Individualisation of management with novel upfront therapies in newly diagnosed metastasized prostate cancer using (PSMA)PET/CT imaging

Recruiting

Conditions: Prostate cancer
Malignancy of the prostate
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Registration Number: NL-OMON51925

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

- Men >18 years of age.
- Mentally competent and understanding of benefits and potential burden of the
study.
- Written and signed informed consent.
- Histological confirmed diagnosis of adenocarcinoma of the prostate.
- Indicated to start on hormonal therapy (any LHRH agonist or antagonist).
- Indicated to start on upfront ARTA therapy (i.e. abiraterone or apalutamide).
- Any initial PSA.
- Any Gleason score.
- Any T-stage.
- Any N-stage.
- Stage M1 (any; M1a, M1b, and/or M1c).
- More than three (>3) metastatic lesions (any combination of either lymph node
metastasis outside of pelvis, bone metastasis, or visceral metastasis), as seen
on imaging (any combination of CT, MRI, skeletal scintigraphy, and/or
(PSMA-)PET/CT-imaging).

Exclusion Criteria

- Concomitant malignancy (except from BCC of the skin).
- History of prior diagnosed or treated PCa.
- Any unrelated illness (e.g. active infection, inflammation or laboratory
abnormalities) that in the judgment of the investigator will significantly
affect patient*s clinical status.
- Any known allergy for the upfront therapy.
- Any known allergy for LHRH agonist.
- Starting on other upfront combination therapy than abiraterone or
apalutamide.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary parameter: Predictive value of early response on PSMA-PET/CT to upfront<br /><br>therapy, according to PERCIST criteria. Primary endpoint: Time to development<br /><br>of CRPC.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters: Predictive value of early response on PSMA-PET/CT to<br /><br>hormonal therapy; predictive value of baseline PSMA-PET/CT, analysis of<br /><br>response in different subgroups of patients: e.g. high versus low tumour load,<br /><br>high versus low PSA, high versus low Gleason score. Secondary endpoint: Time to<br /><br>initiation of second line therapy after castration-resistant disease has been<br /><br>found. </p><br>