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Prostate CancerPhase 1ACCELNCT06229366

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

A Phase 1 study testing [Ac-225]-PSMA-62 (mCRPC) and [Ac-225]-PSMA-62 (OmHSPC) in people with Prostate Cancer and Metastatic Castration-resistant Prostate Cancer, run by Eli Lilly and Company at 7 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
[Ac-225]-PSMA-62 (mCRPC) and [Ac-225]-PSMA-62 (OmHSPC)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
7 sitesCanada
Study dates
3 Apr 2024to Dec 2032
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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
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  • 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
  • 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:
  • 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
  • 1- 5 PSMA-PET positive lesions identified outside the prostate bed or remaining gland.

Who cannot join

  • 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
  • Criteria specific for patients with mCRPC:
  • Patient has received any PSMA-directed radioligand therapy (e.g., Lu-177-PSMA, Lu-177-PNT2002, Ac-225-J591)
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  • 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
  • Criteria specific for patients with OmHSPC:
  • Patient has received any systemic anti-cancer therapy for prostate cancer with the exception of (neo)adjuvant ADT for management of localized disease
  • Presence of any liver metastases
  • Known presence of central nervous system metastases

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites

  • Juravinski

    Hamilton, L8V 5C2

  • Jewish General Hospital

    Montreal, H3T 1E2

  • McGill University

    Montreal, H4A 3J1

  • Centre Hospitalier Universite de QUEBEC

    Québec, G1J 1Z4

  • Hopital De Chicoutimi

    Saguenay, G7H 5H6

  • Princess Margaret Cancer Centre

    Toronto, M5G 2M9

  • BC Cancer Vancouver

    Vancouver, V5Z4E6

Other trials in Canada

About this study

Official title: [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.

Read the 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.

Being tested
[Ac-225]-PSMA-62 (mCRPC), [Ac-225]-PSMA-62 (OmHSPC)
Keywords
mCRPC, OmHSPC, Prostatic Neoplasms, Genital Neoplasms, Male, Castration Resistant Prostate Cancer, Hormone Sensitive Prostate Cancer, Oligometastatic Prostate Cancer, [225Ac]-PSMA-62, Ac-225-PSMA-62, Actinium, Radioligand Therapy, Radiopharmaceuticals, Urogenital Neoplasm
Medical subject headings
Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [Ac-225]-PSMA-62 (mCRPC)Drug

    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)Drug

    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.

Study groups in NCT06229366
Study groupRoleWhat they receive
OmHSPCExperimentalPatients 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.
Receives: Drug: [Ac-225]-PSMA-62 (OmHSPC)
mCRPCExperimentalPatients 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.
Receives: Drug: [Ac-225]-PSMA-62 (mCRPC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD)

    Phase Ia: Incidence of dose limiting toxicities (DLTs)

    Measured: From first dose of study drug through end of DLT period (4 weeks)

  2. Safety, tolerability, and Recommended Phase II Dose (RP2D)

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

    Measured: From first dose of study drug through end of treatment (~16 - 24 weeks)

  3. Safety and tolerability

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

    Measured: From first dose of study drug through end of treatment (~16 - 24 weeks)

Secondary outcomes (8)

  1. The incidence of treatment emergent adverse events as assessed per CTCAE v5.0

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

    Measured: From first dose of study drug through end of study (~5 years)

  2. Time to initiation of any life-long ADT, or other systemic hormonal therapies for prostate cancer

    OmHSPC only: Preliminary efficacy assessment

    Measured: From first dose of study drug through end of study (~5 years)

  3. Absorbed dose estimates (Gy) in normal organs

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

    Measured: From first dose of study drug through end of treatment (~16 - 24 weeks)

  4. The proportion of patients with a PSA change from baseline

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

    Measured: From first dose of study drug through efficacy follow-up period (up to approximately 3 years)

  5. Objective Response Rate (ORR)

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

    Measured: From first dose of study drug until disease progression (up to approximately 3 years)

  6. Radiographic progression free survival (rPFS)

    Phase Ib mCRPC only: rPFS per investigator assessment

    Measured: From first dose of study drug until disease progression (up to approximately 3 years)

  7. Patient Reported Outcome (PRO) - Pain

    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.

    Measured: From first dose of study drug until disease progression (up to approximately 3 years)

  8. Patient Reported Outcome (PRO) - Impact of treatment toxicity

    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.

    Measured: From first dose of study drug until disease progression (up to approximately 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2024
  2. Study start3 Apr 2024
  3. Primary completionSep 2027 (estimated)
  4. Study completionDec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
142 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06229366
Sponsor's protocol ID
27197
Other IDs
J5N-OX-JJEA
Acronym
ACCEL
Status last verified
Oct 2026
First submitted
3 Jan 2024
Last updated
6 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [Ac-225]-PSMA-62 (mCRPC) and [Ac-225]-PSMA-62 (OmHSPC) in people with Prostate Cancer and Metastatic Castration-resistant Prostate Cancer, run by Eli Lilly and Company at 7 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (time frame: From first dose of study drug through end of DLT period (4 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06229366.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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ACCEL Clinical Trial NCT06229366 | AzTrials