M.D. Anderson prostate trial reopens enrollment after March closeout
The Nautilus lutetium trial swung from Active-not-recruiting back to Recruiting four months after cutting its enrollment target from 36 to 6.
Executive Summary
- A small, single-site prostate cancer trial reopened enrollment months after appearing to close it out, reversing a status change it had made only recently.
- The reopening lands alongside an enrollment-target cut made in the same earlier update, a combination that reads as an unsettled recruitment plan rather than a routine registry edit.
- The trial's primary completion date has already been pushed back twice since it first registered, and the current target sits at the end of this year.
- The trial is designed to measure radiation dose delivered to the tumor and PSA response before surgery, a dosimetry-and-biomarker bar rather than a survival endpoint, so its readout will be hypothesis-generating for the neoadjuvant theranostic approach, not decision-grade on its own.
The status reversal
NCT06066437 shifted from Recruiting to Active, not recruiting on 2026-03-05, then reversed course back to Recruiting on 2026-07-15. The same March update cut the trial's enrollment target from 36 to 6, and the July update left that lowered target of 6 in place while restarting active recruitment. A trial that had appeared to finish enrolling and move into follow-up is instead back to signing up patients under a smaller target than it originally registered. NCT06066437NeoAdjuvant Theranostic Lutetium Study: The Nautilus TrialNCT06066437
The trial
Nautilus is a Phase 1/2, single-site study run by M.D. Anderson Cancer Center with Blue Earth Therapeutics as a collaborator, testing 177Lu rhPSMA-10.1 given before radical prostatectomy in men with high-risk or very-high-risk localized prostate adenocarcinoma. It first posted to the registry on 2023-10-04 and began recruiting on 2024-03-29. The registered primary measures are radiation dose delivered to the tumor (dosimetry) and PSA assessment, evaluated over up to six months, alongside a separate primary measure tracking adverse events graded by NCI CTCAE v5.0 through roughly one year. Those are imaging and biomarker endpoints paired with a safety readout, not a clinical-outcome bar. NCT06066437NeoAdjuvant Theranostic Lutetium Study: The Nautilus TrialNCT06066437
Timeline movement
The trial's primary completion date has moved twice on the public registry: from 2024-12-31 to 2025-06-30 in November 2023, then from 2025-06-30 to 2026-12-31 in March 2025. That is a cumulative delay of roughly 730 days from the date first registered to the date now in place. The overall study completion date sits further out, at 2027-12-31. Enrollment has also moved twice, first rising from 30 to 36 in November 2023, then falling to 6 in March 2026. NCT06066437NeoAdjuvant Theranostic Lutetium Study: The Nautilus TrialNCT06066437
Reading the pattern
Registry change events show three status transitions and two changes each to enrollment target and primary completion date since the trial was added, a change frequency the registry proxy labels moderate at roughly 1.7 changes per year. Re-entering Recruiting from Active, not recruiting is not the pattern of a trial that filled to target and moved cleanly into follow-up; combined with the enrollment cut to 6, it points to a recruitment plan still being adjusted rather than one that closed on schedule. M.D. Anderson's own portfolio completes at a 70% rate across 511 tracked trials, a base rate for the sponsor generally rather than a signal specific to this program. NCT06066437NeoAdjuvant Theranostic Lutetium Study: The Nautilus TrialNCT06066437
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