AAA617 Alone or Combined With ARPI for Prostate Cancer

(PSMACare Trial)

Recruiting at39 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Novartis Pharmaceuticals

Must be taking: GnRH agonists/antagonists

Must not be taking: Second-gen anti-androgens, CYP17 inhibitors

Disqualifiers: Metastatic disease, Cardiac disease, Seizure, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new radioactive drug called AAA617, alone or with hormone-blocking medication, in men with a specific type of prostate cancer that hasn't spread and doesn't respond to usual treatments. The drug aims to kill cancer cells with radiation while the hormone blocker stops their growth.

Do I need to stop my current medications to join the trial?

The trial requires that you continue ongoing androgen deprivation therapy. You must stop using certain medications like estrogens, 5-α reductase inhibitors, and first-generation anti-androgens at least 28 days before joining the trial.

What data supports the effectiveness of the drug AAA617 for prostate cancer?

The drug Lutetium Lu 177 vipivotide tetraxetan, also known as Pluvicto, has been shown to improve survival in patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. In a clinical trial, patients receiving this drug lived longer on average compared to those who did not receive it. ^{1 2 3 4 5}

What safety data exists for Lutetium Lu 177 vipivotide tetraxetan in humans?

Lutetium Lu 177 vipivotide tetraxetan, also known as Pluvicto, has been approved by the FDA for treating certain prostate cancers, indicating it has undergone safety evaluations. It was tested in a large clinical trial (VISION trial) where it was generally well-tolerated, but like all treatments, it may have side effects, and its safety profile was considered acceptable for its intended use. ^{1 2 3 4 5}

What makes the drug AAA617 unique for treating prostate cancer?

AAA617, also known as Lutetium Lu 177 vipivotide tetraxetan, is unique because it is the first FDA-approved targeted radioligand therapy for prostate cancer that specifically binds to prostate-specific membrane antigen (PSMA) on cancer cells, delivering targeted radiation to kill them while sparing most 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 advanced prostate cancer that hasn't spread according to scans, but shows up on a special PSMA PET scan. They must be on hormone therapy or have had surgery to lower testosterone and have a rising PSA level indicating the cancer is growing despite treatment.

Inclusion Criteria

It seems like the criterion "Key" might be incomplete. Can you please provide more context or details so that I can accurately summarize it for you?

My testosterone levels are very low due to treatment or surgery.

You must agree and sign a form that explains the study before you can join.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 7.4 GBq (+/- 10%) of AAA617 once every 6 weeks for 6 cycles

36 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 5 years

Treatment Details

Interventions

• AAA617 (Radioisotope Therapy)
• ARPI (Androgen Receptor Pathway Inhibitor)

Trial Overview The study tests AAA617 alone and combined with ARPI drugs in men whose prostate cancer can be seen on a PSMA PET scan but not regular imaging. It checks if these treatments can control the cancer without it appearing elsewhere in the body.

Participant Groups

Group I: Arm B Experimental Treatment 6 Interventions

Participants will receive 7.4 GBq (+/- 10%) of AAA617 (Lutetium \[177Lu\] vipivotide tetraxetan) once every 6 weeks for 6 cycles. In addition of SOC (ADT plus choice of ARPI as per physician's decision), Best supportive care is allowed.

Group II: Arm A Experimental Treatment 5 Interventions

Participants will receive 7.4 GBq (+/- 10%) of AAA617 (Lutetium \[177Lu\] vipivotide tetraxetan) once every 6 weeks for 6 cycles. ADT must be ongoing; Best supportive care is allowed.

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

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]

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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Lutetium Lu 177 vipivotide tetraxetan for prostate cancer. [2023]

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

Lutetium Lu 177 Vipivotide Tetraxetan: First Approval. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Lutetium Lu 177 vipivotide tetraxetan for metastatic castration-resistant prostate cancer. [2023]

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

New Drug for Metastatic Castration-Resistant Prostate Cancer. [2022]

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

FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer. [2023]