[Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer
NCT ID: NCT06229366
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
142 participants
INTERVENTIONAL
2024-04-03
2032-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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OmHSPC
Patients with prostate cancer and biochemical recurrence after definitive surgery or radiation therapy, with 1-5 PSMA-positive lesions, who have not yet initiated lifelong hormone therapy.
[Ac-225]-PSMA-62 (OmHSPC)
Phase Ia: Administered intravenously per dose escalation scheme. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 8-week cycle for up to 2 cycles.
Phase Ib: Administered intravenously at MTD or one dose level below MTD. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 8-week cycle, for a total of 2 cycles.
mCRPC
Patients with PSMA-positive mCRPC who have prior treatment with at least one APRI and received taxane chemotherapy (or ineligible/refused); and received a maximum of 3 prior systemic therapy regimens in the mCRPC setting.
[Ac-225]-PSMA-62 (mCRPC)
Phase Ia: Administered intravenously per dose escalation scheme. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 6-week cycle for up to 4 cycles.
Phase Ib: Administered intravenously at MTD or one dose level below MTD. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 6-week or 4-week cycle, for a total of 4 cycles.
Interventions
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[Ac-225]-PSMA-62 (mCRPC)
Phase Ia: Administered intravenously per dose escalation scheme. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 6-week cycle for up to 4 cycles.
Phase Ib: Administered intravenously at MTD or one dose level below MTD. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 6-week or 4-week cycle, for a total of 4 cycles.
[Ac-225]-PSMA-62 (OmHSPC)
Phase Ia: Administered intravenously per dose escalation scheme. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 8-week cycle for up to 2 cycles.
Phase Ib: Administered intravenously at MTD or one dose level below MTD. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 8-week cycle, for a total of 2 cycles.
Eligibility Criteria
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Inclusion Criteria
2. ECOG performance status 0 to 1
3. Criteria specific for patients with mCRPC:
1. 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
2. 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:
* PSA progression defined as rising PSA values at a minimum of 1-week intervals, with the last result being at least 1.0 ng/mL
* Soft-tissue progression defined as an increase ≥20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions
* Progression of bone disease defined as the appearance of two or more new lesions by bone scan
3. At least one PSMA-PET positive lesion for prostate cancer
4. Castrate circulating testosterone levels (\<1.74 nmol/L or \<50 ng/dL)
4. Criteria specific for patients with OmHSPC:
1. PSA recurrence after radical prostatectomy (RP) or definitive radiation therapy (RT), with or without adjuvant/salvage local therapy (radiation or surgery), with or without (neo)adjuvant ADT
* PSA ≥ 0.2ng/mL for patients with prior RP +/- RT, or
* PSA of ≥ 2 ng/mL above nadir for patients with only prior RT
2. 1- 5 PSMA-PET positive lesions identified outside the prostate bed or remaining gland.
Exclusion Criteria
2. Evidence of ongoing and untreated urinary tract obstruction
3. Existing Grade 1 dry mouth (xerostomia) or symptomatic Grade 1 dry eye (xerophthalmia) for any reason
4. 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
5. Criteria specific for patients with mCRPC:
1. Patient has received any PSMA-directed radioligand therapy (e.g., Lu-177-PSMA, Lu-177-PNT2002, Ac-225-J591)
2. 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
6. Criteria specific for patients with OmHSPC:
1. Patient has received any systemic anti-cancer therapy for prostate cancer with the exception of (neo)adjuvant ADT for management of localized disease
2. Presence of any liver metastases
3. Known presence of central nervous system metastases
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Juravinski
Hamilton, , Canada
Jewish General Hospital
Montreal, , Canada
McGill University
Montreal, , Canada
Centre Hospitalier Universite de QUEBEC
Québec, , Canada
Hopital De Chicoutimi
Saguenay, , Canada
Princess Margaret Cancer Centre
Toronto, , Canada
BC Cancer Vancouver
Vancouver, , Canada
Countries
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Other Identifiers
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J5N-OX-JJEA
Identifier Type: OTHER
Identifier Source: secondary_id
27197
Identifier Type: -
Identifier Source: org_study_id