Rate of PSA Response in Oligometastatic,CRPC Undergoing SBRT in Combination With Abiraterone Acetate (AA), Compared to Patients Treated With AA Alone Clinical Trial
— ARTOOfficial title:
A 2 Arm, Phase II Controlled Randomized Trial Comparing Efficacy and Safety of Abiraterone and Abiraterone Associated With of Ablative Radiation Therapy in Patients With Oligometastatic Castration Resistant Prostate Cancer (ARTO Trial)
Metastatic castration resistant prostate cancer causes approximately 258400 deaths annually
worldwide.
In the presence of metastatic disease, systemic treatment remains the main clinical option.
However, since the introduction of highly sensitive imaging techniques, a new clinical entity
of metastatic patients with a limited number of lesions has been defined: oligometastatic
patients.
Although a clear benefit has yet to be demonstrated in this group of patients, the use of
stereotactic body radiotherapy (SBRT) or other local therapies directed against all active
lesions has been suggested as a possible salvage treatment.
Irradiation of metastatic foci may delay the emergence of castration resistance because
irradiation is effective against both ADT¬ sensitive and ADT ¬resistant prostate cancer cells
as shown in re-biopsy studies. Stereotactic body radiation therapy has been used in this
setting to defer the initiation of ADT in patients with oligometastatic prostate cancer with
notable results.
Abiraterone acetate is a first class inhibitor of cytochrome P ¬450c17, a critical enzyme in
extragonadal and testicular androgen synthesis. Abiraterone plus low dose prednisone improves
survival in patients with metastatic castration ¬resistant prostate cancer who have already
received docetaxel and the combination therapy has received regulatory approval for this
indication. Furthermore, Abiraterone acetate is approved also in patients who did not undergo
to docetaxel chemotherapy, after the results from the COU-AA 302 study; Results from this
phase III trial confirmed the benefit in chemo-naïve patients treated with abiraterone
acetate both in terms of overall and radiological progression free survival, if compared to
placebo.
In oligometastatic CRPC, the rationale to use SBRT is that the addition of a local ablative
treatment could improve disease control in mCRPC patients treated with a systemic therapy.
The current phase II randomized trial,"Ablative Radiation Therapy in patients with
Oligometastatic castration resistant prostate cancer (ARTO trial)" aims to evaluate the
difference in PSA response rate between the experimental arm (AA+SBRT) and control arm (AA)
in metastatic castration-resistant prostate cancer patients
| Status | Not yet recruiting |
| Enrollment | 174 |
| Est. completion date | May 1, 2022 |
| Est. primary completion date | September 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Each potential subject must satisfy all of the following criteria to be enrolled in the study. 1. Metastatic disease and only <3 metastatic sites recorded (irrespective if nodal or bone). 2. Patients should have received abiraterone acetate for 30 days before eventual start of radiotherapy in the experimental arm (+/- 3 days) 3. Asymptomatic or mildly symptomatic patients according to clinical judgement. 4. Age = 18 years. 5. 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) |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Lorenzo Livi |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | rate PSA | rate of PSA response in nodal and/or bone oligometastatic (?3 lesions), castration resistant prostate cancer patients undergoing SBRT in combination with AA (experimental arm), compared to patients treated with AA (control arm). PSA response will be defined as a post-treatment decrease > 50% from baseline measured within 6 months. | within 6 months |