APALUTAMIDE for Metastatic hormone-naïve prostate cancer | Metastatic hormone-sensitive prostate cancer

Inclusion criteria

• {"criterion_text":"- Patient treated with ADT (luteinizing hormone–releasing hormone (LHRH) agonist or antagonist) and an ARpI for mHNPC for 6-12 months and presenting with a PSA ≤ 0.2 ng/mL"}
• {"criterion_text":"- Patients with synchronous or metachronous metastases, high volume or low volume/risk who fulfil the criteria can be included."}
• {"criterion_text":"- Before patient's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations"}

Exclusion criteria

• {"criterion_text":"- 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"}
• {"criterion_text":"- Patients who underwent or will undergo a bilateral orchiectomy"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patients who have received a systemic anti-prostate cancer treatment not approved by EMA together with MAB or a radical prostatectomy for M1 disease"}
• {"criterion_text":"- 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"}

Primary endpoints

• {"endpoint_text":"- Proportion of patients who do not restart their hormonal therapy within 1 year of interrupting their MAB therapy","definition_or_measurement_approach":"Measured as the proportion of randomized patients in the iMAB arm who have not restarted hormonal therapy within 1 year after MAB interruption (feasibility endpoint)."}
• {"endpoint_text":"- Overall survival (from randomization)","definition_or_measurement_approach":"Measured as overall survival (OS) from date of randomization (non-inferiority endpoint)."}

Secondary endpoints

• {"endpoint_text":"- Safety according to the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0 for toxicity of grade 3 or higher Adverse Events, Adverse Events of Special Interest, and Serious Adverse Event reporting","definition_or_measurement_approach":"Safety assessed per CTCAE v5.0; reporting of Grade ≥3 adverse events, AEs of special interest and SAE reporting."}
• {"endpoint_text":"- The magnitude of change from baseline to 1 year in HRQoL in terms of physical functioning from the EORTC QLQ-C30, and sexual activity, pain and physical fatigue from the IL249 item list","definition_or_measurement_approach":"Change from baseline to 1 year in specified HRQoL domains measured by EORTC QLQ-C30 and IL249 item list."}
• {"endpoint_text":"- Time spent on MAB treatment","definition_or_measurement_approach":"Duration on MAB treatment measured in time units (time on treatment)."}
• {"endpoint_text":"- Time to next systemic prostate cancer therapy","definition_or_measurement_approach":"Time from randomization to initiation of next systemic prostate cancer therapy."}
• {"endpoint_text":"- Health utility derived from patient reported QLQ-C30 data and patient demographics","definition_or_measurement_approach":"Health-utility estimates derived from QLQ-C30 patient-reported outcomes combined with demographics for health economic analyses."}
• {"endpoint_text":"- The magnitude of change in HRQoL in terms of physical functioning from EORTC QLQ-C30, and sexual activity, pain characteristics and physical fatigue from the IL249 item list, from baseline to three years","definition_or_measurement_approach":"Change from baseline to 3 years in specified HRQoL domains measured by EORTC QLQ-C30 and IL249."}
• {"endpoint_text":"- Change in HRQoL in terms of the pain and emotional functioning and cognitive functioning scales of EORTC QLQ-C30, and hormonal treatment-related symptoms scale of EORTC IL249 among patients treated with iMAB compared to those on continuous treatment from baseline to one year and three years","definition_or_measurement_approach":"Between-arm comparisons of changes from baseline to 1 and 3 years in specified QLQ-C30 and IL249 scales."}
• {"endpoint_text":"- Change in HRQoL in terms the remaining scales the EORTC QLQ-C30 and IL249 among patients treated with iMAB compared to those on continuous treatment from baseline to one year and three years","definition_or_measurement_approach":"Between-arm comparisons of remaining QLQ-C30 and IL249 scales from baseline to 1 and 3 years."}
• {"endpoint_text":"- Evolution of HRQoL in terms of all the scales from EORTC QLQ-C30 and EORTC IL249 among patients in the iMAB and cMAB arms respectively","definition_or_measurement_approach":"Longitudinal description of HRQoL scale scores across arms using QLQ-C30 and IL249."}
• {"endpoint_text":"- OS and prostate cancer specific survival from start of MAB treatment","definition_or_measurement_approach":"Overall survival and prostate cancer-specific survival measured from start of MAB treatment."}
• {"endpoint_text":"- Proportion of patients with recovered testosterone levels (testosterone > 150 ng/dL) at 1 and 3 years after interrupting their MAB therapy","definition_or_measurement_approach":"Proportion of patients with testosterone >150 ng/dL at 1 and 3 years after MAB interruption."}
• {"endpoint_text":"- Proportion of patients with PSA ≤ 0.2 ng/mL at 3 years after interrupting their MAB therapy","definition_or_measurement_approach":"Proportion of patients maintaining PSA ≤0.2 ng/mL at 3 years post interruption."}
• {"endpoint_text":"- Testosterone and PSA value profiles during the first 3 years","definition_or_measurement_approach":"Serial testosterone and PSA measurements summarized over first 3 years."}
• {"endpoint_text":"- Prostate cancer specific survival","definition_or_measurement_approach":"Survival with death attributed to prostate cancer (time-to-event)."}
• {"endpoint_text":"- Enrolment rates via screening log and patient accrual.","definition_or_measurement_approach":"Recruitment performance measured via screening logs and accrual counts."}

Croatia

Earliest CTIS Part Ii Submission Date

31-03-2025

Latest Decision Or Authorization Date

04-04-2025

Processing Time Days

4

Number Of Sites

1

Number Of Participants

41

France

Earliest CTIS Part Ii Submission Date

23-01-2025

Latest Decision Or Authorization Date

02-04-2025

Processing Time Days

69

Number Of Sites

38

Number Of Participants

460

Denmark

Earliest CTIS Part Ii Submission Date

18-03-2025

Latest Decision Or Authorization Date

01-04-2025

Processing Time Days

14

Number Of Sites

2

Number Of Participants

36

Ireland

Earliest CTIS Part Ii Submission Date

05-03-2025

Latest Decision Or Authorization Date

04-04-2025

Processing Time Days

30

Number Of Sites

10

Number Of Participants

144

Belgium

Earliest CTIS Part Ii Submission Date

04-03-2025

Latest Decision Or Authorization Date

01-04-2025

Processing Time Days

28

Number Of Sites

12

Number Of Participants

150

Czechia

Earliest CTIS Part Ii Submission Date

10-03-2026

Latest Decision Or Authorization Date

29-04-2026

Processing Time Days

50

Number Of Sites

2

Number Of Participants

35

Spain

Earliest CTIS Part Ii Submission Date

27-02-2025

Latest Decision Or Authorization Date

03-04-2025

Processing Time Days

35

Number Of Sites

23

Number Of Participants

378

Primary sponsor

Full Name

European Organisation For Research And Treatment Of Cancer

Organisation Type

Patient organisation/association

Country Of Registered Address

Belgium

Third parties

• {"country":"France","full_name":"Unicancer","duties_or_roles":"Collaborative group in charge of site management in France","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Ireland","full_name":"Cancer Trials Ireland","duties_or_roles":"Collaborative group in charge of site management in Ireland","organisation_type":"Patient organisation/association"}
• {"country":"Spain","full_name":"Grupo Espanol De Oncologia Genitourinaria-Socug","duties_or_roles":"network support","organisation_type":"Patient organisation/association"}