Lutetium (177Lu) Vipivotide Tetraxetan for Prostate Cancer

(PSMA-DC Trial)

Recruiting at 111 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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. 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 progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).

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.

What data supports the effectiveness of the drug Lutetium (177Lu) Vipivotide Tetraxetan for prostate cancer?

The drug Lutetium (177Lu) Vipivotide Tetraxetan has been shown to improve overall survival in patients with prostate cancer, as demonstrated in the VISION trial. Patients receiving the drug lived a median of 15.3 months compared to 11.3 months for those receiving standard care alone. ^{1 2 3 4 5}

Is Lutetium (177Lu) Vipivotide Tetraxetan safe for humans?

Lutetium (177Lu) 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, which showed it can be used safely in humans, although like all treatments, it may have side effects. ^{1 2 3 4 5}

What makes the drug Lutetium (177Lu) Vipivotide Tetraxetan unique for prostate cancer?

Lutetium (177Lu) 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, minimizing damage to normal tissues. ^{1 2 3 4 5}

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

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]