Matthew R. Smith, MD, PhD: My personal experience with darolutamide is well aligned with the published results from the ARAMIS study. The drug has a favorable safety profile. We participated in the ARAMIS trial and, candidly, it was quite difficult to distinguish between placebo and darolutamide treatment patients during the blinded portion of the trial. My post-approval experience has been similar to that. Patients report a good quality of life during treatment. It would be rare to require a treatment interruption or dose reduction with darolutamide, so the tolerability has been consistent with what's been reported from the ARAMIS trial. Our efficacy experience is similar with most patients experiencing durable PSA response and relatively long time to progression before requiring a change in systemic treatment.
Transcript edited for clarity.
Case: A 82-Year-Old Man with Metastatic Castration-Resistant Prostate Cancer
A 82-year-old man with nocturia
Abnormal digital rectal exam, PSA 31 ng/mL
No family history of prostate cancer
Diabetes and hypertension, both of which are managed with medications, neuropathy and uses a cane for long distances
Prostate biopsy confirms advanced adenocarcinoma of the prostate and Gleason score of 8 (4 + 4)
Bone scans show no detectable spread to bone, abdominal pelvic CT scan shows enlarged pelvic and retroperitoneal nodes consistent with metastatic prostate cancer.
His ECOG PS is 1
Patient starts continuous ADT in October 2016.
PSA levels go down to undetectable levels within 3 months after start of treatment. Levels are checked every 3 months thereafter.
Patient undergoes repeat abdominal pelvic CT scan after completing a year of therapy which show resolution of pelvic and retroperitoneal nodes.
An increase in PSA is seen and PSA levels are 2.7 ng/ml, with PSA doubling time of 6 months
Patient undergoes conventional imaging with bone scan and CT that show no detectable prostate cancer.
PSMA PET scan shows multiple areas of increased uptake in pelvis and retroperitoneum, consistent with previously identified sites of metastasis.
Lab tests are normal and patient has adequate liver, renal and bone marrow function.
Patient is treated with enzalutamide (160 mg/day) and PSA levels decline
After some time on enzalutamide, patient decides to discontinue treatment due to fatigue and problems with gait.
Symptoms resolve on their own after going off treatment for a few months
Patient is started on darolutamide and continued ADT (leuprolide depot) and remains on this treatment