Status:
UNKNOWN
Phase II Randomized Trial of Radiation Therapy in Oligometastatic mCRPC Prostate Cancer (ARTO)
Lead Sponsor:
Lorenzo Livi
Conditions:
Rate of PSA Response in Oligometastatic,CRPC Undergoing SBRT in Combination With Abiraterone Acetate (AA), Compared to Patients Treated With AA Alone
Eligibility:
MALE
Phase:
NA
Brief Summary
Metastatic castration resistant prostate cancer causes approximately 258400 deaths annually worldwide. In the presence of metastatic disease, systemic treatment remains the main clinical option. Howe...
Detailed Description
This phase II randomized trial was designed to evaluate the difference in PSA response rate between the experimental arm (AA+SBRT) and control arm (AA). PSA response will be defined as a post-treatmen...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2022
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT03449719
Start Date
May 1 2018
End Date
May 1 2022
Last Update
February 28 2018
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