1. ¹⁷⁷Lu vipivotide tetraxetan (Pluvicto) - PMSA-617
   1. Background
      1. Over 90% of prostate cancers have PSMA overly expressed which includes metastatic disease. Usually have a high Gleason score
      2. PMSA can be tagged to ¹⁸F, ⁶⁸Ga, ^99mTc, ¹⁷⁷Lu, ²²⁵Ac, ¹¹¹In, and ⁹⁰Y, and there are others
   2. to PLUVICTO therapy
      1. (1 to 2) texane-based chemotherapy on metastatic castration-resistant prostate cancer (mCRPC) should have been attempted
      2. Patient must have at least one positive PSMA+ site
2. Mechanism of Action - Link to manufacturer's website

1. This is a PSMA biomaker which seeks out PSMA sites on prostate cancer cells
2. Attaching to the cell it then releases β^-
3. These particles damage the DNA preventing replication
4. Candidates for this procedure include mCRPC who no longer respond to treatment.
5. >80% of men that have prostate cancer are PMSA+
1. Radiation risk
   1. Exposure is associated with increased risk of cancer
   2. Follow radiation safety procedures for NMTs and family members - remember the 100 and 500 mrem rule?
      1. In general limit family members exposure for at least 2 days
         1. Children 7 days
         2. Sexual activity 7 days
         3. Suggest separate bedrooms and bathrooms for at least 3 days, children 7 days, pregnant women 15 days.
   3. Increase oral fluids to reduce radiation exposure
2. Myelosuppression
   1. Decrease in leukocytes, platelets, and neutrophils will occur
   2. Monitor patient while under treatment
   3. >30% of patients had reduced lymphocytes, hemoglobin, leukocytes, platelets. Along with reduced calcium and sodium levels
3. Renal Toxicity
   1. Clinical trials found 3% having acute kidney injury
   2. Elevation of creatinine occurred
   3. Keep the patient well hydrated
   4. Monitor renal function
   5. In certain cases reduced dose or discontinuing the procedure may occur
4. A cumulative dose of 44.4 GBq of Pluvicto may cause temporary or permanent infertility
5. Adverse reaction occurred 20% in clinical trials and they included - fatigue, dry mouth, nausea, anemia, reduced appetite, and constipation.
6. Administration of therapy

   
   1. Dose arrives in a 30 mL vial that can be expanded to 12.5mL
   2. Two hundred mCi is given every 6 weeks, IV with an infusion that should take between 1 and 10 minutes
   3. Dose should then be flushed with at least 10 mL of saline
   4. Dosing can be done via the gravity method (refer to ¹⁷⁷Lu-DODATATE - CLRS 417 lecture)
   5. See Dosing and Administration Guide for more details
7. Results
   1. Forty-six percent who received PLUVICTO and a >50% decline in their PSA level
   2. Survival
      1. Best Standard of Care (BSOC) - application of taxane therapy has a median survival of 11.8 months (unknown - does one treatment require a series of doses?)
      2. BSOC (one treatment) and Pluvicto median survival 16.2 months
      3. Second treatment of just BSOC or BSOC followed by Pluvicto median survival decreases
      4. Literature states a gain of 4 months life expectancy vs just applying Best Standard of Care (BSOC)
      5. For more information visit Efficacy of Pluvicto

For more information visit the Pluvicto website