Identification of Predictive Biomarkers

NCT04324983 | Completed

• 1 other identifier: BioPoP-MK-2020-2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostate Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

• Rate of complete biochemical response (cBR: PSA <0,2ng/ml)

  PSA Level after salvage lymphadenectomy without adjuvant prostate cancer-specific treatment

  6 months

Secondary Outcomes (2)

• Prostate cancer-specific treatment-free survival after salvage surgery

  3, 6, 12 and 24 months

• Questionnaire Quality of life

  3, 6, 12 and 24 months

Study Arms (1)

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).

Other: Blood sample

Interventions

Blood sample OTHER

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.

Biomarker

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Martini-Klinik am UKE GmbH: lead
• Erich und Gertrud Roggenbuck-Stiftung zur Förderung der Krebsforschung: collaborator

Study Sites (1)

Martini-Klinik am UKE GmbH

Hamburg, 20246, Germany

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Tobias Maurer, Prof.

  Head Doctor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 27, 2020
• Study Start: March 1, 2020
• Primary Completion: April 5, 2023
• Study Completion: April 5, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)