I want to start with an uncomfortable observation.
In conversations with oncologists and urologists across the country, I keep hearing the same thing: “I’ve been meaning to learn more about theranostics.” And then I ask how many patients they’ve referred for 177Lu-PSMA therapy, and the answer is usually small.
These aren’t providers who don’t care about their patients. They’re providers who are busy taking care of patients and working within a referral ecosystem that has never clearly explained how this particular pathway works.
The treatment exists. The FDA approved it in 2022. The phase 3 data is strong. The patients who qualify for it are sitting in waiting rooms across this region right now.
The gap between “approved and effective” and “being offered to patients in rural Appalachia” is an education and training problem. That’s the problem ARC exists to close.
This post is my attempt to give you the short version of what you need to know to start having the referral conversation. If you want the long version, full eligibility criteria, step-by-step referral pathway, documentation checklist, answers to the clinical questions that come up most, ARC is working on a full published referral pathway guide so stay tuned!
What 177Lu-PSMA Actually Is
The short version: it’s a drug that finds prostate cancer cells and hopefully kills them with targeted radiation — all using the same biological pathway.
PSMA (prostate-specific membrane antigen) is a protein that prostate cancer cells overexpress. We’ve been imaging it for staging with PSMA-PET/CT for years. What 177Lu-PSMA-617 (brand name Pluvicto) does is attach a radioactive payload to the same targeting molecule. The cancer lights up on the PET scan because it’s PSMA-avid. The therapy works for the same reason.
This is what makes theranostics conceptually elegant and practically powerful: the imaging doesn’t just stage the disease. It tells you whether the therapy has something to shoot at before you commit to treatment. If the PSMA-PET shows high expression across all sites, you have strong reason to expect the therapy will find its target. If it doesn’t, or if there are PSMA-negative lesions, that’s critical information too.
The Core Eligibility Question
The FDA approval is based on the VISION trial. The target population is patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on at least one androgen receptor pathway inhibitor (enzalutamide, apalutamide, darolutamide, or abiraterone) and at least one taxane-based regimen (or who are ineligible for taxane chemotherapy).
It is worth reading that again: prior ARPI and prior taxane therapy are prerequisites, not disqualifiers. The patients who have already been through those treatments and are now progressing are exactly the population this was designed for.
The other requirement is a PSMA-PET/CT showing PSMA-positive disease. If your patient has had a recent PSMA-PET and it showed strong expression, that’s already most of the eligibility work done. If they haven’t had one, that’s where the pathway starts.
Organ function matters too, with adequate renal function and bone marrow, being important. Low platelets and renal impairment are the most common reasons for delays. Recent labs are a must to send to the treating provider and we order a full CBC, CMP, and PSA test when we perform our pre-therapy labs.
ECOG status is also important as patients should be reasonably mobile. ECOG 0-2 is preferred to ensure the patient has sufficient mobility to be able to care for themselves adequately during the time they will be radioactive. Worse ECOG status potentially can be treated but should be reviewed carefully by the care team to prevent unsafe exposures to the patient and family that may be around them after therapy.
The Three Things That Actually Hold Up Referrals
After enough of these conversations, the real barriers become predictable.
The first is the mistaken belief that being post-taxane means the patient is too sick or too far along. It means the opposite. That’s the population the trial enrolled. If your patient has been through ARPI and chemotherapy and is now progressing, the eligibility conversation is appropriate. Anecdotally, we find that the earlier in the process we start 177Lu-PSMA-617, the better the experience for the patient.
The second is not knowing who to call. This is the most legitimate barrier in community settings, and I’ll be direct: the referral pathway for theranostics is not typically as standardized as sending someone for radiation or a surgical consult. For providers in the Knoxville-to-Roanoke corridor, UT Medical Center and Carilion Clinic both have operational theranostics programs that have treated hundreds of patients. If you’re not sure who to contact, reach out through arctheranostics.org and we’ll help navigate it.
The third is concern that the patient won’t travel. This is real in Appalachia. I’m not going to pretend distance isn’t a barrier. But some patients, when they understand what the treatment is and what the data shows, will make the trip. The ones who won’t travel, deserve to make that choice themselves after hearing all of the details. For our patients, we spend 1-2 hours in the consult with the patient making sure they have all the information they need to make an informed decision on whether the therapy is right for them and their family.
What’s not acceptable is the option never being offered simply due to lack of perceived access. Building more community-based sites with trained staff, which is what ARC is working on, is how we reduce the distance problem over time.
What the Referral Actually Looks Like
- Order a PSMA-PET/CT if not already done.
- Pull a current CBC, CMP, and baseline PSA.
- Send a referral to the appropriate theranostics team with the patient’s treatment history, PSA trend, PET result, and relevant comorbidities.
That’s the whole thing. A nuclear medicine or theranostics team takes it from there, reviewing the images directly, evaluating organ function, discussing risks, and scheduling the consultation visit if the patient is a candidate.
Treatment is outpatient IV infusion, typically every 6 weeks for up to 6 cycles. You stay involved as the primary oncologist throughout.
The most important thing you can tell your patient before referring: this is a conversation, not a commitment. The evaluation determines candidacy. Nothing is scheduled until both the clinical team and the patient have decided it’s the right path.
ARC’s regional workshops are built specifically around providing education on referral and implementation questions this post can only partially answer. If you want to work through real cases with nuclear medicine physicians and other referring providers in the same room, that’s what we’re building. Our first workshop is on April 18th, 2026 at the University of Tennessee Medical Center (registration link here).
