Inducta

Trial details

Who runs it

Universitaet Des Saarlandes

Trial code

EU 2023-509837-37-00

Record updated

2025. május 2.

Original description

The primary objective of this study is to assess operability in patients with locally advanced T4 high risk prostate cancer upon inductive preprostatectomy treatment with apalutamide plus ADT for a duration of up to 6 months.Read full original descriptionShow less

A feasibility trial investigating inductive Apalutamide therapy combined with radical prostatectomy in patients with locally advanced T4 high risk prostate cancer

The primary objective of this study is to assess operability in patients with locally advanced T4 high risk prostate cancer upon inductive preprostatectomy treatment with apalutamide plus ADT for a duration of up to 6 months.

Inclusion: Male of 18 to 80 years of age, inclusive; Must agree to wear a condom when engaging in any activity that allows for passage of ejaculate to another person while on study drug and for 3 months following the last dose of study drug; Must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last dose of IMP; Must sign an ICF indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study; Histologically confirmed adenocarcinoma of the prostate without complete neuroendocrine differentiation or small cell features; cT4 PCa, considered as primary inoperable because of a fixed mass defined by digital rectal examination, confirmed by advanced disease in MRI; Eastern Cooperative Oncology Group Performance Status 0 or 1, patients must and are expected to be fit and willing to undergo radical prostatectomy within 6 to 9 months after start of study treatment; Adequate organ function determined by the following laboratory values: a.Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and total bilirubin less than twice the upper limit of normal b.Platelets ≥100,000/L, independent of transfusion and/or growth factors within 1 month prior to enrolment; At least 4 weeks must have elapsed from the use of 5-alpha reductase inhibitors and estrogens prior to enrolment; No irradiation of the pelvis; Be able to swallow whole study drug tablets; Not candidate for radiotherapy or who deny radiotherapy.

Exclusion: Patient has received another investigational medication (including investigational vaccines) or used another invasive investigational medical device within 30 days before the planned first dose of the IMP of this study or is currently enrolled in another investigational study; Prior treatment with second generation anti-androgens; Prior treatment with CYP17 inhibitors; Prior treatment with systemic glucocorticoids ≤4 weeks prior to enrolment or patient expected to require long-term use of corticosteroids during the study; Use of 5-α reductase inhibitors (eg, dutasteride, finasteride) ≤4 weeks prior to enrolment; Major surgery ≤4 weeks prior to enrolment; Prior treatment with radiopharmaceutical agents; Prior chemotherapy for prostate cancer; History of any pelvic radiation; History or evidence of any of the following conditions: any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to enrolment; severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events, or clinically significant ventricular arrhythmias within 6 months; uncontrolled hypertension; history of seizure or convulsion; gastrointestinal disorder affecting absorption; active infection; and, any other condition that, in the opinion of the investigator, would impair the patient's ability to comply with study procedures; Active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction; Any active infection requiring systemic therapy; Known or suspected contraindications or hypersensitivity to apalutamide, or GnRH agonists or any of the components of the formulations; Patient is eligible for PROTEUS study (all patients with operable, non T4 disease); Pathological finding consistent with small cell, ductal, or complete neuroendocrine prostate cancer; Presence of any of the following cardiologic criteria: a) Mean resting QTc >470 msec b) In patients with a history of risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval, the benefit-risk ratio including the potential for Torsade de pointes will be carefully assessed and patients will be excluded if the benefit-risk ratio is considered as unfavorable; Presence of distant metastasis (clinical stage M1) after MRI, CT abdomen and bone scan Note: Patients with distant metastases only detectable in PSMA-PET/CTs are allowed to be included in the trial when conventional imaging (CT and bone scan) is negative for distant metastases; Bilateral orchiectomy.

EU CTIS 2023-509837-37-00