Clinical trial NCT05717660: APalutamiAPalutamide and stEReotactic Body Radiation Therapy for Metastatic Prostate Cancer
Official title: APalutamide and stEReotactic Body Radiation Therapy for Low Burden Metastatic Hormone senSItive Prostate Cancer, a rANdomized Trial - PERSIAN
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Oligometastatic Hormone Sensitive Prostate Cancer
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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

Primary outcomes:
measure: Complete biochemical response
timeFrame: 6 months after treatment start.
Secondary outcomes:
measure: Freedom from biochemical progression
timeFrame: 2 years after treatment
measure: Freedom from radiological progression
timeFrame: 2 years after treatment
measure: Rate of adverse events
timeFrame: 2 years after treatment
measure: Overall Survival
timeFrame: 2 years after treatment
measure: Cancer Specific Survival
timeFrame: 2 years after treatment
measure: Health related quality of life
timeFrame: 2 years after treatment
measure: Health related quality of life
timeFrame: 2 years after treatment
Other outcomes:
Locations:
city: Florence
country: Italy
facility: AOU Careggi Radiation Oncology Unit
Study officials:
References:
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