Quantification of Circulating tumor DNA derived Structural variants to assess treatment response in metastatic prostate cancer patients

Quantification of Circulating tumor DNA derived Structural variants to assess treatment response in metastatic prostate cancer patients - Circus study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43524

Enrollment

285

Registered

2016-03-08

Start date

2016-04-21

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

prostate cancer prostate carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - metastasized castration resistant prostate cancer - participation in CPCT-02 study - age * 18 years - written informed consent

Exclusion criteria

Exclusion criteria: - not meeting the inclusion criteria

Design outcomes

Secondary

Measure	Time frame
Secondary, exploratory endpoints include the overlap in SVs between tumor biopsy samples pre- and post-treatment, the longitudinal assessment of SV load under influence of systemic treatment and the interval between detected variations in SV load PSA response and imaging modality markers.	—

Primary

Measure	Time frame
The primary endpoint is the rate of mPC patients with quantifiable tumor-specific SVs in ctDNA from plasma taken pre-treatment; quantifiable is: the number of SV copies per milliliter plasma (load) is above the lower limit of detection (LLD).	—

Countries

Netherlands

Outcome results