Lutetium-177 for Prostate Cancer

Recruiting at 9 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must not be taking: QT-prolonging agents

Disqualifiers: PSMA therapy, QT issues, urinary obstruction, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 18-36 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will address health authorities' requests to determine whether moderate and severe renal impairment have an impact on the biodistribution, dosimetry and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) administered to participants with progressive PSMA-positive metastatic castration-resistant prostate cancer. The study will also characterize the risk of QT prolongation of AAA617 in this participant population.

Will I have to stop taking my current medications?

The trial requires that you stop using any medications known to prolong the QT interval (a measure of heart rhythm) from the start of screening to the end of the first treatment cycle, unless you can stop them permanently for the study duration.

What data supports the effectiveness of the drug Lutetium-177 Vipivotide Tetraxetan for prostate cancer?

The drug Lutetium-177 Vipivotide Tetraxetan has been shown to improve survival and quality of life in patients with advanced prostate cancer, as demonstrated in the VISION trial. It targets a specific protein found in prostate cancer cells, delivering radiation directly to the cancer, which helps to kill the cancer cells while sparing normal tissues. ^{1 2 3 4 5}

Is Lutetium-177 safe for humans?

Lutetium-177 vipivotide tetraxetan has been approved for treating prostate cancer, indicating it has been evaluated for safety. It targets cancer cells specifically, which helps minimize damage to normal tissues, suggesting a favorable safety profile. ^{1 2 3 4 5}

What makes the drug Lutetium-177 Vipivotide Tetraxetan unique for prostate cancer treatment?

Lutetium-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 most normal tissues. ^{1 2 3 4 5}

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for adults with advanced prostate cancer that's spread and doesn't respond to hormone therapy. They need different levels of kidney function, from normal to severely impaired, but stable. Participants must show cancer progression through bone scans or rising PSA levels, have a decent performance status (able to carry out daily activities), and testosterone under control.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

My PET/CT scan shows positive for 68Ga-PSMA-11 and is approved by the trial's review.

My testosterone levels are very low.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive a dose of 7.4 GBq (±10%) of AAA617 once every 6 weeks for 3 to 6 cycles based on renal function

18-36 weeks

1 visit every 6 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Long Term Follow-up

Participants are monitored for safety up to 10 years after the first dose of AAA617

Up to 10 years

Treatment Details

Interventions

• Lutetium (177Lu) Vipivotide Tetraxetan

Trial Overview The study tests Lutetium (177Lu) Vipivotide Tetraxetan in patients with varying degrees of kidney health. It aims to see how the drug spreads in the body, its safety profile, and if it affects heart rhythm in those with metastatic castration-resistant prostate cancer.

Participant Groups

Group I: AAA617 Experimental Treatment 2 Interventions

Participants will receive a dose of 7.4 GBq (200 mCi) +/- 10% of AAA617 which will be administered once every 6 weeks (1 cycle) for 3 to 6 cycles according to eGFR calculation at screening and radiation absorbed dose results from Cycle1 Day1.

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]

In a phase 3 trial involving 831 patients with metastatic castration-resistant prostate cancer, the addition of [177Lu]Lu-PSMA-617 to standard care significantly delayed the time to first symptomatic skeletal event, with a median of 11.5 months compared to 6.8 months for standard care alone.

Patients receiving [177Lu]Lu-PSMA-617 also reported improved health-related quality of life and less pain, although there were some serious adverse events, including hematological issues, indicating the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-related quality of life and pain outcomes with [177Lu]Lu-PSMA-617 plus standard of care versus standard of care in patients with metastatic castration-resistant prostate cancer (VISION): a multicentre, open-label, randomised, phase 3 trial. Fizazi, K., Herrmann, K., Krause, BJ., et al.[2023]

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]

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

Health-related quality of life and pain outcomes with [177Lu]Lu-PSMA-617 plus standard of care versus standard of care in patients with metastatic castration-resistant prostate cancer (VISION): a multicentre, open-label, randomised, phase 3 trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

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