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Recruiting Phase 3

Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors

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About this study

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.

Condition
Prostate Cancer
Tested
iMAB, cMAB
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

Who can join

Age
18 to 100 years
Sex
Male only
Healthy volunteers
Not accepted

Inclusion 6

  • Minimum age: 18 years
  • Maximum age: 100 years
  • Eligible sex: Male
  • Study condition: Prostate Cancer
  • 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 5

  • 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

9 sites, 9 recruiting

University Hospitals Copenhagen - Rigshospitalet

Copenhagen, Denmark

Recruiting

Centre Francois Baclesse

Caen, France

Recruiting

Institut Daniel Hollard

Grenoble, France

Recruiting

Clinique La Croix Du Sud

Quint-Fonsegrives, France

Recruiting

CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole

Toulouse, France

Recruiting

Gustave Roussy

Villejuif, France

Recruiting

and 3 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.