Actively Recruiting
Surgical Treatment With or Without Apalutamide in High-Risk Prostate Cancer Patients Who Are Candidates for Radical Prostatectomy and Staged as Oligometastatic by 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
Researchers are evaluating adjuvant treatments for men with high-risk prostate cancer who are candidates for radical prostatectomy with pelvic lymph node dissection and are staged as having low volume metastatic disease based on PSMA PET/CT scans. This phase 2, open-label, randomized study compares apalutamide plus androgen deprivation therapy (ADT) with ADT alone. The study focuses on patients who have no metastases on conventional imaging but have oligometastatic disease detected by PSMA PET/CT, aiming to assess outcomes after surgery. Participants will be randomly assigned to two groups: one receiving apalutamide combined with ADT, and the other receiving ADT alone. The adjuvant treatment begins approximately 4 weeks after surgery. ADT involves medical castration using gonadotropin-releasing hormone analogues. PSA and testosterone levels are measured before starting therapy and then every 3 months during treatment. PSMA PET/CT scans are done yearly or upon PSA progression. After 18 months of ADT treatment, there is a 6-month posttreatment follow-up phase. During the study, participants undergo regular clinical visits, PSA and testosterone testing, and imaging scans to monitor disease status and treatment effects. Radiological progression-free survival is measured from randomization up to 24 months, including 6 months posttreatment follow-up. After completion, patients continue follow-up according to standard clinical practice. The total study duration includes 18 months of treatment and 6 months of follow-up.
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
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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
G
Giorgio Calleris, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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