Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06229366

Active, not recruiting

ACCEL: [Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer

Interventional

Phase 1

Princess Margaret Cancer Centre

Sponsor: Eli Lilly and Company

Last Updated: September 24, 2025
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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.

Show Detailed Description

Treatment Category

Radiopharmaceuticals

Required Mutations

None

Trial Started

April 3, 2024

Last Updated by Sponsor

September 24, 2025

Estimated Completion

September 1, 2027

Contact Study

Name:Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Email:LillyTrials@Lilly.com

Phone:1-317-615-4559

Name:Physicians interested in becoming principal investigators please contact

Email:clinical_inquiry_hub@lilly.com

Eligibility

Inclusion Criteria

1. Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate

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

1. Patient has received any other investigational therapeutic agents within 4 weeks or 5 half-lives (whichever is shorter) of starting the study treatment

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

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Design Details

AllocationNon-Randomized

Intervention ModelParallel Assignment

MaskingNone (Open Label)

Number to Enroll142

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: 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.

Interventions:

[Ac-225]-PSMA-62 (mCRPC)
[Ac-225]-PSMA-62 (OmHSPC)

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose (MTD)From first dose of study drug through end of DLT period (4 weeks)

Phase Ia: Incidence of dose limiting toxicities (DLTs)

Safety, tolerability, and Recommended Phase II Dose (RP2D)From first dose of study drug through end of treatment (~16 - 24 weeks)

Phase 1b: Incidence and severity of treatment emergent adverse events (TEAEs)

Safety and tolerabilityFrom first dose of study drug through end of treatment (~16 - 24 weeks)

Phase Ia: Incidence and severity of treatment emergent adverse events (TEAEs)

Secondary Outcome Measures

The incidence of treatment emergent adverse events as assessed per CTCAE v5.0From first dose of study drug through end of study (~5 years)

To assess safety and tolerability of [Ac-225]-PSMA-62

Absorbed dose estimates (Gy) in normal organsFrom first dose of study drug through end of treatment (~16 - 24 weeks)

Evaluation of the biodistribution and radiation dosimetry of [Ac-225]-PSMA-62 to normal organs

The proportion of patients with a PSA change from baselineFrom first dose of study drug through efficacy follow-up period (up to approximately 3 years)

To determine the effect of [Ac-225]-PSMA-62 on prostate-specific antigen (PSA) kinetics

Time to initiation of any life-long ADT, or other systemic hormonal therapies for prostate cancerFrom first dose of study drug through end of study (~5 years)

OmHSPC only: Preliminary efficacy assessment

Objective Response Rate (ORR)From first dose of study drug until disease progression (up to approximately 3 years)

mCRPC only: Percentage of participants with a complete response (CR) or partial response (PR)

Radiographic progression free survival (rPFS)From first dose of study drug until disease progression (up to approximately 3 years)

Phase Ib mCRPC only: rPFS per investigator assessment

Patient Reported Outcome (PRO) - PainFrom first dose of study drug until disease progression (up to approximately 3 years)

Phase Ib only: Measured by the change on the Brief Pain Inventory Short Form (BPI-SF) questionnaire, scored from 0 ('No pain', 'Does not interfere') to 10 ('Pain as bad as you can imagine', 'Completely interferes') on the severity and interference on daily functions of pain.

Patient Reported Outcome (PRO) - Impact of treatment toxicityFrom first dose of study drug until disease progression (up to approximately 3 years)

Phase Ib only: Measured by the change the Functional Assessment of Cancer Therapy (FACT-Item GP5) questionnaire, scored from 0 ('Not at all') to 4 ('Very much') on the interference of symptoms related to treatment emergent adverse events.

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Trial Sites

This study has 7 trial sites

Princess Margaret Cancer Centre

Toronto, CA

Name:Di Jiang

Recruiting

Toronto, M5G 2M9 CA

Princess Margaret Cancer Centre

Not yet recruiting

Montreal, H3T 1E2 CA

Jewish General Hospital

Not yet recruiting

Hamilton, L8V 5C2 CA

Juravinski

Recruiting

Montreal, H4A 3J1 CA

McGill University

Recruiting

Québec, G1J 1Z4 CA

Centre Hospitalier Universite de QUEBEC

Not yet recruiting

Saguenay, G7H 5H6 CA

Hopital De Chicoutimi

Recruiting

Vancouver, V5Z4E6 CA

BC Cancer Vancouver

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