[177Lu]Lu-PSMA-617 in patients with PSMA-positive metastatic androgen pathway modulator-naive/sensitive prostate cancer (PSMAddition): a phase 3 randomised, controlled trial

Per the FDA label and the trials. Patient selection by PSMA PET (centrally read in the trials). Only one 20% dose reduction, to 5.9 GBq (160 mCi), is allowed, and re-escalation is not permitted; if a second reduction is needed, discontinue; if a treatment delay due to an adverse reaction lasts more than 4 weeks, consider permanent discontinuation. Complete blood count and creatinine/creatinine clearance before and during treatment; withhold for creatinine clearance below 30 mL/min. The patient should drink plenty of water and urinate frequently before and after the infusion. Dry mouth is the most common adverse reaction. To be administered only by a physician licensed to use radiopharmaceuticals.

Flush the catheter before the injection with at least 10 mL of 0.9% sodium chloride. Only dose-reduction level: 20%, to 5.9 GBq (160 mCi); do not re-escalate; if a second reduction or a delay of more than 4 weeks is needed: discontinue. Grade 2 bone marrow suppression: withhold until grade 1; grade 3 or higher: withhold and reduce the dose; recurrence after reduction: discontinue. Renal toxicity (grade 2 creatinine increase or CLcr below 30): withhold until improvement; creatinine increase of 40% or more and CLcr decrease of more than 40%: withhold and reduce the dose; grade 3 or higher: discontinue. Grade 3 dry mouth or grade 3 or higher gastrointestinal toxicity refractory to treatment: withhold and reduce the dose. Monitor CBC and creatinine/CLcr before and during treatment; good hydration and frequent voiding before and after the injection; follow radiation protection principles; the partner should avoid pregnancy until 14 weeks after the last dose. In PSMAddition, the ADT + ARPI was chosen by the physician.