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

December 19, 2025 updated by: Eli Lilly and Company

[Ac-225]-PSMA-62 Phase I/II Clinical Trial to Characterize Efficacy, Safety, Tolerability, and Dosimetry in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer (ACCEL)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary aim of the phase Ia study is to evaluate the safety and tolerability of [Ac-225]-PSMA-62 to determine the maximum tolerated dose (MTD). The primary aim of the randomized phase Ib dose optimization is to determine the recommended phase II doses (RP2D) for patients with mCRPC and OmHSPC. The aim of the phase II study for patients with mCRPC is to evaluate the efficacy of [Ac-225]-PSMA-62.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
142

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Canada
      • Hamilton, Canada, L8V 5C2
        • Juravinski
      • Montreal, Canada, H3T 1E2
        • Jewish General Hospital
      • Montreal, Canada, H4A 3J1
        • McGill University
      • Québec, Canada, G1J 1Z4
        • Centre Hospitalier Universite de QUEBEC
      • Saguenay, Canada, G7H 5H6
        • Hopital de Chicoutimi
      • Toronto, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
      • Vancouver, Canada, V5Z4E6
        • BC Cancer Vancouver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: [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.
Experimental: 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.
Drug: [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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose (MTD)
Time Frame: From first dose of study drug through end of DLT period (4 weeks)
Phase Ia: Incidence of dose limiting toxicities (DLTs)
From first dose of study drug through end of DLT period (4 weeks)
Safety, tolerability, and Recommended Phase II Dose (RP2D)
Time Frame: From first dose of study drug through end of treatment (~16 - 24 weeks)
Phase 1b: Incidence and severity of treatment emergent adverse events (TEAEs)
From first dose of study drug through end of treatment (~16 - 24 weeks)
Safety and tolerability
Time Frame: From first dose of study drug through end of treatment (~16 - 24 weeks)
Phase Ia: Incidence and severity of treatment emergent adverse events (TEAEs)
From first dose of study drug through end of treatment (~16 - 24 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence of treatment emergent adverse events as assessed per CTCAE v5.0
Time Frame: From first dose of study drug through end of study (~5 years)
To assess safety and tolerability of [Ac-225]-PSMA-62
From first dose of study drug through end of study (~5 years)
Absorbed dose estimates (Gy) in normal organs
Time Frame: From 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
From first dose of study drug through end of treatment (~16 - 24 weeks)
The proportion of patients with a PSA change from baseline
Time Frame: From 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
From first dose of study drug through efficacy follow-up period (up to approximately 3 years)
Time to initiation of any life-long ADT, or other systemic hormonal therapies for prostate cancer
Time Frame: From first dose of study drug through end of study (~5 years)
OmHSPC only: Preliminary efficacy assessment
From first dose of study drug through end of study (~5 years)
Objective Response Rate (ORR)
Time Frame: 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)
From first dose of study drug until disease progression (up to approximately 3 years)
Radiographic progression free survival (rPFS)
Time Frame: From first dose of study drug until disease progression (up to approximately 3 years)
Phase Ib mCRPC only: rPFS per investigator assessment
From first dose of study drug until disease progression (up to approximately 3 years)
Patient Reported Outcome (PRO) - Pain
Time Frame: From 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.
From first dose of study drug until disease progression (up to approximately 3 years)
Patient Reported Outcome (PRO) - Impact of treatment toxicity
Time Frame: From 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.
From first dose of study drug until disease progression (up to approximately 3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: 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), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27197
  • J5N-OX-JJEA (Other Identifier: Eli Lilly and Company)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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