A phase II randomized trial of Observation versus stereotactic ablative RadiatIon for OLigometastatic prostate CancEr (ORIOLE): Beyond the Abstract
In general, this old treatment paradigm says that patients who have localized disease benefit mostly from local therapies like surgery and radiation and very little from systemic treatment like hormones and chemotherapy. There is some provocative data, generally lower level of evidence—what we call retrospective data—and a recent prospective randomized trial, so higher level of evidence, which suggests this approach of giving local therapy to those with only a few metastases may increase survival. So the concept is—if you treat not only the primary disease in the prostate or the pelvis, but also the few metastatic lesions, perhaps men can actually live a long time without disease progression and/or be cured.
From a radiation oncology perspective, there has been a lot of technological growth over the last 15 to 20 years, which has culminated into an approach called stereotactic body radiation therapy (SBRT) or stereotactic ablative radiation (SABR). SBRT and SABR are highly focused radiation given in an intense fashion. I tell patients it’s like spot welding—small area, very intense, and theoretically ablative, meaning it kills all the cancer in that spot.
Armed with this new SABR technology and with the idea that local therapies such as surgery, radiation, and other ablative therapies can be beneficial in oligometastatic patients, we wanted to test our idea in a rigorous way. As I stated there is some data suggesting there may be a benefit from local therapies like surgery and radiation to oligometastatic patients, but there is not, at least in prostate cancer, good data from randomized clinical trials.
Our trial is a randomized trial of patients with oligometastatic prostate cancer defined as three or fewer metastases. Men have to have received treatment for the primary prostate disease, so surgery or radiation, and have had no hormonal therapy for their metastatic disease. They can have had hormonal therapies in conjunction with treatment for their primary disease, but not for their metastatic disease. Patients are randomized to either SABR to up to three sites or a short observation period of three to six months. The randomization is 2:1 to SABR versus a short no longer than 1-6-month observation period after which they can cross over to the SABR treatment.
Also, the metastatic tumors have to be of a certain bulk or size—they can’t be too large. Patients have to have a PSA doubling time of less than 15 months (PSA doubling time is the time it takes for the PSA to double.) We chose less than 15 months because there are patients who have biochemical failure or low-volume metastatic disease with long PSA doubling times, sometimes many years and they probably don't need any treatment immediately or possibly ever. PSA doubling time less than 15-months allows us to zero in on patients for whom SABR treatment may make a difference. We have been enrolling quickly, now 31 men out of 54 total over the past year.
Thus far, as expected only minimal side-effects from the SABR and all men continue to work and resume normal activities during the short generally less than 2-3 week treatment. Results although very preliminary look promising. The trial also has a number of cutting-edge correlative genetic, blood and imaging studies associated with it that men would not have access to otherwise. If men appear eligible and are interested please contact me directly at .
Written By: Phuoc T Tran, Johns Hopkins University School of Medicine
Read the Abstract
RadiatIon for OLigometastatic prostate CancEr (ORIOLE): Clinical Trial Information