Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors
Recruiting · NCT05974774 · Interventional (participants receive a specific treatment) · Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
View the official record on ClinicalTrials.gov →Interventions studied
cMABiMAB
What this trial is about
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.
Who can take part
Age range
18 Years to 100 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patient treated with ADT and an ARPI for mHNPC for 6-12 months and presenting with a PSA ≤ 0.2 ng/mL Note: Patient may have received docetaxel and radiotherapy of the prostate and metastases Note: Patients with synchronous or metachronous metastases, high volume/risk or low volume/risk who fulfil the criteria can be included.
- Before patient 's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations
Exclusion criteria
- Patients with M1a on modern imaging technique (PET-Choline or -PSMA or Whole Body MRI) for whom radiation therapy and 2-3 years of hormone therapy is planned
- Patients who underwent or will undergo a bilateral orchiectomy
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment for this trial
- Patients who have received a systemic anti-prostate cancer treatment not approved by EMA together with MAB or a radical prostatectomy for M1 disease
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial
Where it is running
9 locations listed.
- Hospital De La Santa Creu I Sant Pau - Barcelona, Spain
- Centre Francois Baclesse - Caen, France
- University Hospitals Copenhagen - Rigshospitalet - Copenhagen, Denmark
- Institut Daniel Hollard - Grenoble, France
- Hospital Universitario San Carlos - Madrid, Spain
- Hospital Universitario Puerta De Hierro - Majadahonda, Spain
- Clinique La Croix Du Sud - Quint-Fonsegrives, France
- CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole - Toulouse, France
- Gustave Roussy - Villejuif, France