Professional Statements and Societal Positions Guidelines
The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.
Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in 'Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.
National Comprehensive Cancer Network
The National Comprehensive Cancer Network guideline for prostate cancer (v4.2022) provides the following relevant recommendations with regard to the use of lutetium Lu 177 vipivotide tetraxetan (Lu-177-PSMA-617):
'The NCCN Panel recommends Lu-177-PSMA-617 as a category 1, useful in certain circumstances treatment option for patients with 1 PSMA-positive lesion and/or metastatic disease that is predominately PSMA-positive and with no dominant PSMA-negative metastatic lesions who have been treated previously with androgen receptor-directed therapy and a taxane-based chemotherapy. PSMA-negative lesions are defined as metastatic disease that lacks PSMA uptake including bone with soft tissue components 1.0 cm, lymph nodes 2.5 cm in short axis, and solid organ metastases 1.0 cm in size. The NCCN Panel believes that both Ga-68 PSMA-11 or F-18 piflufolastat PSMA imaging can be used to determine eligibility.'
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed in Table 3.
Table 3. Summary of Key Trials
|An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination with SoC, Versus SoC Alone, in Adult Male Patients with mHSPC (PSMAddition)
|177Lu-PSMA-617 vs. Androgen Receptor-directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer (PSMAfore)
|A Randomized Phase II Study of 177 LuPSMA-617 vs Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer and PSMA-Positive Disease
|Phase II Study of Radionuclide 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With MetastaticCastration Resistant Prostate Cancer (mCRPC)
NCT: national clinical trial.
a Denotes industry-sponsored or cosponsored trial.