Actively Recruiting
Surgical Treatment With or Without Apalutamide in Subjects With High Risk Prostate Cancer Who Are Candidates for Radical Prostatectomy and Staged as Oligometastatic With PSMA-PET
Led by Marco Oderda · Updated on 2025-01-06
94
Participants Needed
1
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Surgical Treatment With or Without Apalutamide in Subjects With High Risk Prostate Cancer Who Are Candidates for Radical Prostatectomy and Staged as Oligometastatic With PSMA-PET
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to less than 80 years
- Signed informed consent agreeing to study procedures and restrictions
- Histologically confirmed adenocarcinoma of the prostate
- High-risk disease with Gleason Sum Score 4+4 or higher (Grade Groups 4-5)
- No metastases on conventional imaging
- Low volume metastatic disease on pre-surgery PSMA PET/CT according to CHARTEED criteria
- Candidate for radical prostatectomy with pelvic lymph node dissection
- ECOG Performance Status of 0 or 1
- Adequate organ function with normal liver enzymes and bilirubin, serum creatinine below 1.8 mg/dL, platelet count 75,000/dL or higher, hemoglobin 11.0 g/dL or higher without recent transfusions or growth factors
- Able to receive androgen deprivation therapy for at least 18 months
- Able to swallow whole study drug tablets
You will not qualify if you...
- Distant metastases on conventional imaging; nodal disease below iliac bifurcation is allowed
- Prior hormonal treatment including GnRHa or bilateral orchiectomy
- Previous systemic or local prostate cancer therapy including pelvic radiation or ablative treatments
- Use of investigational agents or therapeutic procedures for prostate cancer within 4 weeks before surgery
- Major surgery within 4 weeks before surgery
- Severe or unstable angina, recent myocardial infarction, symptomatic heart failure, thromboembolic events, significant arrhythmias, or NYHA Class II-IV heart disease within 12 months prior to study drug
- HIV-positive with specific conditions such as lack of antiretroviral therapy or low CD4 count
- History of seizures or conditions predisposing to seizures
- Use of prohibited medications affecting QT interval or seizure threshold within 4 weeks before surgery
- Gastrointestinal disorders affecting drug absorption
- Known allergies or contraindications to apalutamide, GnRHa, or study drug components
- Any condition making study participation unsafe or not in the subject's best interest
- Active malignancies progressing or requiring treatment in past 24 months, except certain treated cancers considered cured
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dept of Surgical Sciences - Urology, Molinette Hospital, University of Torino
Torino, To, Italy, 10126
Actively Recruiting
Research Team
M
Marco Oderda, MD, PhD
CONTACT
G
Giorgio Calleris, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here