Oligometastatic Hormone Sensitive Prostate Cancer
Conditions
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.
Interventions
COMBINATION_PRODUCTSBRT on all sites of metastatic disease+Apalutamide
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.
Sponsors
Azienda Ospedaliero-Universitaria Careggi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete biochemical response | 6 months after treatment start. | Rate of patients with complete biochemical response (PSA \< 0.2 ng/ml) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from radiological progression | 2 years after treatment | radiological progression defined according to Prostate Cancer Working Group Criteria |
| Rate of adverse events | 2 years after treatment | measured according to Common Terminology Criteria for Adverse Events |
| Freedom from biochemical progression | 2 years after treatment | Biochemical progression defined according to Prostate Cancer Working Group Criteria |
| Cancer Specific Survival | 2 years after treatment | Time between randomization and death from prostate cancer |
| Health related quality of life | 2 years after treatment | Measured with European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. |
| Overall Survival | 2 years after treatment | Time between randomization and death from any cause |
Countries
Italy
Outcome results
None listed