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Radioisotope Therapy

[Ac-225]-PSMA-62 for Prostate Cancer (ACCEL Trial)

Phase 1

Recruiting

Research Sponsored by POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Progressive mCRPC at the time of consent based on at least 1 of the following criteria:

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

Must not have

Presence of any liver metastases

Patients with neuroendocrine or small cell carcinoma of the prostate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of study drug through end of study (~5 years)

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a new treatment called [Ac-225]-PSMA-62 in men with prostate cancer that has a specific marker called PSMA."

Who is the study for?

This trial is for adults over 18 with advanced prostate cancer that's resistant to hormone therapy and has come back after treatment. They must have good organ function, an ECOG performance status of 0-2, a life expectancy of at least 6 months, and agree to use two forms of contraception. People with HIV can join if they're healthy. Participants should be out of other treatment options.

What is being tested?

[Ac-225]-PSMA-62 is being tested in this phase I/II study on patients whose prostate cancer cells have PSMA. The trial aims to see how safe it is and how well it works across multiple centers where everyone knows what treatment they're getting.

What are the potential side effects?

Potential side effects may include typical reactions related to radiation therapies such as fatigue, nausea, or changes in blood counts leading to increased infection risk or bleeding tendencies. Organ-specific inflammation might also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is worsening despite treatment.

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My prostate cancer has been confirmed by a lab test.

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My bone scan shows new lesions.

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I have tried all approved treatments for my condition without success.

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My PSA level is 0.2ng/mL or higher after prostate surgery.

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My testosterone levels are very low.

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My cancer has returned after initial treatment, and my testosterone levels are normal.

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My PSA levels have risen by 2 ng/mL or more after radiation only treatment.

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I do not need immediate radiation treatment.

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I can take care of myself and perform daily activities.

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My cancer has grown by 20% or more, or I have new cancer spots since starting treatment.

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I haven't had prostate cancer treatment since my last PSMA scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my liver.

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My prostate cancer is of the neuroendocrine or small cell type.

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I have had chemotherapy before.

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I have taken PARP inhibitors for prostate cancer.

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My cancer has spread to my brain.

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I am experiencing symptoms or have been diagnosed with potential spinal cord compression.

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I have a blockage in my urinary system that hasn't been treated.

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I have mild dry mouth or dry eyes.

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I have a history of abnormal heart rhythms or inherited long QT syndrome.

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I have received treatment with specific radioactive medications.

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I have had severe blood cell count issues that took a long time to recover.

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I am not allergic to any components of the [Ac-225]-PSMA-62 therapy.

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I have previously received immunotherapy or T-cell therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of study drug through end of study (~5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of study drug through end of study (~5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug through end of study (~5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD)

Safety and tolerability

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

Secondary study objectives

Absorbed dose estimates (Gy) in normal organs

Objective Response Rate (ORR)

Patient Reported Outcome (PRO) - Impact of treatment toxicity

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: mCRPCExperimental Treatment1 Intervention

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.

Group II: OmHSPCExperimental Treatment1 Intervention

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.

0 / 25Eligibility criteria met