Actively Recruiting
Multimodal Approach in Patients With mHSPC. Randomized Trial of APA+ADT vs APA-ADT and Local Treatment
Led by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Updated on 2025-09-03
566
Participants Needed
3
Research Sites
304 weeks
Total Duration
On this page
Sponsors
F
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead Sponsor
A
ASST Santi Paolo e Carlo
Collaborating Sponsor
AI-Summary
What this Trial Is About
Italian multicenter study, will enroll \~566 pts with oligometastatic hormone sensitive prostate cancer who are candidates to receive treatment with apalutamide. After 6 months from the start of treatment, patients will be randomized to receive local treatment based on the investigator's choice ( either one between primary radiotherapy or cytoreductive prostatectomy), in addition to apalutamide, or to continue just with medical therapy.
CONDITIONS
Official Title
Multimodal Approach in Patients With mHSPC. Randomized Trial of APA+ADT vs APA-ADT and Local Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged over 18 years
- Histologically confirmed prostate adenocarcinoma
- Metastatic disease with at least one bone lesion documented by Technetium 99m bone scan, with CT or MRI confirmation if only one lesion
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 2 or less
- No previous treatment with antiandrogens or GnRH analogues or treatment duration three months or less
- No previous systemic or local treatment for prostate adenocarcinoma including pelvic radiotherapy
- Laboratory values at screening: neutrophils at least 1500/µL, hemoglobin at least 9.0 mg/µL without transfusions in past 28 days, platelets at least 100,000/µL, creatinine no greater than twice the upper limit of normal, serum albumin at least 3.0 g/dL, total bilirubin no greater than 1.5 times upper limit of normal (with specific considerations for Gilbert syndrome), AST and ALT no greater than 2.5 times upper limit of normal
- Able to swallow apalutamide tablets whole
- Signed informed consent and willingness to comply with study procedures
- For cytoreductive surgery: age over 18, clinical stage cT3, robot-assisted radical prostatectomy with iliac obturator lymphadenectomy, and surgical specimen management similar to Proteus criteria
You will not qualify if you...
- Pathologic findings of small cell, ductal, or neuroendocrine prostate cancer
- Known brain metastases
- Presence of only lymph node metastases
- Presence of visceral metastases
- Ineligibility for surgery or radiotherapy
- Unacceptable cardiovascular risk including unstable angina, recent myocardial infarction, symptomatic congestive heart failure, significant thromboembolic events, or ventricular arrhythmias within 6 months prior to randomization
- Uncontrolled high blood pressure (systolic >160 mmHg or diastolic >100 mmHg)
- Prior treatment with antiandrogens, GnRH analogues, or other systemic prostate cancer treatments
- Prior local treatment with surgery and/or radiotherapy
- Any prior malignancy within 5 years except certain treated skin or bladder carcinomas
- Known allergies or intolerance to apalutamide excipients
- Receipt of blood transfusions, hematopoietic growth factors, or major surgery within 28 days prior to randomization
- Symptomatic or chronic viral hepatitis, chronic liver disease, moderate to severe liver failure, encephalopathy, ascites, or thrombo-hemorrhagic disorders from liver failure
- Gastrointestinal disorders affecting drug absorption
- Active infections requiring systemic therapy such as HIV
- Any condition judged by investigator to preclude trial participation
- Contraindication for surgery for those considered for cytoreductive surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
European Institute of Oncology
Milan, Lombardy, Italy, 20141
Not Yet Recruiting
2
ASST Santi Paolo e Carlo
Milan, Lombardy, Italy, 20153
Not Yet Recruiting
3
Istituto Tumori Milano
Milan, Mi, Italy, 20156
Actively Recruiting
Research Team
V
Valentina Guadalupi, 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