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Trial Title:
APalutamiAPalutamide and stEReotactic Body Radiation Therapy for Metastatic Prostate Cancer
NCT ID:
NCT05717660
Condition:
Oligometastatic Hormone Sensitive Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Hypersensitivity
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patients will be randomized between control arm (Androgen Deprivation therapy and
Apalutamide) or treatment arm (Androgen Deprivation therapy and Apalutamide and SBRT on
all sites of metastatic disease)
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
SBRT on all sites of metastatic disease+Apalutamide
Description:
oral Apalutamide 240 mg daily+ stereotactic body radiotherapy on all metastatic sites of
disease, administered in 1-8 fractions for a total EQD2 of 50 Gy with an alpha/beta of
10.
Arm group label:
Control
Arm group label:
Treatment
Summary:
Final results from TITAN trial showed that apalutamide plus ADT improved OS in a
population of patients with metastatic hormone sensitive prostate cancer (mHSPC), if
compared to ADT alone. However, stereotactic body radiotherapy (SBRT) showed to improve
outcomes of oligometastatic patients if compared to systemic therapy alone within modern
randomized trial, including a mixed cohort of different pathologies. However, there are
no trials specifically exploring the benefit offered by SBRT in oligometastatic mHSPC
treated with Apalutamide if compared to Apalutamide alone associated to Androgen
deprivation therapy. Thus, a randomized trial was designed to test specifically the
hypotesis that SBRT will improve outcome in a selected population of oligometastatic
mHSPC treated with Apalutamide and ADT, undergoing baseline staging according to local
reimbursability.
Detailed description:
Prospective Phase II randomized superiority study, open label, multicentric. Patients
with Oligometastatic hormone sensitive prostate cancer defined as presence of ≤ 5
non-visceral metastatic lesions and treated with androgen deprivation treatment
associated with Apalutamide will be randomized to receive standard systemic treatment
alone or concomitant SBRT on all sites of metastatic disease.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients who have signed written informed consent
- Adult patients ≥ 18 years
- Oligometastatic hormone sensitive prostate cancer defined as presence of ≤ 5
non-visceral metastatic lesions *, **
- All lesions must be amenable to SBRT in judgment of treating radiation oncologist
***
- Patients with metastatic recurrence after previous radical prostatectomy or
definitive radiotherapy will be included in the trial, provided that radical
approach on prostate is administered
- Androgen deprivation therapy (ADT) started ≤ 6 months before enrollment
- Patients should be eligible to Apalutamide treatment
Exclusion Criteria:
- Presence of visceral disease
- De novo metastatic disease
- Any contraindication to the use of Apalutamide
- Any condition for which, in the opinion of the treating physician, SBRT should not
be proposed or could be contraindicated
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
AOU Careggi Radiation Oncology Unit
Address:
City:
Florence
Zip:
50134
Country:
Italy
Start date:
March 11, 2023
Completion date:
March 11, 2025
Lead sponsor:
Agency:
Azienda Ospedaliero-Universitaria Careggi
Agency class:
Other
Source:
Azienda Ospedaliero-Universitaria Careggi
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05717660
