This is a phase 2, open-label, randomized study of adjuvant treatment in subjects with high-risk prostate cancer who are candidates for RP with PLND based on M0 status at conventional imaging, but staged as oligometastatic with PSMA PET/CT (performed as routine practice, according to recent evidence on high-risk prostate cancer patients). Ninety-four subjects will receive apalutamide plus ADT or ADT alone after surgery. ADT is defined as medical castration (ie, gonadotropin-releasing hormone analogues \[GnRHa, agonist or antagonist\]). Subjects will be randomly assigned in a 1:1 ratio to receive apalutamide plus ADT or ADT alone.
Patients randomized to receive ADT + apalutamide or ADT alone will begin their adjuvant treatment 4 weeks (28 to 32 days) after surgery. A first dosage of PSA and testosterone will be performed just before starting adjuvant therapy but not before 28 days from surgery. Subsequently, PSA and testosterone dosage and clinical visits will be performed after 3 months from surgery and every 3 months until completion of study. PSMA PET/CT scan will be performed yearly, or in case of PSA progression. The Posttreatment Follow-up Phase will begin after 18 months of ADT and will last for 6 months, until study completion. Afterwards, patients will continue their follow-up according to the best clinical practice.
≥ 18 years of age, < 80 years of age
Signed informed consent form (ICF) indicating that the subject understands the purpose and procedures required for the study and is willing to participate in the study; subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol (Section 4.3)
Histologically confirmed adenocarcinoma of the prostate
High-risk disease defined by a total Gleason Sum Score ≥ 4+4 (=Grade Groups [GG] 4-5)
Distant metastasis based on conventional imaging (CT scan or bone scintigraphy). Nodal disease below the iliac bifurcation (clinical stage N1 at CT scan) is not an exclusion criterion.
Prior hormonal treatment (GnRHa, agonist or antagonist)
Prior bilateral orchiectomy
History of prior systemic or local therapy for prostate cancer, including pelvic radiation and whole gland or focal ablative modalities for prostate cancer
Parallel
Apalutamide
Drugadministration of non steroid androgenic receptor inhibitors plus androgen deprivation therapy
Androgen receptor (AR) inhibitor
Drugadministration of androgen deprivation therapy
Radiological progression-free survival (RPFS)
the time from randomization to date of first PSMA PET/CT-based documentation of progressive disease (appearance of new lesions) or death, whichever occurred first. The RECIP criteria for progression will also be used for the analysis.
Adverse events (AEs)
Adverse events (AEs) will be graded according to the CTCAE version 5.0.
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Marco Oderda
Lead sponsor
A.O.U. Città della Salute e della Scienza
Sponsor institution
