[Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant P… (NCT06229366) | Clinical Trial Compass
Active — Not RecruitingPhase 1
[Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer
Canada142 participantsStarted 2024-04-03
Plain-language summary
ACCEL is a multicenter, open label phase Ia/Ib/II study of \[Ac-225\]-PSMA-62 in participants with prostate-specific membrane antigen (PSMA)-positive prostate cancer.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate
✓. ECOG performance status 0 to 1
✓. Criteria specific for patients with mCRPC:
✓. Previously received an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy (unless ineligible or refused taxane). Received a maximum of 3 prior systemic therapy regimens in the mCRPC setting
✓. Progressive mCRPC at the time of consent based on at least 1 of the following criteria being met in the context of castrate levels of testosterone:
✓. At least one PSMA-PET positive lesion for prostate cancer
✓. Castrate circulating testosterone levels (\<1.74 nmol/L or \<50 ng/dL)
✓. Criteria specific for patients with OmHSPC:
Exclusion criteria
✕. Patient has received any other investigational therapeutic agents within 4 weeks or 5 half-lives (whichever is shorter) of starting the study treatment
✕. Evidence of ongoing and untreated urinary tract obstruction
✕. Existing Grade 1 dry mouth (xerostomia) or symptomatic Grade 1 dry eye (xerophthalmia) for any reason
✕. Patient has any concurrent severe and/or uncontrolled medical conditions that could increase the patient's risk for toxicity while on the study or that could confound discrimination between disease- and study treatment-related toxicities
What they're measuring
1
Maximum tolerated dose (MTD)
Timeframe: From first dose of study drug through end of DLT period (4 weeks)
2
Safety, tolerability, and Recommended Phase II Dose (RP2D)
Timeframe: From first dose of study drug through end of treatment (~16 - 24 weeks)
3
Safety and tolerability
Timeframe: From first dose of study drug through end of treatment (~16 - 24 weeks)
✕. Patient has received any PSMA-directed radioligand therapy (e.g., Lu-177-PSMA, Lu-177-PNT2002, Ac-225-J591)
✕. Patient has received any therapeutic systemic radionuclides (e.g., radium-223, rhenium-186, strontium-89), or non-PSMA-directed therapeutic radioligands (e.g., Lu-177-Dotatate) within 5 half-lives of starting the study treatment