Lutetium-177 for Prostate Cancer

Recruiting at 13 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an experimental treatment called Lutetium-177 Vipivotide Tetraxetan for prostate cancer that has spread and resists traditional hormone treatments. Researchers aim to understand how this treatment behaves in the body, particularly in individuals with kidney issues, and whether it affects heart rhythm. Suitable candidates include those with worsening prostate cancer despite treatment and stable kidney disease. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that lutetium (177Lu) vipivotide tetraxetan is likely to be safe for humans?

Research shows that lutetium (177Lu) vipivotide tetraxetan may help treat prostate cancer. Patients in earlier studies experienced improvements in their prostate-specific antigen (PSA) levels, which doctors use to monitor prostate cancer. In one study, 68.9% of participants had their PSA levels drop by at least 10%, and 55.6% saw a reduction of 50% or more. While these results are promising, awareness of possible side effects is important.

Earlier studies suggest that the treatment is generally well-tolerated. However, like any treatment, it can have side effects. The most common ones include fatigue, nausea, and dry mouth. Serious side effects are less common but can occur. Notably, the FDA has approved this treatment for another condition, indicating some confidence in its safety.

In summary, lutetium (177Lu) vipivotide tetraxetan has shown potential benefits in treating prostate cancer, and while side effects are possible, the treatment is usually well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Lutetium (177Lu) Vipivotide Tetraxetan is unique because it combines a radioactive isotope, Lutetium-177, with a targeting molecule that seeks out prostate-specific membrane antigen (PSMA) on cancer cells. Unlike standard treatments like hormone therapy or chemotherapy, which can affect both healthy and cancerous cells, this treatment delivers targeted radiation directly to the prostate cancer cells, potentially minimizing damage to healthy tissue. Researchers are excited because this targeted approach could lead to fewer side effects and improved outcomes for patients with advanced prostate cancer.

What evidence suggests that Lutetium-177 might be an effective treatment for prostate cancer?

Research shows that lutetium-177 vipivotide tetraxetan, also known as Pluvicto™, can help treat prostate cancer. In this trial, participants will receive the treatment under the label AAA617. Studies have found that this treatment, when combined with standard care, reduces the risk of cancer progression or death by 28%. Additionally, 68.9% of patients experienced at least a 10% decrease in a key cancer marker (PSA), and more than half saw a reduction of 50% or more. On average, patients starting this therapy live about 15.3 months. These findings suggest that lutetium-177 vipivotide tetraxetan could be a promising option for prostate cancer patients. ^{2 3 4 6 7}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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 up to 6 cycles if enrolled in Cohorts A or B. Participants with severe renal impairment (in cohort C) will receive a dose of 7.4 GBq of AAA617 for up to 3 cycles of treatment. Based on the emerging safety data and if the investigators deem the participant is still benefiting from study drug, 3 additional cycles may be administered for Cohort C participants.

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

Published Research Related to This Trial

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]

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]

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 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]

Citations

1. urotoday.com urotoday.com/conference-highlights/asco-gu-2025/asco-gu-2025-prostate-cancer/158159-asco-gu-2025-patient-characteristics-and-overall-survival-with-lutetium-lu177-vipivotide-tetraxetan-177lu-psma-617-a-real-world-analysis-of-early-adopters.html

Patient characteristics and overall survival with lutetium ... The median overall survival from the start of ¹⁷⁷Lu-PSMA-617 therapy was 15.3 months (95% CI: 14.6–16.3), with 137 of 643 patients (21.3%) ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.84

Clinical outcomes of lutetium-177-vipivotide tetraxetan in ... In this retrospective study of 177 Lu, we see similar PSA and PSA50 responses to reported trials. However, PFS was shorter, and mortality was higher.

3. novartis.com novartis.com/news/media-releases/psmaddition-data-show-novartis-pluvictotm-delays-progression-end-stage-prostate-cancer

PSMAddition data show Novartis Pluvicto™ delays ... PluvictoTM plus standard of care (ARPI + ADT) significantly reduced risk of progression or death by 28% (HR 0.72) versus SoC alone, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2452109425002040

Lutetium Lu 177 Vipivotide Tetraxetan Efficacy and Toxicity ... 68.9% of the cohort observed PSA biomarker improvement of ≥10%, and 55.6% with ≥50% PSA reduction. Three patients (6.7%) achieved a complete ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05939414

NCT05939414 | An Open-label Study Comparing Lutetium ... The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10159870/

Lutetium Lu 177 Vipivotide Tetraxetan for Patients with ... The FDA granted approval based on a statistically significant and clinically meaningful improvement in overall survival when 177Lu-PSMA-617 was combined with ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.86

Real world outcomes in patients with metastatic castration ... 47 patients (71%) had an overall decline in their PSA from baseline, with 32 patients (49%) experiencing a decrease greater than fifty percent.