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
- Miscellaneous and site unspecified neoplasms benign
- 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 parameter: Predictive value of baseline PSMA-PET/CT imaging on time
to development of CRPC, Predictive value of early response to ADT only on time
to development of CRPC, Predictive value of early response to ADT combined with
upfront therapy on time to development of CRPC, Analysis of response in
different subgroups of patients: e.g. high versus low tumour load, high versus
low PSA, high versus low Gleason score, low versus high age
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 on PSMA PET/CT, 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 enzalutamide, including baseline diagnostic PSMA-PET/CT. The timing of
follow-up PSMA-PET/CT imaging will be standardized. Instead of imaging at
biochemical or clinical signs of disease progression, one PSMA-PET/CT will be
performed after two months of hormonal therapy, one PSMA-PET/CT will be
performed after two 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 enzalutamide therapy
- Any initial PSA.
- Any Gleason score.
- Any T-stage.
- Any N-stage.
- Stage M1, with multiple / high volume metastasis: more than three (>3)
metastatic lesions (any combination of either lymph node metastasis outside of
pelvis, bone metastasis, or visceral metastasis), as seen on
PSMA-PET/CT-imaging. As these patients are treated with palliative intent.
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 and/or outcome of the study.
- Any known allergy for the upfront therapy.
- Any known allergy for LHRH agonist or antagonist.
- Starting on other hormonal therapy than LHRH agonist or antagonist (max 4
weeks of androgen blockade (e.g. bicalutamide) is allowed to prevent flare
phenomenon with LHRH agonist).
- Starting on other upfront combination therapy than enzalutamide.
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT05539300 |
| CCMO | NL81959.041.22 |