On Target · Issue 16•Week Ending November 6, 2026
Give Every Lu-177 PSMA Patient a Written Discharge Template
PSMA PET & Theranostics IntelligenceRadiation Safety16 primary sources
Editor’s Spotlight
A JNM survey of 102 centers in 23 countries found broad consensus on core Lu-177 PSMA treatment procedures, but wide variation in post-therapy radiation-safety instructions: recommended distancing ranged from 1 to 7 days, and 20% of outpatient centers gave no formal distance guidance at all. That lands in a week of real commercial progress — Clarity finished enrolling two registrational Phase III trials, Telix reaffirmed FY2026 guidance at its Capital Markets Day, and GE HealthCare agreed to pay $945 million to build out U.S. PET radiopharmaceutical supply. Reliability is becoming as important as the pipeline.
Story of the Week
A JNM survey of 102 centers in 23 countries found broad agreement on pretreatment and most posttreatment procedures for Lu-177 PSMA radioligand therapy, but real variability in radiation precautions after discharge. Outpatient centers’ recommended distance-from-others guidance ranged from 1 to 7 days, recommended separation distances ranged from 1 to 3 meters, and 20% of outpatient centers gave no formal distance guidance at all. The authors, who developed a structured patient-information template as part of the study, concluded the field has consensus on clinical procedure but not on how it communicates radiation safety to patients and caregivers.
Clinical News
A Stanford-led study of 158 men on 177Lu-PSMA-617 therapy found that early same-day SPECT/CT response assessed by visual RECIP 1.0 after treatment cycle 2 was associated with overall survival: a median of 21.5 months for responders versus 11.3 months for non-responders (P<0.001). Combining imaging response with baseline tumor volume and PSA50 improved risk stratification further.
An Oregon Health & Science University-led study of 50 men with biochemical recurrence and a negative PSMA PET scan found fluciclovine PET positive in 28 patients (56%), split evenly between prostate-bed-only and nodal or distant disease. Intended management changed in 71% of patients overall.
France’s PSMA-REACH cohort, a retrospective chart review of 439 heavily pretreated mCRPC patients across 26 French sites, reported at ESMO 2026 a median overall survival of 13.1 months on 177Lu-PSMA-617 in routine clinical practice, with no new safety signal. Median OS was 15.8 months with one prior taxane versus 11.3 months with two or more.
Business & Industry Intelligence
Clarity Pharmaceuticals’ registrational Phase III CLARIFY trial has dosed its full target of 383 participants; companion trial AMPLIFY, in the biochemical-recurrence setting, is also fully enrolled. Topline data for both are expected in the first half of 2027 to support an FDA filing for 64Cu-SAR-bisPSMA.
At its November 4 Capital Markets Day, Telix reaffirmed FY2026 revenue guidance of $950 to $970 million, first issued in February and reaffirmed again in its October 21 Q3 release, and said it expects a positive EBITDA contribution starting in 2027; the company gave no FY2027 revenue figure. Its pending acquisition of ITM, projected at roughly $300 million of 2026 revenue, is expected to close in FY2026 subject to shareholder and regulatory approval, with about $50 million of targeted synergies over the first two years.
GE HealthCare posted Q3 2026 revenue of $5.5 billion, up 7.2% year over year, with its Pharmaceutical Diagnostics segment growing 13% to $846 million and leading all three business lines. Net income rose 37.9% to $615 million.
Clinical Trials to Watch
Clarity Pharmaceuticals / CLARIFY (64Cu-SAR-bisPSMA) — registrational Phase III fully enrolled at 383 participants; topline data expected H1 2027.
Clarity Pharmaceuticals / AMPLIFY (64Cu-SAR-bisPSMA) — companion registrational Phase III in biochemical recurrence, also fully enrolled; data expected alongside CLARIFY.
Telix / ProstACT Global (TLX591-Tx) — Part 2 enrolling across Australia, New Zealand, Canada, Turkiye, and the UK; U.S. initiation is pending an IND amendment Telix is finalizing after Part 1 safety data cleared the way to proceed.
AdvanCell / ADVC001 (212Pb-PSMA) — Phase 1 TheraPb data presented at ESMO 2026 showed 80% of patients had a PSA decline of at least 50% at recommended doses, with 14.1-month median follow-up.
Industry Movers & News in Brief
GE HealthCare agreed to acquire Sofie Biosciences for $945 million to build out its U.S. PET radiopharmaceutical supply footprint; the deal is expected to close in the first half of 2027.
Elsewhere, a JNM brief communication quantified real-world PSMA PET/CT and 177Lu-PSMA access gaps between Brazil and Europe, and a JNM letter disputes the true U.S. acquisition cost of 177Lu-PSMA-617 against cabazitaxel in cost-effectiveness models.
The Lantheus-Curium merger has drawn an FTC Second Request, with both companies continuing to expect the deal to close in the first half of 2027.
Upcoming events: RSNA 2026 November 29–December 3, Chicago, IL; SUO 2026 Annual Meeting December 2–4, San Diego, CA; the SNMMI Mid-Winter Meeting February 4–6, 2027, San Francisco, CA; and ASCO GU Cancers Symposium 2027 February 11–13, 2027, San Francisco, CA.
This newsletter is for informational and educational purposes only and does not constitute medical, legal, investment, or reimbursement advice. Readers should consult their own professional advisors for specific guidance.


