Lutetium (177Lu) Vipivotide Tetraxetan for Prostate Cancer

(PSMA-DC Trial)

Recruiting at 166 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Must not be taking: Anti-androgens, CYP17 inhibitors

Disqualifiers: De novo OMPC, Unmanageable bladder issues, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

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

Compensation: Varies

Number of Visits: 2

Duration: 24 weeks

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called lutetium vipivotide tetraxetan, a type of radioligand therapy, for individuals with oligometastatic prostate cancer. This cancer has spread to a few small areas after initial treatment. The trial aims to determine if this treatment can control the cancer's spread and delay the need for hormone therapy, which often has challenging side effects. Participants will either receive this treatment or undergo close monitoring after standard radiation therapy. Men with confirmed prostate cancer that has spread to a few small areas and recurred after surgery or radiation may be suitable for this trial. As a Phase 3 trial, this treatment is in the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking cancer therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, certain hormonal therapies, radiopharmaceutical agents, immunotherapy, and chemotherapy are not allowed if taken recently. It's best to discuss your specific medications with the trial team.

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

Research has shown that lutetium (177Lu) vipivotide tetraxetan is approved in the U.S. for treating certain prostate cancers, indicating thorough safety testing in people. In studies, patients who received this treatment showed better results than those who did not.

Most people tolerate the treatment well, but some may experience side effects such as tiredness, nausea, or lower blood cell counts. These side effects are usually temporary and manageable. Discuss any risks with a doctor before starting a new treatment. ^{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 introduces a targeted approach to treating prostate cancer. Unlike traditional treatments like hormone therapy or chemotherapy, which can affect the whole body, this treatment uses a radioactive compound that specifically targets and binds to prostate cancer cells. This targeted delivery allows the radiation to attack cancer cells more directly while sparing much of the surrounding healthy tissue. Researchers are excited about this treatment because it promises increased effectiveness with potentially fewer side effects, offering new hope for patients with metastatic prostate cancer.

What evidence suggests that lutetium (177Lu) vipivotide tetraxetan could be an effective treatment for prostate cancer?

Research has shown that lutetium (177Lu) vipivotide tetraxetan, which participants in this trial may receive, is a promising treatment for prostate cancer. One study found that this treatment, when combined with standard care, reduced the risk of cancer progression or death by 28%. The USA has approved it for treating a specific type of advanced prostate cancer, underscoring its effectiveness. This treatment targets PSMA, a molecule on prostate cancer cells, delivering radiation directly to the tumor. Early results indicate that it can extend the lives of patients with advanced prostate cancer. The treatment aims to control the disease while maintaining the patient's quality of life. ^{1 4 6 7 8}

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 over 18 with oligometastatic prostate cancer (OMPC) who've had prior treatment to their primary tumor. They should have a life expectancy of at least 24 months, an ECOG performance status of 0 or 1, and no more than five PSMA-positive metastatic lesions. Participants must not be eligible if they show clear signs of metastasis on conventional imaging that aren't related to the tumor.

Inclusion Criteria

I have at least one cancer spread that is PSMA-positive.

I have prostate cancer with 5 or fewer PSMA-positive spots found on a special scan.

Participants must have a negative conventional imaging for M1 disease at screening

Exclusion Criteria

I have another cancer diagnosis that could affect my life expectancy or interfere with this cancer's assessment.

I have severe bladder control problems that can't be managed.

I was diagnosed with prostate cancer when it was first found.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Stereotactic Body Radiation Therapy (SBRT)

SBRT is administered to all metastatic prostate cancer lesions after randomization

3 weeks

Multiple visits for radiation sessions

Treatment

Participants in the investigational arm receive up to 4 cycles of AAA617, while the control arm undergoes observation

24 weeks

Weekly visits during cycles 1 and 3, and every 16 weeks thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment

42 days

Safety follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Lutetium (177Lu) Vipivotide Tetraxetan

Trial Overview The study tests Lutetium (177Lu) vipivotide tetraxetan (AAA617), aiming to control recurrent tumors in early-stage prostate cancer patients and delay the need for androgen deprivation therapy. It compares this new treatment's effectiveness and safety against simply observing the progression without intervention.

How Is the Trial Designed?

Group I: Investigational Arm: lutetium (177Lu) vipivotide tetraxetan (AAA617) Experimental Treatment 1 Intervention

All participants will be treated with Stereotactic Body Radiation Therapy (SBRT) to all metastatic lesions followed by a dose of 7.4 GBq (200 mCi) +/- 10% of AAA617 which will be administered once every 6 weeks (1 cycle) for a planned 4 cycles.

Group II: Control arm: observation (watchful waiting) Active Control 1 Intervention

All participants will be treated with Stereotactic Body Radiation Therapy (SBRT) to all metastatic lesions followed by observation only.

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

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9099330/

Lutetium Lu 177 Vipivotide Tetraxetan: First Approval - PMC Lutetium Lu 177 vipivotide tetraxetan was approved in the USA on 23 March 2022 for the treatment of adult patients with PSMA-positive metastatic castration- ...

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

Patient characteristics and overall survival with lutetium (Lu ... Real-world comparison of lutetium-177 vipivotide tetraxetan in advanced castration resistant metastatic prostate cancer patients in Appalachia.

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

Lutetium Lu 177 Vipivotide Tetraxetan Efficacy and Toxicity ... This study focused on 45 patients treated with LuVT from September 2022 to September 2023. Data collection for each patient included prostate ...

4. 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 ... Metastatic prostate cancer has a poor prognosis, with a 5-year survival rate of 36.6%, which drops further to 15% in patients with metastatic ...

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. 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 ...

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. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.TPS431

A phase I/II study of neoadjuvant, intra-arterial ... Real-world comparison of lutetium-177 vipivotide tetraxetan in advanced castration resistant metastatic prostate cancer patients in Appalachia.