Long-Term Safety of AAA617 for Prostate Cancer

Recruiting at 74 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: Novartis Pharmaceuticals

Disqualifiers: Inability to complete examinations

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the long-term safety of a treatment called AAA617 for prostate cancer. It examines the risks and any serious side effects that might occur over time in individuals who have already received the treatment in earlier studies. Participants will not receive any new treatments but will be monitored for up to 10 years. This trial suits those who have had at least one dose of AAA617 in previous Novartis-sponsored prostate cancer trials and have met all requirements to join this follow-up study. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved and effective treatment benefits more patients over time.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What is the safety track record for AAA617?

Research has shown that AAA617, also known as lutetium (177Lu) vipivotide tetraxetan, has been tested for safety in treating prostate cancer. Studies have found that patients generally tolerate this treatment well, though some side effects have been reported. Common side effects include fatigue, dry mouth, and nausea. More serious side effects can occur but are less common.

In earlier studies, patients tolerated up to six cycles of AAA617. The FDA has already approved it for treating certain types of prostate cancer, indicating it is reasonably safe to use. However, this trial specifically examines the long-term effects to identify any risks that might appear over time. While strong evidence supports short-term safety, the trial aims to ensure long-term safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

AAA617 is unique because it focuses on long-term safety for prostate cancer treatment, unlike many existing therapies that primarily address immediate outcomes. Current standard treatments often include hormone therapies, chemotherapy, or radiation, which can have significant side effects over time. Researchers are excited about AAA617 because it aims to ensure that patients can manage prostate cancer with minimal long-term adverse effects, potentially improving quality of life over the years. This focus on safety without administering ongoing treatment is a novel approach in the field.

What is the effectiveness track record for AAA617 in treating prostate cancer?

Research has shown that the treatment AAA617, also known as 177Lu-PSMA-617, holds promise for prostate cancer patients. In earlier studies, patients who began this therapy lived an average of about 15.3 months. This suggests that AAA617 can extend patient survival compared to other treatments. Additionally, when combined with standard care, AAA617 can slow prostate cancer progression, reducing the risk of worsening or death by 28%. These findings support the effectiveness of AAA617 in managing prostate cancer. ^{5 6 7 8 9}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adult men with prostate cancer who have previously received at least one dose of AAA617 in a Novartis-sponsored clinical trial. Participants must consent to the study and agree to use condoms during intercourse for up to 14 weeks after their last treatment.

Inclusion Criteria

I have received AAA617 in a Novartis trial for prostate cancer and met all its requirements.

Willingness of sexually active participant to use a condom during intercourse for up to 14 weeks from the last dose of AAA617 treatment administered on the parent study

Signed informed consent must be obtained prior to participation in the study

Exclusion Criteria

Inability to complete the needed investigational examinations due to any reason

Timeline for a Trial Participant

Baseline

Participants enroll into the long-term follow-up study after completing the parent treatment study requirements

Variable

Follow-up

Participants are monitored for selected adverse events and laboratory parameters

Up to 10 years

Visits every 6-8 months

Long-term follow-up

Participants are followed until death, lost to follow-up, or up to 10 years from first dose of AAA617

Up to 10 years

What Are the Treatments Tested in This Trial?

Interventions

• AAA617

Trial Overview The study aims to understand the long-term safety of Lutetium (177Lu) Vipivotide Tetraxetan, also known as AAA617, in treating prostate cancer. It will track any serious side effects that occur over time in patients who've used this drug.

How Is the Trial Designed?

Group I: Single arm Experimental Treatment 1 Intervention

Participants will be followed until death, lost to follow-up, or up to 10 years from first dose of AAA617, whichever occurs first. There will be no study treatment administered to participants while participating in this study.

AAA617 is already approved in United States, European Union for the following indications:

Approved in United States as Pluvicto for:

• Prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC)

Approved in European Union as Pluvicto for:

• Prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC)

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

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]

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]

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]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.63

Patient characteristics and overall survival with lutetium (Lu ... The median OS from start of 177Lu-PSMA-617 therapy was 15.3 months (95% confidence interval [CI]: 14.6–16.3); a total of 137/643 (21.3%) ...

2. 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%) ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05939414

NCT05939414 | An Open-label Study Comparing Lutetium ... The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/early/2025/09/25/jnumed.125.270704

First-Line [177Lu]Lu-PSMA-617 Therapy Without ADT ... In the phase 3 PSMAfore trial, [177Lu]Lu-PSMA-617 demonstrated significantly improved radiographic progression-free survival compared with an ...

5. 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, ...

6. novartis.com novartis.com/clinicaltrials/study/nct05803941

Long-Term Safety of Lutetium (177Lu) Vipivotide ... The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06894511

NCT06894511 | An Open-label Study Comparing Lutetium ... The purpose of this study is to assess whether the combination of AAA617 (administered for 6 cycles at a dose of 7.4 GBq (200 mCi) +/- 10%) and ARPI ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12481865/

Adverse events associated with Lutetium-177-PSMA-617 ... Pluvicto® can bind to prostate cancer cells expressing prostate-specific membrane antigen and induce DNA damage through the radiation released ...

9. ema.europa.eu ema.europa.eu/en/documents/rmp/pluvicto-epar-risk-management-plan_en.pdf

Pluvicto, INN-lutetium (177Lu) vipivotide tetraxetan - EMA Long-term toxicity. The proposed indication is for late stage prostate cancer patients with a short life-expectancy. Long-term toxicity of lutetium (177Lu) ...