Identification of predictive Biomarkers for successful salvage surgeries on PSMA-PET-positive oligometastatic Prostate cancer relapses (BioPoP)

Identification of predictive Biomarkers for successful salvage surgeries on PSMA-PET-positive oligometastatic Prostate cancer relapses (BioPoP) - BioPop

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00020820

Enrollment

150

Registered

2020-02-26

Start date

2020-04-08

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C61

Interventions

Group 1: Additional blood sample of about 30 ml that will be drawn for biomarker analyses (2 EDTA- and 1 Cell-search-tubes). If possible, part of the metastatic lymph node tissue is preserved for mole

Eligibility

Sex/Gender

Male

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: • Patients in good general condition with an life expectancy> 10 years • presence of prostate cancer recurrence • Detection of PSMA PET positive lymph node or soft tissue metastases

Exclusion criteria

Exclusion criteria: • Contraindication to surgery • Clinical suspicion of a systemic disease in PSMA PET • Age of the PSMA PET examination > 4 months at the time of surgery

Design outcomes

Primary

Measure	Time frame
Primary correlation of the results from the biomarker measurements with: Rate of complete biochemical response (cBR: PSA <0,2ng/ml) 6 months after salvage lymphadenectomy without adjuvant prostate cancer-specific treatment (e.g. drugs, radiotherapy, surgery)	—

Secondary

Measure	Time frame
Secondary correlation of the results from the biomarker measurements with: • Rate of complete biochemical response (cBR: PSA 0,2ng/ml or PSA relapse postoperative after initial cBR) – analyses of patients who subsequently received a PSMA PET examination • Localization of relapse and the relapse pattern (postoperative PSMA PET shows PSA persistence >0,2ng/ml or PSA relapse postoperativ after initial cBR) – analyses of patients who subsequently received a PSMA PET examination • Quality of life according to EPIC-26, SF-12 and Regret-Questionnaire	—

Measure

Time frame

Secondary correlation of the results from the biomarker measurements with: • Rate of complete biochemical response (cBR: PSA 0,2ng/ml or PSA relapse postoperative after initial cBR) – analyses of patients who subsequently received a PSMA PET examination • Localization of relapse and the relapse pattern (postoperative PSMA PET shows PSA persistence >0,2ng/ml or PSA relapse postoperativ after initial cBR) – analyses of patients who subsequently received a PSMA PET examination • Quality of life according to EPIC-26, SF-12 and Regret-Questionnaire

—

Countries

Germany

Contacts

Public ContactTobias Maurer

Martini-Klinik am UKE GmbH

t.maurer@uke.de040 741053115

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026