Status:
RECRUITING
Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Collaborating Sponsors:
Cancer Trials Ireland
UNICANCER
Conditions:
Prostate Cancer
Eligibility:
MALE
18-100 years
Phase:
PHASE3
Brief 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 q...
Detailed Description
Prostate cancer is known to be dependent on testicular and adrenal androgens and the earliest identified treatments were the suppression of the body's production of testosterone. Then came the develop...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2039
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT05974774
Start Date
May 23 2025
End Date
June 1 2039
Last Update
September 19 2025
Active Locations (9)
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1
University Hospitals Copenhagen - Rigshospitalet
Copenhagen, Denmark
2
Centre Francois Baclesse
Caen, France, 14076
3
Institut Daniel Hollard
Grenoble, France
4
Clinique La Croix Du Sud
Quint-Fonsegrives, France