Dillon Cockrell, GU Medical Oncologist at Duke Cancer Institute, shared a post on LinkedIn:
“Radioligand treatment with Lu-PSMA-617 (Pluvicto) continues moving earlier in the prostate cancer treatment landscape.
The BULLSEYE trial (Lu-PSMA-617 vs deferred ADT in oligo-mHSPC) now published in Lancet Oncology provides randomized data in recurrent, oligometastatic HSPC.
Design
- Phase 2 RCT (n=58); PSMA+ oligo-mHSPC (≤5 mets, SUVmax ≥15), PSA DT <6 mo, ineligible for salvage RT or surgery.
- 2+2 cycles of Lu-PSMA-617 vs active monitoring with deferred ADT at progression.
Results
- 7% of Lu-PSMA pts progressed at 30 wks, an impressive absolute rate, though 93% control progression is expected given surveillance design.
- Med PFS 25 vs 5 mo (HR 0.07).
- PSA50 83%; complete biochemical response 24%.
- Mostly G1-2 toxicity; no serious AEs in the treatment arm, similar QOL to surveillance.
Takeaways
- Durability signal is notable. A 25-mo PFS and 24% complete biochemical responses suggest some patients may achieve lasting responses.
- Like PSMA-PET-guided SBRT, Lu-PSMA offers an approach to treat visible disease and defer ADT. Unlike SBRT, its systemic mechanism may also target occult micrometastatic disease, potentially explaining the depth and durability of response.
- Comparator is key. Deferred ADT alone is not modern SOC for high-risk BCR (EMBARK: ARPI +/- ADT) or oligo-mHSPC (ADT +/- ARPI and/or SBRT).
RLT in hormone-sensitive disease has a compelling biological rationale and ADT-free survival is a meaningful endpoint. Phase III data could support a patient-friendly, durable new option.”
Title: [177Lu]-PSMA-617-PSMA-617 in oligometastatic hormone sensitive prostate cancer (BULLSEYE): an open-label, randomised, phase 2 study
Authors: Bastiaan M Privé, Walter Noordzij, Constantijn H J Muselaers, Igle J de Jong, Inge M van Oort, Marcel J R Janssen, Maartje C van Rijk, Willemijn A van Gemert, Bart Timmermans, Michel de Groot, Niven Mehra, Winald R Gerritsen, Marianne A Jonker, Emmanouil Alevroudis, Suzanne van der Gaag, Josephina C C Koppes, J P Michiel Sedelaar, André N Vis, Alexis Vrachimis, Daniela E Oprea-Lager, James Nagarajah
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