Castrate-Sensitive Prostate Cancer: TITAN Trial Outcomes

EP: 1.Case Overview: Castrate-Sensitive Prostate Cancer

EP: 2.Managing Castrate-Sensitive Prostate Cancer

EP: 3.Castrate-Sensitive Prostate Cancer: Frontline Therapy

EP: 4.Castrate-Sensitive Prostate Cancer: Treatment Planning

EP: 5.Castrate-Sensitive Prostate Cancer: Second-Line Therapy

EP: 6.Castrate-Sensitive Prostate Cancer: Monitoring Response to Therapy

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EP: 7.Castrate-Sensitive Prostate Cancer: TITAN Trial Outcomes

EP: 8.Treatment Advances in Castrate-Sensitive Prostate Cancer

Nicholas Vogelzang, MD, FASCO, FACP: This study [TITAN] was a large trial, over 1000 patients were randomized to either leuprolide or leuprolide with apalutamide. It allowed patients to receive docetaxel; about 17% of patients received leuprolide and docetaxel before being randomized to apalutamide. It was a striking positive result. The patients given apalutamide had a significantly superior outcome. You cannot compare across trials to LATITUDE, STAMPEDE, GETUG, and the XTANDI trials, but it certainly had that same general improvement in outcome. The PFS [progression-free survival] and objective response rates all favored the apalutamide arm by a significant amount. It led to the FDA’s approval of apalutamide.

What I thought was probably most interesting was that there was no decrement in the quality of life in the apalutamide arm compared to the leuprolide-alone arm. It was essentially negative; it was a wash. You could not see any decrease in quality of life with the addition of the androgen receptor drug. The secondary end points of time to chemotherapy, secondary treatments all favored the apalutamide arm. There was nothing in the study that was favoring leuprolide alone. I was a little disappointed that docetaxel did not do more. I am being an old-fashioned chemotherapy doctor, of course, when I say that, but nonetheless, it was not powered to look at the docetaxel arm.

In general, it would lend a lot of credibility to apalutamide being an agent that should be given in addition to leuprolide in these settings. You could argue that apalutamide would not have significant degrees of [adverse] effects. There were some: there was a low rate of seizures, with apalutamide being similar but not identical to enzalutamide. There were some falls and some fatigue, but the rates are modest as stated in the paper.

Transcript edited for clarity.

Case: A 76-Year-Old Male With Recurrent Castrate-Sensitive Prostate Cancer

History

• A 76-year-old man diagnosed with localized prostate cancer, 4 years ago
• At that time, he underwent EBRT

Currently

• Patient was lost to follow-up; returns due to intermittent hip pain
• PMH: obese, BMI 32; prostate cancer; otherwise unremarkable
• FH: No known family history of cancer
• PE: left hip tender to palpation, slight limp and evidence of decreased weight bearing on left lower limb
  
  

Clinical workup

• PSA 10 ng/mL; doubling time 3 months
• Core needle biopsy with TRUS showed adenocarcinoma of prostate
  • Gleason score (4+4)
  • Bone scan revealed 2 bone metastases: 1 in the left femur 1 in the left pelvis
• Chest/abdominal/pelvic CT scan positive for 4 pelvic lymph node metastases
• Diagnosis: stage IV mCSPC
• ECOG PS 1
   

Treatment and Follow-Up

• He was started on ADT + apalutimide 240 mg qDay
• At 3-month follow up: PSA 2 ng/mL
• Repeat imaging showed no new lesions