At a glance
ClinicalIndex Comparison Record- ✓Patient treated with ADT and an ARPI for mHNPC for 6-12 months with PSA ≤ 0.2 ng/mL
- ✓May have received docetaxel and radiotherapy of prostate and metastases
- ✓Patients with synchronous or metachronous metastases of any volume/risk category
- ✓Written informed consent required per ICH/GCP and national/local regulations
- ✕M1a disease on modern imaging planned for radiation therapy and 2-3 years hormone therapy
- ✕Prior or planned bilateral orchiectomy
- ✕Prior or concurrent malignancy with potential to interfere with safety or efficacy assessment
- ✕Received unapproved systemic anti-prostate cancer treatment with MAB or radical prostatectomy for M1 disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors; a Phase 3 Pragmatic Randomized Trial.
In Brief
A Phase 3 clinical trial evaluating iMAB and cMAB for Prostate Cancer. Currently recruiting, targeting 1,600 participants across 9 sites in 3 countries.
Signals
Detailed Summary
This study addresses the global topic of treatment optimization, i.e. achieving similar benefit while reducing the duration of treatment, hence hoping to decrease the burden of side-effects, improve quality-of life and reduce resource utilization. The primary goal of de-escalation is to investigate whether using an intermittent regime results in a similar OS to continuous treatment.
Study Details
Timeline
Interventions
no treatment until significant PSA increase as per treating physician at which point patient restarts ADT (LHRH agonist or antagonist) + ARPI (abiraterone or enzalutamide or apalutamide or darolutamide). Once PSA \< 0.2 ng/mL, treatment stops again.
LHRH agonist or antagonist + ARPI (abiraterone or enzalutamide or apalutamide or darolutamide)