Prostate Androgen Response Investigation using a Stratification BIOmarker - PARIS-BIO Predicting prostate cancer downstageing by neoadjuvant Darolutamide with PCAI ImmunoScore in a non-randomised open label prospective trial.

Conditions

High-risk localized or locally advanced prostate adenocarcinoma

Brief summary

Association of pathological response (MRD) with the pre-treatment genomic biomarker PCAI ImmunoScore

Detailed description

The associaton of the PCAI ImmunoScore with pathologic complete response (pCR), The associaton of the PCAI ImmunoScore with pT-stage at final pathology, The associaton of the PCAI ImmunoScore with size of largest cross-sectional dimension of residual tumour on pathology, The associaton of the PCAI ImmunoScore with number of resection specimen slides in which the tumour can be seen on pathology, The associaton of the PCAI ImmunoScore with MRI assessment of changes in tumour size, cross sectional dimension, volume, and EPE, The associaton of the PCAI ImmunoScore with blood PSA concentration during treatment, Correlation between Pathological response and MRI response., Hormonal side effects during and after treatment, measured through AE/SAE registration and repeated validated questionnaires as well as changes in blood testosterone concentration, Post- surgical functional outcomes (erectile function and urinary continence) in the cohort measured through questionnaires

Related papers

No related papers found yet.

Interventions

DRUGNUBEQA 300 mg film-coated tablets

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Association of pathological response (MRD) with the pre-treatment genomic biomarker PCAI ImmunoScore	—

Secondary

Measure	Time frame
The associaton of the PCAI ImmunoScore with pathologic complete response (pCR), The associaton of the PCAI ImmunoScore with pT-stage at final pathology, The associaton of the PCAI ImmunoScore with size of largest cross-sectional dimension of residual tumour on pathology, The associaton of the PCAI ImmunoScore with number of resection specimen slides in which the tumour can be seen on pathology, The associaton of the PCAI ImmunoScore with MRI assessment of changes in tumour size, cross sectional dimension, volume, and EPE, The associaton of the PCAI ImmunoScore with blood PSA concentration during treatment, Correlation between Pathological response and MRI response., Hormonal side effects during and after treatment, measured through AE/SAE registration and repeated validated questionnaires as well as changes in blood testosterone concentration, Post- surgical functional outcomes (erectile function and urinary continence) in the cohort measured through questionnaires	—

Measure

Time frame

The associaton of the PCAI ImmunoScore with pathologic complete response (pCR), The associaton of the PCAI ImmunoScore with pT-stage at final pathology, The associaton of the PCAI ImmunoScore with size of largest cross-sectional dimension of residual tumour on pathology, The associaton of the PCAI ImmunoScore with number of resection specimen slides in which the tumour can be seen on pathology, The associaton of the PCAI ImmunoScore with MRI assessment of changes in tumour size, cross sectional dimension, volume, and EPE, The associaton of the PCAI ImmunoScore with blood PSA concentration during treatment, Correlation between Pathological response and MRI response., Hormonal side effects during and after treatment, measured through AE/SAE registration and repeated validated questionnaires as well as changes in blood testosterone concentration, Post- surgical functional outcomes (erectile function and urinary continence) in the cohort measured through questionnaires

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Countries

Sweden

Outcome results

None listed