To assess the predictive value of early response measurements on PSMA-PET/CT for therapy success, defined as time to development of castration-resistant prostate cancer (CRPC), in order to personalize treatment choice.
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
- Genitourinary tract disorders NEC
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary parameter: Predictive value of early response on PSMA-PET/CT to upfront
therapy, according to PERCIST criteria. Primary endpoint: Time to development
of CRPC.
Secondary outcome
Secondary parameters: Predictive value of early response on PSMA-PET/CT to
hormonal therapy; predictive value of baseline PSMA-PET/CT, analysis of
response in different subgroups of patients: e.g. high versus low tumour load,
high versus low PSA, high versus low Gleason score. Secondary endpoint: Time to
initiation of second line therapy after castration-resistant disease has been
found.
Background summary
Men, newly diagnosed with metastasized prostate cancer, who start on standard
hormonal therapy, are additionally treated with either upfront chemotherapy or
upfront extra androgen-receptor targeted agents (*ARTA*), as per guidelines*
recommendations. The benefit in overall survival of these two options is
similar, but important differences exist in patient-specific efficacy, costs,
side-effects, and impact on quality of life. No predictive factors are
available to individualize treatment choice. Currently, a one-size-fits-all
strategy with hormonal therapy plus chemotherapy is usually followed.
Study objective
To assess the predictive value of early response measurements on PSMA-PET/CT
for therapy success, defined as time to development of castration-resistant
prostate cancer (CRPC), in order to personalize treatment choice.
Study design
Prospective, single arm, open label, non-interventional, non-therapeutic
observational cohort study.
Study burden and risks
Patients will be treated according to standard of care using hormonal therapy
and ARTA, including baseline diagnostic PSMA-PET/CT. The timing of follow-up
PSMA-PET/CT imaging however will be standardized, instead of at biochemical or
clinical signs of disease progression: One PSMA-PET/CT will be performed after
2 months of hormonal therapy, one PSMA-PET/CT will be performed after 2 months
of upfront therapy. Each PSMA-PET/CT scan will require: an extra visit (2-3
hours) and a limited radiation burden after intravenous injection of PSMA. The
additional information from the standardized follow-up PSMA-PET/CT scans will
not be used for clinical decision making.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77093.041.21 |