Liquid Biopsy-based Detection of Resistance to Targeted Therapy in Prostate Cancer Patients

NCT03601143 | Unknown

• 1 other identifier: HE 7386/1-1
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study will prospectively compare liquid-biopsy based methods for prediction of resistance under androgen-receptor signaling inhibitors. The main goal is to determine the optimal method to determine androgen-receptor variant 7 (AR-V7) status. In addition, the investigators will explore novel other, AR-V7 independent mechanisms of resistance and their predictive value for proper treatment. These are based on further AR splice variants, and on neuroendocrine differentiation of prostate cancer cells.

Conditions

Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Prostate-specific antigen (PSA) decline >=50%

  The optimal liquid biopsy-based test method to predict PSA response under AR-targeted therapy will be determined.

  24 months

Secondary Outcomes (2)

• Clinical progression-free survival

  24 months

• Overall survival

  36 months

Interventions

Blood samples prior to a new line of AR-targeted therapy OTHER

Blood will be drawn at baseline prior to a new line of AR-targeted therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

metastatic castration-resistant prostate cancer patients planned for a new line of therapy with androgen-receptor signaling inhibitors

You may qualify if:

• Histologically confirmed prostate adenocarcinoma
• Castrate serum testosterone \<50ng/ml or \<1.7nmol/l under continued androgen-deprivation therapy or surgical castration
• Progressive disease at study entry in accordance with Prostate Cancer Working Group 3 criteria (PCWG3):
• Biochemical progression: Three consecutive rises in PSA at least one week apart resulting in two 50% increases over the nadir, and a PSA \>1.0 ng/ml as minimal starting value, or
• Radiologic progression: either two or more new bone lesions on bone scan or a new soft tissue lesion using RECIST (Response evaluation criteria in solid tumors).
• Metastatic disease confirmed on computed tomography (CT) or bone scan
• Planned treatment with ARSi (androgen-receptor signaling receptors)
• Written informed consent of the patient

You may not qualify if:

• Persons who are in a dependency or employment relationship with the investigator or sponsor
• Planned additional concurrent anticancer therapy

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Technical University of Munich, Klinikum rechts der Isar, Department of Urology and Institute of Clinical Chemistry

Munich, 81675, Germany

RECRUITING

Related Publications (1)

• Seitz AK, Thoene S, Bietenbeck A, Nawroth R, Tauber R, Thalgott M, Schmid S, Secci R, Retz M, Gschwend JE, Ruland J, Winter C, Heck MM. AR-V7 in Peripheral Whole Blood of Patients with Castration-resistant Prostate Cancer: Association with Treatment-specific Outcome Under Abiraterone and Enzalutamide. Eur Urol. 2017 Nov;72(5):828-834. doi: 10.1016/j.eururo.2017.07.024. Epub 2017 Aug 14.

  PMID: 28818355 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood

Study Officials

• Matthias M Heck, MD

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

• Christof Winter, MD PhD

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias M Heck, MD

CONTACT

+49894140; matthias.heck@tum.de

Christof Winter, MD PhD

CONTACT

+49894140; christof.winter@tum.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 26, 2018
• Study Start: March 1, 2019
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2024
• Last Updated: October 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)