Do not index
Do not index
Quick tags:
- Sponsor:
Novartis Pharmaceuticals
- Indication:
Prostate Cancer (PSMA-positive oligometastatic)
- Specialty:
Urology / Oncology
- Type:
Drug (Radioligand therapy)
- EHR:
Athenahealth
Trial Description
The Phase III PSMA-DC study (NCT05939414) is an international, randomized, open-label trial comparing Lutetium (177Lu) vipivotide tetraxetan (AAA617) versus observation in adult male patients with PSMA-positive oligometastatic prostate cancer (OMPC). The study is sponsored by Novartis Pharmaceuticals and aims to enroll 450 patients across 100+ sites worldwide.
Lutetium (177Lu) vipivotide tetraxetan is a PSMA-targeted radioligand therapy — a precision treatment that delivers radiation directly to PSMA-expressing cancer cells. Patients in the treatment arm receive up to 4 cycles of the therapy following stereotactic body radiation therapy (SBRT) to metastatic lesions. The primary endpoint is metastasis-free survival (MFS), measuring the time from randomization to first evidence of distant metastasis or death.
“Pluvicto, a radioligand therapy, delivers treatment directly to target cells, to change how we treat metastatic prostate cancer”
Shreeram Aradhye, President, Development and Chief Medical Officer, Novartis.
Clinic Description
Oregon Urology Institute (OUI) is a urology practice with 29 providers serving patients across Oregon. In addition to comprehensive urological care, OUI operates an active clinical research program, participating in trials across oncology and urological conditions. Victoria Evans, Director of Clinical Research, oversees the research operations.
Challenge
Oregon Urology Institute was participating as an investigative site for the Novartis PSMA-DC trial. They had been searching for eligible patients for two years — and had enrolled zero patients.
The problem wasn't a lack of effort. Victoria Evans and her team had been prescreening patients through their Athenahealth EMR and PPS Analytics, manually reviewing charts to find candidates for this complex oncology trial. They found some potential patients, but none were perfect — they all screen failed. Some had visceral metastases that the team didn't know about until deeper chart review. Others simply weren't a good fit once the full 24-point eligibility criteria were applied.
The study's inclusion and exclusion criteria were exceptionally complex. Patients must have histologically confirmed prostate cancer with biochemically recurrent disease, PSMA-positive oligometastatic disease with 1-5 metastatic lesions, and non-castration testosterone levels above 100 ng/dL. They could not have received prior androgen deprivation therapy for metastatic disease, prior radiopharmaceutical agents, or immunotherapy. Each patient's eligibility depended on 24 distinct inclusion and exclusion criteria — spanning lab results, imaging reports, pathology findings, medication history, and clinical notes.
With 29 providers across the practice, it was impossible for physicians to memorize the trial's eligibility criteria and refer patients to research. The EMR's native reporting tools could surface broad populations — patients with a prostate cancer diagnosis, for example — but lacked the precision to apply the trial's complex multi-criteria logic across structured and unstructured clinical data. Even PPS Analytics, OUI's specialty-focused care navigation solution, couldn't identify patients who met the full set of eligibility requirements.
"We had been prescreening through our EMR for two years and could not find eligible patients for this trial. It's a very complicated oncology study — we found some candidates, but none were perfect. They all screen failed. I honestly did not think anyone would be able to find patients for us."
Victoria Evans, Director of Clinical Research, Oregon Urology Institute
Solution
Oregon Urology Institute selected HealthKey to accelerate their clinical trial recruitment, choosing the PSMA-DC study as their pilot trial. Victoria Evans was skeptical — after two years of searching, she didn't expect anyone could find eligible patients that her team had missed.
HealthKey connected to OUI's Athenahealth EHR system within two weeks. Once connected, HealthKey's platform ingested 5.2 million medical records across the 5,360 prostate cancer patients — including 652,000 clinical documents/PDFs.
HealthKey's AI translated the trial's 24 inclusion and exclusion criteria into logic that could be applied across both structured fields and unstructured clinical notes. The system performed 21,115 individual criteria evaluations, automatically surfacing the 6 patients who met all eligibility requirements, along with 42 more who were near matches. Each match included direct links to the supporting evidence — the PSA levels confirming biochemical recurrence, the imaging reports documenting PSMA-positive lesions, the medication history verifying no prior ADT for metastatic disease.
The eligible patients had been in OUI's system for a long time. The critical details that confirmed their eligibility — metastatic lesion counts documented in radiology notes, disease staging buried in pathology reports — were invisible to manual review at scale. HealthKey's AI surfaced what had been there all along.
"The patients had been in our system for years — your AI found the lesions in the notes. That's something we never could have caught manually across thousands of charts."
Victoria Evans, Director of Clinical Research, Oregon Urology Institute
Patients who were close but required human judgment were flagged separately, so coordinators could focus their time on nuanced cases rather than wading through thousands of charts that clearly didn't qualify.
The Results
5,360 patients and 5.2 million medical records processed.
For OUI's clinical research team, manually reviewing this volume of patients would have required approximately 1,608 hours — over 201 full working days. HealthKey completed the analysis and surfaced eligible patients within days.
48 patients identified, 3 consented, 1 enrolled (Enrollment target = 1)
After two years with zero enrollments, OUI consented their first patients within days of receiving the matched list. The first patient has already been dosed and completed their PLUVICTO treatment cycle. Two additional patients are currently in screening. The study was eventually paused after hitting enrollment goals.
"The first few patients that came through consented, and the first one has already been dosed and finished PLUVICTO. We're still following the other two in screening. After two years of finding nothing, I didn't think this was possible."
Victoria Evans, Director of Clinical Research, Oregon Urology Institute
Novartis noticed immediately. After two years of silence from the site, OUI was suddenly enrolling patients — and the sponsor wanted to know what changed.
"I'm the CRA for Oregon Urology Institute. They all of a sudden started recruiting patients for this trial — that got me and Maurice excited. That's when Victoria told us about HealthKey."
Peter Hanna, Clinical Research Associate, Novartis
Sponsor-funded, zero net cost to OUI.
Oregon Urology Institute included HealthKey in their Novartis trial budget as a pass-through expense. Novartis approved the budget, making HealthKey's fees a sponsor-covered cost. OUI gained the enrollment results without absorbing any additional expense.
Looking Ahead
With the PSMA-DC study paused after meeting enrollment goals, Oregon Urology Institute has made HealthKey a core part of their clinical research strategy.
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