Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06855277 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.
MinorTrial sites expanded: 95 → 100 locationsEligibility criteria expanded, about 12 words · Secondary endpoints: details revised at 4 of 15 entries · Study description revisedShow 3 more changesShow less
Eligibility criteria expanded, about 12 words
Secondary endpoints: details revised at 4 of 15 entries
Study description revised
MinorStudy sites: 93 to 95v22
MinorStudy sites: 92 to 93v21
MinorTrial sites expanded: 88 → 92 locationsv20
MinorTrial sites expanded: 70 → 88 locationsv19
MinorTrial sites expanded: 55 → 69 locationsv18
MinorStudy sites: 55 to 69v17
MinorStudy sites: 50 to 55v16
NotablePrimary completion date: Feb 29, 2028 to Sep 29, 2028Study sites: 44 to 50v15Show 1 more changeShow less
Study sites: 44 to 50
MinorStudy sites: 37 to 44Primary completion date: Sep 29, 2028 to Feb 29, 2028v14Show 1 more changeShow less
Primary completion date: Sep 29, 2028 to Feb 29, 2028
NotableEnrollment target: 605 to 940Primary completion date: Feb 29, 2028 to Sep 29, 2028 · Study sites: 29 to 37 · Eligibility criteria expanded, about 19 words · 2 morev13Show 5 more changesShow less
Primary completion date: Feb 29, 2028 to Sep 29, 2028
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 0 to 5 · Start date changed from estimate of Aug 20, 2025 to Jul 1, 2025v4Show 2 more changesShow less
Study sites: 0 to 5
Start date changed from estimate of Aug 20, 2025 to Jul 1, 2025
MinorEnrollment target: 486 to 605Primary completion date: Dec 31, 2027 to Feb 29, 2028v3Show 1 more changeShow less
Primary completion date: Dec 31, 2027 to Feb 29, 2028
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to determine whether \[225Ac\]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or \[177Lu\]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.