A Randomized, open-label, Phase 2 Study of Adjuvant Apalutamide or Standard of Care in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer After Radical Prostatectomy

Universitaet Muenster16 sites in 2 countries190 target enrollmentSeptember 20, 2024

DrugsJNJ-56021927

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Universitaet Muenster
Enrollment: 190
Locations: 16
Primary Endpoint: Progression-free survival (PFS). This endpoint is defined as time interval from randomization until BCR, metastases, or death from any cause, whichever occurs first.
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To determine if adjuvant apalutamide in prostate cancer patients at high risk of developing subsequent metastatic disease results in prolonged biochemically recurrence-free survival after radical prostatectomy (RPE) in comparison to standard of care (SOC).

Registry

euclinicaltrials.eu

Start Date

September 20, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

Universitaet Muenster

Responsible Party

Principal Investigator

Klinik für Urologie und Kinderurologie am UKM Münster

Scientific

Universitaet Muenster

Eligibility Criteria

Inclusion Criteria

•Signed informed consent form (ICF)
•Ability to swallow study medication tablets
•In case of apalutamide treatment: Agrees to use a condom and another highly effective method of birth control if he is having sex with a woman of childbearing potential or to use a condom if he is having sex with a woman who is pregnant
•Men ≥ 18 years of age
•Patients with histologically confirmed adenocarcinoma of the prostate after radical prostatectomy
•Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
•Exclusion of metastatic disease by CT-scan of abdomen (MRI of abdomen is possible) and bone scan prior to study inclusion. A PSMA PET-CT/MRI is possible. In this case it has to be done with a diagnostic CT/MRI with contrast media and not with a low dose CT-scan only. In case PSMA-PET imaging has been done, a bone scan can be omitted. CT/MRI, and bone-scan imaging or PSMA PET-CT/MRI administered ≤12 weeks before RPE may be used for screening
•Patients after RPE must meet the d'Amico criteria for high risk of disease recurrence (T-stage and Gleason-score determined after radical prostatectomy) i.e. 1 of the following after RPE: 1) Gleason score ≥8, any T-stage, any iPSA or 2) Gleason score 6 or 7, any iPSA and ≥pT3 or 3) iPSA >20 ng/ml, any Gleason score, any T-stage.
•Patients have to have recovered from radical prostatectomy within eight weeks to be able to take part in the study
•PSA must have declined below 0.2 ng/ml prior to randomization

Exclusion Criteria

•Any chronic medical condition requiring a higher dose of corticosteroid than 10mg prednisone/prednisolone q.d.
•Any lymph node or distant metastasis
•History of seizures or condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness ≤1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect).
•Current or prior treatment with anti-epileptic medications for the treatment of seizures
•Management of cardiovascular risk factors, such as hypertension, diabetes or dyslipidaemia should be optimised as per standard of care before treatment with apalutamide will be initiated 13.
•Uncontrolled hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg. For patients with relevant comorbidities (e.g. diabetes) systolic BP ≥130 mmHg or diastolic BP ≥80 mmHg). Patients with a history of hypertension are allowed provided that blood pressure is controlled by anti-hypertensive treatment 13.
•Patients with uncontrolled diabetes defined as HbA1c ≥7.5% 13.
•Patients with a dyslipidemia defined as LDL cholesterol >100 mg/dl. For patients with a dyslipidemia defined as LDL cholesterol >100 mg/dl and SCORE-value of 1-5%: In case of a SCORE-value of <1% a LDL cholesterol level of up to 115 mg/dl is acceptable. In case of increased LDL cholesterol above these values a statin-therapy can be initiated and a rescreening within 4 weeks is possible 13.
•Cardiovascular risk assessment via an appropriate score (e.g. the SCORE-Chart for the European high/low risk score from the European Society of Cardiology) and ≥ borderline risk i.e. 10% of developing cardiovascular events within 10 years without prior cardiovascular disease
•Active or symptomatic viral hepatitis or chronic liver disease or HIV

Outcomes

Primary Outcomes

Progression-free survival (PFS). This endpoint is defined as time interval from randomization until BCR, metastases, or death from any cause, whichever occurs first.