We report preliminary results of an open-label, single-arm clinical trial evaluating the safety and immediate oncological outcomes of 177Lu-PSMA-I&T (LuPSMA), followed by radical prostatectomy (RP) with pelvic lymph node dissection (PLND) in patients with high-risk prostate cancer (HRPCa).
Consecutive HRPCa patients with high PSMA avidity on 68Ga- PSMA PET/CT received two 7.4 GBq LuPSMA treatments 6 and 8 weeks before RP with PLND. LuPSMA side effects and surgical parameters were documented. Final surgical pathology and postoperative biochemical response were recorded. All patients completed validated health-related quality of life questionnaires at baseline and during postoperative follow-up. Seven patients were enrolled at median age was 66 years (IQR 60, 68). Four patients were Gleason grade group 4 and three were Gleason grade group 5.
The median PSA level decreased by 35% from 11.4 ng/dL (IQR 7.6, 27) at baseline to 7.4 ng/dL (IQR 2.8, 20.9) after the two LuPSMA treatments. The only reported adverse event during treatment was fatigue in 1 patient (14%). In 3 patients, periprostatic adhesions were encountered during surgery without any intraoperative complications. The median surgical length and median estimated blood loss was 230 minutes (IQR 210, 256) and 300 ml (IQR 200, 300), respectively. The median hospital stay was 3 days (IQR 2, 4) with fever in 1 patient being the only postoperative event. Treatment-related histological changes were noted in 4 of 7 final surgical specimens. Positive surgical margins were identified in 2 patients. Biochemical response was observed in all patients, with a median postoperative PSA of 0.01 ng/dL (IQR 0.01, 0.03). All patients required ≤1 pad at 3 months after surgery.
Preliminary data suggest that two LuPSMA treatments followed by RP can be safely applied to patients with locally advanced HRPCa. While longer oncological outcomes are pending, continence recovery seems to be unaffected by LuPSMA treatment.
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Neo-adjuvant 177Lu-PSMA-I&T radionuclide in high-risk prostate cancer before radical prostatectomy: a feasibility trial
Prostate Cancer > Locally Advanced
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Thursday, Dec 2
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Presented By: Michael Frumer