PET-positive Limited Metastatic Prostate Cancer Relapses
Molecular nuclear imaging in prostate cancer has made significant progress in the last few years. The introduction of tracers that target the prostate-specific membrane antigen (PSMA) has profoundly influenced imaging diagnostics in prostate cancer. In case of relapse after curative treatment (especially after radical prostatectomy), PSMA positron emission tomography (PET) has the ability to detect lesions already at very low prostate-specific antigen (PSA) levels. The improved detection of relapses increases the interest of individualized targeted therapies in patients with prostate cancer recurrence. Thus, this development led to the acceptance of PSMA PET for diagnostics in prostate cancer patients with biochemical relapses in national and international guidelines.
Read the detailed description
As mentioned before, current data on salvage lymphadenectomy in prostate cancer is very limited and stems mainly from retrospective series. Prospective studies are not available. Furthermore, most of these analyses are based on choline-based positron emission tomography, which by now has been progressively replaced with the significantly more sensitive and specific PSMA-based PET. Diagnostic advantages are especially obvious in early biochemical recurrence with low PSA levels . The high specificity of a PSMA Tracer in diagnosing prostate cancer tissue is further demonstrated by the introduction of PSMA-radioguided surgery. Here, patients are injected intravenously before surgery with 111In- or 99mTc-labeled PSMA ligands in order to enhance intraoperative detection of affected lymph nodes that show radiotracer accumulation.
Regarding biomarkers used in prostate cancer, besides PSA and PSA-associated variations, there also exists a multiple number of different biomarkers. However, most of these biomarkers are used in the primary diagnostic setting or in advanced metastatic tumor stages with a castration-resistant stage. However, especially in early biochemical recurrences there is a need for biomarkers to help determine whether or not local salvage treatment can or should be considered. Circulating tumor cells (CTCs) are promising candidates as a biomarker, that could support the decision-making process. While the prognostic relevance of CTCs for patients with a metastatic castration-resistant stage prostate cancer has been shown in many studies, far less data exists for patients with hormone-sensitive metastatic prostate cancer. Regardless of the fact, survival is associated with the number of CTCs measured in peripheral blood. Recently, we were able to show that CTCs in patients with limited metastatic prostate cancer exhibited higher prognostic relevance, before and after cytoreductive radical prostatectomy, than conventional biomarkers (PSA, LDH =lactate Dehydrogenase and BAP). Even when the conventional biomarkers were combined with routine markers and CTCs, the prognostic relevance did not increase. Although the case numbers were very small, in the future, CTCs could still help identify patients that would most profit from a cytoreductive radical prostatectomy.
Therefore, this project will investigate whether or not CTCs can preoperatively provide prognostic information on the postoperative oncological response, as described in the study protocol. The plan is to withdraw blood (7,5 ml) before surgery from 150 limited metastatic prostate cancer patients. These patients have to qualify for salvage surgery according to the PSMA-PET. The blood will be examined with the Cell-Search-Systems for CTCs and their PSMA Expression.
Plasma samples and peripheral blood mononuclear cells (PBMCs) from peripheral blood will also be stored. These samples will be used later for a further project on prostate cancer-specific exosomes where PSMA positivity and cell-free circulating nucleic acids will be examined. The expertise for such analyses, standard operating procedures (SOPs) and necessary equipment are available.
Furthermore, the Institute for Tumor Biology has recently established a new blood test for detecting breast cancer. This test will also be used on prostate cancer patients within the scope of this project. This test measures the serum concentration of Cyr61-Proteins. The Institute has established an Enzyme-Linked Immunosorbent Assay (ELISA), which has already been successfully implemented for the analysis of blood plasma in 527 breast cancer patients. Consequently, this newly developed blood test presents an important improvement in the diagnosis of breast cancer (International patent System 2018/054052). It would also like to test this method for its adequacy and improvement in the diagnosis of prostate cancer within the context of this project.
Furthermore, in a subset of patients additionally tissue from metastatic lymph nodes will be collected for molecularpathologic analysis if tissue sampling does not affect routine pathological examination.
- Conditions
- Prostate Cancer Recurrent
- Being tested
- Blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Additional blood sample of about 30 ml that will be drawn for biomarker analyses (2 EDTA = ethylenediaminetetraacetic acid and 1 Cell-search-tubes).The drawn blood for CTC-Analysis and biomarker identification will be promptly processed ac-cording to the established standards at the Institute for Tumor Biology (see below).
The histological analysis of the resected tissue during salvage surgery is carried out according to clinical routine (conventional haematoxylin and eosin stained and PSMA-Immunohistochemistry). Additionally, tissue samples will undergo molecularpathological analysis if this does not affect routine pathological examination.
| Study group | Role | What they receive |
|---|---|---|
| Biomarker | Other | This single-arm study is a Phase I study to exploratively identify potential biomarkers in patients with early prostate cancer relapse and limited metastases in PSMA-PET, who need further assistance in treatment decisions (for or against local treatment options). Receives: Other: Blood sample |
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)
PSA Level after salvage lymphadenectomy without adjuvant prostate cancer-specific treatment
Measured: 6 months
Secondary outcomes (2)
Prostate cancer-specific treatment-free survival after salvage surgery
PSA-Level after salvage lymphadenectomy
Measured: 3, 6, 12 and 24 months
Questionnaire Quality of life
Expanded prostate cancer index Composite (EPIC 26)
Measured: 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Mar 2020
- Primary completion5 Apr 2023
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer RecurrentStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In this single-arm prospective clinical study, various blood- and serum-based biomarkers, from patients with early PSMA PET positive limited metastatic prostate cancer relapse after radical prostatectomy, will be examined according to their potential predictive significance for a successful salvage surgery. Results from the various biomarker values, after salvage surgery, with following clinical endpoints will be assessed: 1. postoperative complete biochemical response (cBR: PSA \<0,2ng/ml) 2. biochemical relapse-free without further prostate cancer specific treatment (time from salvage surgery to first PSA level \>0,2ng/ml) 3. prostate cancer specific treatment-free interval (time from salvage surgery to initiation of a prostate cancer specific treatment)
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martini-Klinik am UKE GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Erich und Gertrud Roggenbuck-Stiftung zur Förderung der Krebsforschung
- Responsible party
- Sponsor
- Investigators
- Tobias Maurer, Prof., Principal investigator, Head Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324983
- Sponsor's protocol ID
- BioPoP-MK-2020-2
- Acronym
- BioPoP
- Status last verified
- Apr 2023
- First submitted
- 3 Mar 2020
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Riethdorf S, Knipper S, Falkenbach F, Coith C, Tilki D, Graefen M, Werner S, Pantel K, Maurer T. Identification of Biomarkers Predictive of Successful Salvage Surgery in Prostate-specific Membrane Antigen Positron Emission Tomography-positive Oligorecurrent Prostate Cancer: Results from the BioPoP Trial. Eur Urol Focus. 2026 Feb 27:S2405-4569(25)00292-5. doi: 10.1016/j.euf.2025.10.006. Online ahead of print.
PubMed 41763960
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Predictive Biomarkers for Successful Salvage Surgeries on PSMA-PET-positive Limited Metastatic Prostate Cancer Relapses
- ClinicalTrials.gov ID
- NCT04324983
- Acronym / sponsor ID
- BioPoP / BioPoP-MK-2020-2
- Conditions
- Prostate Cancer Recurrent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Martini-Klinik am UKE GmbHUniversity, hospital or other
- Collaborators
- Erich und Gertrud Roggenbuck-Stiftung zur Förderung der Krebsforschung
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 27 Mar 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.
Molecular nuclear imaging in prostate cancer has made significant progress in the last few years. The introduction of tracers that target the prostate-specific membrane antigen (PSMA) has profoundly influenced imaging diagnostics in prostate cancer. In case of relapse after curative treatment (especially after radical prostatectomy), PSMA positron emission tomography (PET) has the ability to detect lesions already at very low prostate-specific antigen (PSA) levels. The improved detection of relapses increases the interest of individualized targeted therapies in patients with prostate cancer recurrence. Thus, this development led to the acceptance of PSMA PET for diagnostics in prostate cancer patients with biochemical relapses in national and international guidelines.
Detailed description
As mentioned before, current data on salvage lymphadenectomy in prostate cancer is very limited and stems mainly from retrospective series. Prospective studies are not available. Furthermore, most of these analyses are based on choline-based positron emission tomography, which by now has been progressively replaced with the significantly more sensitive and specific PSMA-based PET. Diagnostic advantages are especially obvious in early biochemical recurrence with low PSA levels . The high specificity of a PSMA Tracer in diagnosing prostate cancer tissue is further demonstrated by the introduction of PSMA-radioguided surgery. Here, patients are injected intravenously before surgery with 111In- or 99mTc-labeled PSMA ligands in order to enhance intraoperative detection of affected lymph nodes that show radiotracer accumulation.
Regarding biomarkers used in prostate cancer, besides PSA and PSA-associated variations, there also exists a multiple number of different biomarkers. However, most of these biomarkers are used in the primary diagnostic setting or in advanced metastatic tumor stages with a castration-resistant stage. However, especially in early biochemical recurrences there is a need for biomarkers to help determine whether or not local salvage treatment can or should be considered. Circulating tumor cells (CTCs) are promising candidates as a biomarker, that could support the decision-making process. While the prognostic relevance of CTCs for patients with a metastatic castration-resistant stage prostate cancer has been shown in many studies, far less data exists for patients with hormone-sensitive metastatic prostate cancer. Regardless of the fact, survival is associated with the number of CTCs measured in peripheral blood. Recently, we were able to show that CTCs in patients with limited metastatic prostate cancer exhibited higher prognostic relevance, before and after cytoreductive radical prostatectomy, than conventional biomarkers (PSA, LDH =lactate Dehydrogenase and BAP). Even when the conventional biomarkers were combined with routine markers and CTCs, the prognostic relevance did not increase. Although the case numbers were very small, in the future, CTCs could still help identify patients that would most profit from a cytoreductive radical prostatectomy.
Therefore, this project will investigate whether or not CTCs can preoperatively provide prognostic information on the postoperative oncological response, as described in the study protocol. The plan is to withdraw blood (7,5 ml) before surgery from 150 limited metastatic prostate cancer patients. These patients have to qualify for salvage surgery according to the PSMA-PET. The blood will be examined with the Cell-Search-Systems for CTCs and their PSMA Expression.
Plasma samples and peripheral blood mononuclear cells (PBMCs) from peripheral blood will also be stored. These samples will be used later for a further project on prostate cancer-specific exosomes where PSMA positivity and cell-free circulating nucleic acids will be examined. The expertise for such analyses, standard operating procedures (SOPs) and necessary equipment are available.
Furthermore, the Institute for Tumor Biology has recently established a new blood test for detecting breast cancer. This test will also be used on prostate cancer patients within the scope of this project. This test measures the serum concentration of Cyr61-Proteins. The Institute has established an Enzyme-Linked Immunosorbent Assay (ELISA), which has already been successfully implemented for the analysis of blood plasma in 527 breast cancer patients. Consequently, this newly developed blood test presents an important improvement in the diagnosis of breast cancer (International patent System 2018/054052). It would also like to test this method for its adequacy and improvement in the diagnosis of prostate cancer within the context of this project.
Furthermore, in a subset of patients additionally tissue from metastatic lymph nodes will be collected for molecularpathologic analysis if tissue sampling does not affect routine pathological examination.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this single-arm prospective clinical study, various blood- and serum-based biomarkers, from patients with early PSMA PET positive limited metastatic prostate cancer relapse after radical prostatectomy, will be examined according to their potential predictive significance for a successful salvage surgery. Results from the various biomarker values, after salvage surgery, with following clinical endpoints will be assessed: 1. postoperative complete biochemical response (cBR: PSA <0,2ng/ml) 2. biochemical relapse-free without further prostate cancer specific treatment (time from salvage surgery to first PSA level >0,2ng/ml) 3. prostate cancer specific treatment-free interval (time from salvage surgery to initiation of a prostate cancer specific treatment)
| Arm | Type | Receives |
|---|---|---|
| Biomarker | Other | Other: Blood sampleThis single-arm study is a Phase I study to exploratively identify potential biomarkers in patients with early prostate cancer relapse and limited metastases in PSMA-PET, who need further assistance in treatment decisions (for or against local treatment options). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients in good general health and an expected life expectancy of > 10 years
- Diagnosis of prostate cancer relapse
- Evidence of positive lymph nodes or soft tissue metastases as seen in PSMA PET
Key exclusion criteria (3 listed)
- Contraindication for a surgical procedure
- Clinical suspicion of systemic disease as determined by PSMA PET
- PSMA PET examination older than 4 months at time of surgery
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 |
|---|---|---|
| Blood sampleAdditional blood sample of about 30 ml that will be drawn for biomarker analyses (2 EDTA = ethylenediaminetetraacetic acid and 1 Cell-search-tubes).The drawn blood for CTC-Analysis and biomarker identification will be promptly processed ac-cording to the established standards at the Institute for Tumor Biology (see below). The histological analysis of the resected tissue during salvage surgery is carried out according to clinical routine (conventional haematoxylin and eosin stained and PSMA-Immunohistochemistry). Additionally, tissue samples will undergo molecularpathological analysis if this does not affect routine pathological examination. | Other | Biomarker |
Primary outcome
Rate of complete biochemical response (cBR: PSA <0,2ng/ml)
Time frame: 6 months
PSA Level after salvage lymphadenectomy without adjuvant prostate cancer-specific treatment
2 secondary outcomes
Prostate cancer-specific treatment-free survival after salvage surgery
Time frame: 3, 6, 12 and 24 months
Questionnaire Quality of life
Time frame: 3, 6, 12 and 24 months
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 12 Apr 2023.
- Derived from this study: PubMed 41763960Riethdorf S, Knipper S, Falkenbach F, Coith C, Tilki D, Graefen M, Werner S, Pantel K, Maurer T. Identification of Biomarkers Predictive of Successful Salvage Surgery in Prostate-specific Membrane Antigen Positron Emission Tomography-positive Oligorecurrent Prostate Cancer: Results from the BioPoP Trial. Eur Urol Focus. 2026 Feb 27:S2405-4569(25)00292-5. doi: 10.1016/j.euf.2025.10.006. Online ahead of print.
- 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. This study is not recruiting at the moment.
Tobias Maurer, Prof. principal investigator
Head Doctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Prostate Cancer Recurrent, 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 3 inclusion and 3 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 12 Apr 2023. 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?
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?
Rate of complete biochemical response (cBR: PSA <0,2ng/ml) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04324983, which also lists 1 linked publication.
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 Apr 2023.