APalutamide and stEReotactic Body Radiation Therapy for Low Burden Metastatic Hormone senSItive Prostate Cancer, a rANdomized Trial - PERSIAN
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Complete biochemical response
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control
Androgen Deprivation therapy and Apalutamide
Intervention: SBRT on all sites of metastatic disease+Apalutamide (Combination Product)
Treatment
Androgen Deprivation therapy and Apalutamide and SBRT on all sites of metastatic disease
Intervention: SBRT on all sites of metastatic disease+Apalutamide (Combination Product)
Outcomes
Primary Outcomes
Complete biochemical response
Time Frame: 6 months after treatment start.
Rate of patients with complete biochemical response (PSA \< 0.2 ng/ml)
Secondary Outcomes
- Cancer Specific Survival(2 years after treatment)
- Health related quality of life(2 years after treatment)
- Freedom from biochemical progression(2 years after treatment)
- Freedom from radiological progression(2 years after treatment)
- Rate of adverse events(2 years after treatment)
- Overall Survival(2 years after treatment)
Investigators
Lorenzo Livi
Full Professor
Azienda Ospedaliero-Universitaria Careggi