What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly those involving targeted radiotherapy using radiopharmaceutical agents such as Ra-223 and lutetium Lu 177 vipivotide tetraxetan, often have side effects including myelosuppression, nephrotoxicity, and salivary gland toxicity (pain, swelling, and dry mouth). Other frequently reported adverse events include fatigue, nausea, anorexia, constipation, fever, and vomiting. These treatments can also lead to a higher risk of fractures, which can be mitigated by the use of osteoclast inhibitors.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including radiopharmaceutical agents. Notably, lutetium Lu 177 vipivotide tetraxetan was approved for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) following the VISION trial, which demonstrated improved progression-free and overall survival. Additionally, radium-223 (Ra-223) has been used in combination with other therapies like abiraterone and enzalutamide, showing potential benefits in disease progression and survival. These approvals highlight the evolving landscape of targeted radiotherapy in prostate cancer treatment.

What other types of research exist?

Promising novel alternatives to FPI-2265 for prostate cancer patients include: <ol> <li>225Ac-PSMA-617: This targeted alpha therapy has shown good response rates in mCRPC patients who have failed taxane-based chemotherapy, with significant PSA and radiological responses.</li> <li>177Lu-PSMA-617: This radionuclide treatment has demonstrated high response rates, low toxicity, and pain reduction in men with mCRPC who have progressed after conventional treatments.</li> <li>Niraparib: A PARP inhibitor evaluated in the GALAHAD trial, showing activity in prostate cancer patients with BRCA1/2 mutations and other HRR gene abnormalities.</li> <li>Olaparib: Another PARP inhibitor, which in the PROPEL trial, showed significant prolongation in radiographic progression-free survival in mCRPC patients, regardless of HRR status.</li> </ol>

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Radioisotope Therapy

Ac225-PSMA I&T for Prostate Cancer (TATCIST Trial)

Phase 2

Recruiting

Led By Rodolfo Nunez, MD

Research Sponsored by Fusion Pharmaceuticals Inc.

Eligibility Criteria Checklist

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

Must have

Received ≥ 1 androgen receptor axis-targeted therapies (ARAT)

Adenocarcinoma of prostate proven by histopathology

Must not have

Abnormal renal function, baseline Hgb, ANC, platelets, and prothrombin time, international normalized ratio or prothrombin time test outside specified limits

Symptomatic cord compression or impending cord compression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment until 12 weeks after the first treatment.

Awards & highlights

No Placebo-Only Group

Summary

This trial involves giving patients FPI-2265 in specific amounts. The amounts may be adjusted based on how the patients respond to the treatment.

Who is the study for?

This trial is for men with advanced prostate cancer that can't be removed, has spread, and isn't responding to certain therapies like docetaxel. Participants must understand the study, sign consent, have a life expectancy of at least 6 months, and meet specific health criteria including blood counts and organ function tests.

What is being tested?

The TATCIST trial is testing a treatment called Ac225-PSMA I&T in men with castration-resistant prostate cancer. It involves four doses of this targeted alpha therapy which seeks out cancer cells using a molecule that binds to PSMA receptors on tumor cells.

What are the potential side effects?

Potential side effects may include risks associated with radiation such as bone marrow suppression (low blood cell counts), kidney damage or dryness in mouth/eyes from previous treatments. Specific side effects of Ac225-PSMA I&T are not listed but would likely relate to its mechanism of action.

Eligibility Criteria

Inclusion Criteria

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

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I have received at least one therapy targeting the androgen receptor.

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My prostate cancer was confirmed through tissue examination.

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My cancer has spread and cannot be removed with surgery.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My liver is working within normal ranges.

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My prostate cancer is worsening despite treatment.

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I have a BRCA mutation and have been treated with FDA-approved therapies.

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My prostate cancer is not responding to hormone therapy, with testosterone levels ≤ 50 ng/dL.

Exclusion Criteria

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

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My kidney function and blood tests are not within normal ranges.

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I am experiencing symptoms due to spinal cord pressure.

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I have long-term dry eyes or mouth from previous therapy.

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I have a blockage in my urinary tract confirmed by a scan.

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I have cancer, but it's not one of the few exceptions listed.

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I have had more than 4 treatments for prostate cancer after it spread.

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I have not had major surgery in the last 30 days.

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My bone scan shows widespread cancer spread in my bones.

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I have lasting side effects from cancer treatment that are mild.

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My cancer has spread to my brain or liver.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment until 12 weeks after the first treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment until 12 weeks after the first treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment until 12 weeks after the first treatment. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To evaluate the effect of FPI-2265 on prostate-specific antigen (PSA) in participants with mCRPC.

Secondary study objectives

To assess the impact of FPI-2265 on participant reported outcomes.

To evaluate the anti-tumor activity of FPI-2265.

To evaluate the safety and tolerability of FPI- 2265.

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: FPI-2265Experimental Treatment1 Intervention

All patients will receive FPI-2265, administered at 8 ± 1-week interval, with the initial activity of 100 kBq/kg (±10%).

0 / 18Eligibility 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

Prostate cancer treatments work through various mechanisms to target and destroy cancer cells. Targeted alpha therapy, such as with 225Ac-PSMA-617, uses alpha particles to deliver high-energy radiation directly to cancer cells, minimizing damage to surrounding healthy tissue. Immunotherapy, like sipuleucel-T, stimulates the patient's immune system to recognize and attack cancer cells. Androgen receptor targeted therapies, such as enzalutamide, block the action of androgens (male hormones) that fuel the growth of prostate cancer cells. Radionuclide treatments, like 177Lu-PSMA-617, involve radiopharmaceutical agents that bind to prostate-specific membrane antigen (PSMA) on cancer cells, delivering targeted radiation to kill them. These treatments are crucial for prostate cancer patients as they offer targeted approaches that can reduce side effects and improve efficacy compared to conventional therapies.

225 Ac-PSMA-617-targeted alpha therapy for the treatment of metastatic castration-resistant prostate cancer: A systematic review and meta-analysis.[177Lu]-PSMA-617 radionuclide treatment in patients with metastatic castration-resistant prostate cancer (LuPSMA trial): a single-centre, single-arm, phase 2 study.New therapies for castration-resistant prostate cancer: efficacy and safety.