mCSPC and the TITAN Study
Dr Petrylak recalls the study design and results of the TITAN study.
Dan Petrylak, MD: The TITAN trial was a phase 3 study that randomized men with castration-sensitive prostate cancer metastatic disease to 240 mg/day of apalutamide or placebo. Patients were allowed to have prior treatment for localized therapy, as well as prior docetaxel therapy. There were 525 patients that were randomized in the trial. Overall, about 2/3 had high volume disease, and about 1/3 had low volume disease. With the first interim analysis of the median of about 23 months, there was an improvement in radiographic progression-free survival and the overall survival 24 months was better in the apalutamide arm than the placebo arm. 82% were live in the apalutamide arm versus 73% of the placebo arm. The hazard ratio for death was 0.67. This demonstrates that the RPFS [Radiographic Progression-Free Survival] and overall survival were longer in patients who received apalutamide and hormone-sensitive state compared to the patients who received placebo.
One of the concerns with adding apalutamide to these patients with castration-sensitive prostate cancers is: are you having more side effects with this drug? Are you training the survival benefit for more toxicity and degradation of the quality of life? Some very interesting observations were made in this study: we see that the meeting time towards pain intensity and pain progression was improved. The FACT-P scores were also improved in the patients who received apalutamide. Generally, the quality-of-life parameters were better. The health-related quality of life parameters were better in those patients who received apalutamide versus those patients who received placebo. That would be due to a direct effect that occurs on the tumor cel
ls and helping control tumor-related symptoms.
This transcript has been edited for clarity.
Case 1: An 80-Year-Old Man With Metastatic Castration-Sensitive Prostate Cancer
Initial presentation
- An 80-year-old man presents with nocturia and decreased appetite
- He has mild pain in his hip and lower back
Patient History, Lifestyle and Clinical workup
- No family history of prostate cancer
- Patient is a widower without transportation for regular medical visits
- He is physically frail but his cognitive function is good
- TRUS and biopsy revealed adenocarcinoma of the prostate gland, Gleason grade group 3 [3+4] with disease in 8/12 cores.
- PSA 500 ng/mL; Hb 9.4 g/dL; ANC 1.5
- Bone and CT scans showed 1 metastatic lesion in the pelvis
Diagnosis
- Patient is diagnosed with de novo metastatic castration-sensitive prostate cancer
- Germline genetic testing is negative
Treatment
- Patient is started on ADT at diagnosis with initial decrease in PSA
- He expresses interest in receiving more intensive treatment to control his PSA
- However, he does not want to receive chemotherapy since he has heard about the risk of side effects
- He is looking for a treatment option that will allow him to have a good quality of life
- Due to his frailty, inability to make frequent medical visits and request not to receive chemotherapy, the patient is treated with ADT + apalutamide
- At his 1-year follow-up, the patient’s PSA remains undetectable, and he continues to report a good quality of life
Case 2: A 62-Year-Old Man With Metastatic Castration-Sensitive Prostate Cancer
Initial Presentation:
- A 62-year-old man presents to the emergency room with progressive fatigue, low back pain, decreased appetite, weight loss, abnormal rectal exam and urinary retention
Patient History, Lifestyle and Clinical workup
- Past medical history is unremarkable
- No family history of prostate cancer
- Biopsy revealed adenocarcinoma of the prostate gland, Gleason grade [4+4] with disease in 8/12 cores.
- PSA 200 ng/mL; Hb 9.5 g/dL; ANC 1.7
- Bone and CT scans showed 2 metastatic lesions in the pelvis
- ECOG PS is 1
Diagnosis
- Patient is diagnosed with de novo metastatic castration-sensitive prostate cancer
- Germline genetic testing is negative
Treatment
- Patient is started on ADT plus abiraterone at diagnosis with initial decrease in PSA
