Lutetium Vipivotide Tetraxetan for Prostate Cancer

(RADIODOSE Trial)

Recruiting at 7 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Novartis Pharmaceuticals

Must be taking: ARPI

Must not be taking: Cytotoxic chemotherapy, Immunotherapy

Disqualifiers: Cardiac disease, Active malignancies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

Duration: 74 weeks

106 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to assess and evaluate dosimetry, safety, and tolerability following administration of up to 12 cycles of (177Lu) vipivotide tetraxetan (also referred to as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617) in taxane-naïve adult participants with PSMA-positive mCRPC who progressed on a prior ARPI treatment with normal renal function or mild renal impairment (eGFR ≥ 60ml/min).

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot take certain treatments like chemotherapy, immunotherapy, or radioligand therapy while participating in the study.

What data supports the effectiveness of the drug Lutetium Lu 177 vipivotide tetraxetan for prostate cancer?

The drug Lutetium Lu 177 vipivotide tetraxetan was shown to improve overall survival in patients with prostate cancer in a clinical trial. Patients receiving the drug lived a median of 15.3 months compared to 11.3 months for those who did not receive it, indicating a significant benefit. ^{1 2 3 4 5}

Is Lutetium Lu 177 vipivotide tetraxetan safe for humans?

Lutetium Lu 177 vipivotide tetraxetan, also known as Pluvicto, has been approved by the FDA for treating a specific type of prostate cancer, indicating it has been evaluated for safety. It was tested in a large clinical trial (VISION trial) where it showed a significant improvement in survival, suggesting it is generally safe for use in humans with this condition. ^{1 2 3 4 5}

What makes the drug Lutetium Lu 177 vipivotide tetraxetan unique for prostate cancer treatment?

Lutetium Lu 177 vipivotide tetraxetan is unique because it is the first FDA-approved targeted radioligand therapy for prostate cancer, specifically targeting prostate-specific membrane antigen (PSMA) on cancer cells to deliver radiation directly, causing DNA damage and cell death. This precision approach allows for highly individualized treatment, focusing on cancer cells while sparing normal tissues. ^{1 2 3 4 5}

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

Adults over 18 with metastatic castration-resistant prostate cancer (mCRPC) that's PSMA-positive. They should have normal or mildly impaired kidney function, an ECOG performance status ≤1, and testosterone levels under control by treatment or surgery. Only those who've progressed after one type of advanced hormone therapy can join.

Inclusion Criteria

I have signed the consent form to participate in this study.

I can carry out all my self-care but cannot do heavy physical work.

My prostate cancer is confirmed to be adenocarcinoma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive up to 12 cycles of AAA617 treatment every 6 weeks

74 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

2 visits (in-person)

Long-term Follow-up

Participants are followed for safety every 12 weeks for selected adverse events

Up to 12 months

Treatment Details

Interventions

• Lutetium (177Lu) Vipivotide Tetraxetan

Trial Overview The trial is testing the safety and how well patients tolerate AAA617, a radioactive drug given for up to 12 cycles. It also looks at radiation dosimetry—how the drug distributes within the body—in men who haven't had chemotherapy but whose cancer has worsened despite hormone-blocking treatments.

Participant Groups

Group I: AAA617 Experimental Treatment 3 Interventions

All participants will receive the investigational product AAA617 (7.4 GBq ±10%).

Lutetium (177Lu) Vipivotide Tetraxetan is already approved in United States, European Union for the following indications:

Approved in United States as Pluvicto for:

• Prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer

Approved in European Union as Pluvicto for:

• Prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Findings from Research

Lutetium Lu 177 vipivotide tetraxetan (PLUVICTO™) is a targeted radioligand therapy approved in the USA for treating metastatic castration-resistant prostate cancer (mCRPC) that expresses prostate-specific membrane antigen (PSMA), based on positive results from the phase 3 VISION trial.

This therapy specifically targets PSMA, which is overexpressed in prostate cancer cells, allowing for a more effective treatment option for patients who have already undergone other therapies like androgen receptor inhibition and taxane-based chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lutetium Lu 177 Vipivotide Tetraxetan: First Approval. Keam, SJ.[2022]

177Lu-vipivotide tetraxetan is a targeted radiopharmaceutical that effectively treats metastatic castration-resistant prostate cancer (mCRPC) by delivering beta-radiation directly to cancer cells, demonstrating safety and tolerability in clinical trials.

Approved by the FDA in March 2022 based on the VISION trial, this therapy is particularly beneficial for patients who have already undergone androgen receptor pathway inhibition and taxane-based chemotherapy, highlighting its role as a new treatment option in advanced prostate cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lutetium Lu 177 vipivotide tetraxetan for metastatic castration-resistant prostate cancer. Shah, H., Ravi, P., Sonpavde, G., et al.[2023]

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is an approved treatment for adult patients with advanced prostate cancer that expresses the prostate-specific membrane antigen (PSMA).

This therapy is specifically indicated for patients who have already undergone treatment with androgen receptor pathway inhibitors and taxane-based chemotherapy, highlighting its role in later-stage cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Drug for Metastatic Castration-Resistant Prostate Cancer. Aschenbrenner, DS.[2022]

The FDA approved Pluvicto (177Lu-PSMA-617) for treating metastatic castration-resistant prostate cancer (mCRPC) in patients who have undergone prior treatments, showing a significant improvement in overall survival (15.3 months vs. 11.3 months with standard care) in a trial with 831 participants.

Common side effects of Pluvicto include fatigue, dry mouth, and nausea, with notable laboratory abnormalities such as decreased lymphocytes and hemoglobin occurring in over 30% of patients, indicating the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer. Fallah, J., Agrawal, S., Gittleman, H., et al.[2023]

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is the first FDA-approved targeted radioligand therapy for metastatic castration-resistant prostate cancer (mCRPC), specifically for patients with high levels of prostate-specific membrane antigen (PSMA).

This treatment works by binding to PSMA, which is overexpressed in prostate cancer cells, allowing targeted radiation to damage DNA and induce cell death, making it a promising option in precision medicine for individualized cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lutetium Lu 177 vipivotide tetraxetan for prostate cancer. Liu, X., Fang, GC., Lu, H., et al.[2023]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Lutetium Lu 177 Vipivotide Tetraxetan: First Approval. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Lutetium Lu 177 vipivotide tetraxetan for metastatic castration-resistant prostate cancer. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

New Drug for Metastatic Castration-Resistant Prostate Cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer. [2023]

5. Spain pubmed.ncbi.nlm.nih.gov

Lutetium Lu 177 vipivotide tetraxetan for prostate cancer. [2023]