What is the mechanism of action of this treatment?

Targeted radiotherapy using Lutetium-177, such as 177Lu-rhPSMA-10.1, involves attaching the radioactive isotope Lutetium-177 to a molecule that specifically binds to Prostate-Specific Membrane Antigen (PSMA) on prostate cancer cells. This allows for direct delivery of radiation to the cancer cells, minimizing damage to surrounding healthy tissue. Androgen deprivation therapy (ADT) reduces levels of male hormones that can promote prostate cancer growth, while chemotherapy uses drugs to kill rapidly dividing cancer cells. These treatments are crucial for managing prostate cancer, especially in advanced stages, as they can slow disease progression, reduce symptoms, and improve survival rates.

What side effects are associated with this type of intervention?

Targeted radiotherapy using Lutetium-177, such as 177Lu-rhPSMA-10.1, commonly causes side effects including fatigue, dry mouth, nausea, and bone marrow suppression, which can lead to anemia, thrombocytopenia, and leukopenia. Other treatments for prostate cancer, like chemotherapy, can cause hair loss, gastrointestinal issues, and increased risk of infections. Immunotherapy may lead to immune-related adverse events such as colitis, dermatitis, and endocrinopathies. Radiopharmaceuticals like Ra-223 can cause bone pain, diarrhea, and hematologic toxicity. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that involve targeted radiotherapy using Lutetium-177. One notable example is Lutetium Lu 177 vipivotide tetraxetan, which targets PSMA-expressing metastatic castration-resistant prostate cancer (mCRPC). This treatment delivers radiation directly to cancer cells, similar to the mechanism being studied in the trial for 177Lu-rhPSMA-10.1. Additionally, other radioligand therapies and beta-emitting radioisotopes like Ra-223 (radium-223) have been used in the management of prostate cancer, particularly for bone metastases.

What other types of research exist?

Promising alternatives to 177Lu-rhPSMA-10.1 for prostate cancer treatment include: 1) Radium-223, an alpha-emitting radiopharmaceutical approved for castration-resistant prostate cancer with bone metastases, which has shown improved overall survival and reduced skeletal-related events. 2) Combination therapies such as Ra-223 with abiraterone or enzalutamide, which have shown potential for improved survival and manageable safety profiles. 3) Beta-emitting radioisotopes like Strontium-89 and Samarium-153, which are used for pain palliation in bone metastases and have been evaluated for their efficacy and safety. These alternatives offer different mechanisms of action and may be considered based on individual patient profiles and treatment goals.

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Radioisotope Therapy

177Lu-rhPSMA-10.1 for Prostate Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Blue Earth Therapeutics Ltd

Eligibility Criteria Checklist

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

Must have

Positive disease expression of PSMA as confirmed on PSMA PET/CT scan

At least 4 weeks or 5 half-lives (whichever is longer) elapsed between last anti-cancer treatment administration and the initiation of study treatment (except for Luteinising Hormone-releasing Hormone or GnRH)

Must not have

Presence of significant PSMA-negative disease on ceCT/MRI scan

Ongoing treatment with bisphosphonates for bone-targeted therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weekly intervals

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new radioactive treatment for men with advanced prostate cancer that doesn't respond to hormone therapy. The treatment targets and kills cancer cells by delivering radiation directly to them. This new approach has shown promise in extending survival for men with advanced prostate cancer.

Who is the study for?

Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread, who are in fairly good health (able to perform daily activities) with a life expectancy of at least 6 months. They must have had no recent major surgeries or other cancer treatments, and their cancer should be visible on scans and produce a specific protein seen on PET/CT scans.

What is being tested?

The trial is testing the safety and effectiveness of an injection called 177Lu-rhPSMA-10.1 for men whose prostate cancer can be seen on certain scans and continues to grow despite hormone therapy. The study will also determine the right dose and measure how the body processes the drug.

What are the potential side effects?

Possible side effects may include allergic reactions to ingredients in the treatment, kidney problems if there's pre-existing damage or obstruction, blood count changes due to bone marrow involvement by disease or treatment, heart issues detectable on ECGs, or worsening urinary issues.

Eligibility Criteria

Inclusion Criteria

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

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My cancer shows positive for PSMA on scans.

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It's been over 4 weeks or 5 half-lives since my last cancer treatment, except for hormone therapy.

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My testosterone levels are low due to treatment.

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I can care for myself and doctors expect me to live 6 months or more.

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I am a man over 18 with confirmed prostate cancer.

Exclusion Criteria

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

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My scans show cancer that does not show up on PSMA tests.

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I am currently receiving bisphosphonates for bone treatment.

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I have severe issues controlling my bladder that could make handling radioactive urine unsafe.

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I have had specific radiation treatments for my cancer.

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I don't have any health issues that would make it unsafe for me to join the study.

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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 tract that hasn't been fixed.

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I have another type of cancer that might affect my life expectancy or interfere with this study.

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I have metallic implants that could interfere with medical imaging.

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My prostate cancer shows neuroendocrine features.

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I have a history of blood cancer.

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My bone scan shows widespread cancer spread in the marrow.

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I have a history of cancer spreading to my brain or spinal cord.

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I've had radiation therapy that affected over 30% of my bone marrow or kidneys.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks post final imp

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks post final imp

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks post final imp for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Phase 1 Frequency and nature of TEAEs

Phase 1 Incidence of DLTs

Phase 2, anti-tumour response

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase 2, Cohort 2, Taxane-naïve mCRPCExperimental Treatment2 Interventions

Subjects with PSMA positive disease will receive up to 6 cycles of the Therapeutic IMP at the Recommended Phase 2 dose \[RP2D\] .

Group II: Phase 2, Cohort 1, post-chemotherapy mCRPCExperimental Treatment2 Interventions

Subjects with PSMA positive disease will receive up to 6 cycles of the Therapeutic IMP at the Recommended Phase 2 dose \[RP2D\]

Group III: Phase 1, Cohort BExperimental Treatment2 Interventions

Subjects with PSMA positive disease will receive 7.4GBq of 177Lu-rhPSMA-10.1 (maximum of 3 cycles).

Group IV: Phase 1, Cohort AExperimental Treatment2 Interventions

Subjects with PSMA positive disease will receive 5.55GBq of 177Lu-rhPSMA-10.1 (maximum of 3 cycles).

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Targeted radiotherapy using Lutetium-177, such as 177Lu-rhPSMA-10.1, involves attaching the radioactive isotope Lutetium-177 to a molecule that specifically binds to Prostate-Specific Membrane Antigen (PSMA) on prostate cancer cells. This allows for direct delivery of radiation to the cancer cells, minimizing damage to surrounding healthy tissue. Androgen deprivation therapy (ADT) reduces levels of male hormones that can promote prostate cancer growth, while chemotherapy uses drugs to kill rapidly dividing cancer cells. These treatments are crucial for managing prostate cancer, especially in advanced stages, as they can slow disease progression, reduce symptoms, and improve survival rates.