Phase II Randomized Trial of Radiation Therapy in Oligometastatic mCRPC Prostate Cancer (ARTO)
Status:
Not yet recruiting
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
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.
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