Lutetium (177Lu) Vipivotide Tetraxetan for Prostate Cancer

(PSMA-DC Trial)

Recruiting in Palo Alto (17 mi)

+106 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Novartis Pharmaceuticals

Must not be taking: Anti-androgens, CYP17 inhibitors

Disqualifiers: De novo OMPC, Unmanageable bladder issues, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

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.

Trial 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 (Radiopharmaceutical)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

John Hopkins Uni Kimmel Comp Cancer Cntr Research Baltimore, MD

Wash U School of Medicine . Saint Louis, MO

BAMF Health Grand Rapids, MI

Carolina Urologic Research Center, LLC Myrtle Beach, SC

More Trial Locations

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2963

Patients Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Lutetium Lu 177 Vipivotide Tetraxetan: First Approval. [2022] Lutetium Lu 177 vipivotide tetraxetan (PLUVICTO™, formerly known as 177Lu-PSMA-617) is a radioligand therapeutic agent that is being developed by Advanced Accelerator Applications (a subsidiary of Novartis) for the treatment of prostate-specific membrane antigen (PSMA)-expressing metastatic prostate cancer. The active part of the radiopharmaceutical is lutetium-177, which is linked to a ligand that binds to prostate-specific membrane antigen (PSMA), a transmembrane enzyme overexpressed in primary and metastatic prostate cancers. Based on efficacy results from the phase 3 VISION trial, 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-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. Regulatory review in the EU and other countries is underway. This article summarizes the milestones in the development of Lutetium Lu 177 vipivotide tetraxetan leading to this first approval as a therapeutic radioligand for mCRPC.

2. England pubmed.ncbi.nlm.nih.gov

Lutetium Lu 177 vipivotide tetraxetan for metastatic castration-resistant prostate cancer. [2023] Label="INTRODUCTION"> 177Lu-vipivotide tetraxetan is a radiopharmaceutical that selectively targets prostate-specific membrane antigen (PSMA) and delivers beta-radiations to kill prostate cancer cells.

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

New Drug for Metastatic Castration-Resistant Prostate Cancer. [2022] Pluvicto (lutetium Lu 177 vipivotide tetraxetan) has been approved for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have received androgen receptor pathway inhibition and taxane-based chemotherapy.

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] On March 23, 2022, the FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, also known as 177Lu-PSMA-617) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. The recommended 177Lu-PSMA-617 dose is 7.4 gigabecquerels (GBq; 200 mCi) intravenously every 6 weeks for up to six doses, or until disease progression or unacceptable toxicity. The FDA granted traditional approval based on VISION (NCT03511664), which was a randomized (2:1), multicenter, open-label trial that assessed the efficacy and safety of 177Lu-PSMA-617 plus best standard of care (BSoC; n = 551) or BSoC alone (n = 280) in men with progressive, PSMA-positive mCRPC. Patients were required to have received ≥1 androgen receptor pathway inhibitor, and one or two prior taxane-based chemotherapy regimens. There was a statistically significant and clinically meaningful improvement in overall survival (OS), with a median OS of 15.3 months in the 177Lu-PSMA-617 plus BSoC arm and 11.3 months in the BSoC arm, respectively (HR: 0.62; 95% confidence interval: 0.52-0.74; P

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

Lutetium Lu 177 vipivotide tetraxetan for prostate cancer. [2023] On March 23, 2022, the U.S. Food and Drug Administration (FDA) approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan), also known as 177Lu-PSMA-617, for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) who have highly expressed prostate-specific membrane antigen (PSMA) and have at least one metastatic lesion. It is the first FDA-approved targeted radioligand therapy for eligible men with PSMA-positive mCRPC. Lutetium Lu 177 vipivotide tetraxetan is a radioligand that strongly binds to PSMA, making it ideal for treating cancers of the prostate by targeted radiation, resulting in DNA damage and cell death. PSMA is overexpressed in cancer cells while being lowly expressed in normal tissues, which makes it an ideal theranostic target. As precision medicine advances, this is a thrilling turning point for highly individualized treatments. This review aims to summarize the pharmacology and clinical studies of the novel drug lutetium Lu 177 vipivotide tetraxetan for the treatment of mCRPC, emphasizing its mechanism of action, pharmacokinetics and safety.