Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors

Launched by EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER - EORTC · Jul 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treating prostate cancer called Intermittent Androgen Deprivation Therapy (ADT). The main goal is to see if this method can provide similar benefits to continuous treatment while reducing the time patients need to be on therapy. By doing this, the researchers hope to lessen side effects, improve the quality of life for patients, and make better use of healthcare resources.

To participate in this trial, men aged between 65 and 74 who have been treated with ADT and an androgen receptor pathway inhibitor (ARPI) for at least 6 months and have low prostate-specific antigen (PSA) levels may be eligible. Before enrolling, patients must provide written consent and meet certain criteria, such as not having certain types of cancer or planned surgeries that could interfere with the trial. Throughout the study, participants can expect close monitoring and support as they explore a potentially less burdensome treatment option for their prostate cancer.

Gender

MALE

Eligibility criteria

• 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