Phase II Randomized Trial of Radiation Therapy in Oligometastatic mCRPC Prostate Cancer (ARTO) (ARTO)
Rate of PSA Response in Oligometastatic,CRPC Undergoing SBRT in Combination With Abiraterone Acetate (AA), Compared to Patients Treated With AA Alone
About this trial
This is an interventional treatment trial for Rate of PSA Response in Oligometastatic,CRPC Undergoing SBRT in Combination With Abiraterone Acetate (AA), Compared to Patients Treated With AA Alone
Eligibility Criteria
Inclusion Criteria:
Each potential subject must satisfy all of the following criteria to be enrolled in the study.
- Metastatic disease and only <3 metastatic sites recorded (irrespective if nodal or bone).
- Patients should have received abiraterone acetate for 30 days before eventual start of radiotherapy in the experimental arm (+/- 3 days)
- Asymptomatic or mildly symptomatic patients according to clinical judgement.
- Age ≥ 18 years.
- Subject must have signed an informed consent document indicating that they understand the purpose of procedures required for the study and are willing to participate in the study
Exclusion Criteria:
1. More than 3 metastatic lesions.
2. Visceral involvement.
3. Known or suspected contraindications or hypersensitivity to Abiraterone, GnRH agonist/antagonist or Radiotherapy.
4. Comorbidities that contraindicate Abiraterone, GnRH agonist/antagonist or Radiotherapy.
5. Any condition for which, in the option of the investigator, participation would not be in the best interest of subject.
6. Patients who received previous therapies for mCRPC (excluded hormonal therapy)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Abiraterone
Abiraterone associated withAblative Radiation
The treatment phase consists of systemic treatment with abiraterone acetate 1000 mg daily and prednisone 10 mg daily, plus GnRH agonist or antagonist (control arm).
the patients in the experimental arm will receive SBRT to all metastatic lesions, concomitantly with abiraterone acetate. SBRT will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Considering an Alfa/beta of 3, a BED3 > 100 Gy is recommended