177Lu-PSMA with Biopsy for Prostate Cancer

Overseen By Ankush Sachdeva

Age: Any Age

Sex: Male

Trial Phase: Phase 1

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Bleeding disorders

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

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

Compensation: Varies

Number of Visits: 2

Duration: 2-4 weeks after cycle 2

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies how well a targeted radiation treatment works in patients with advanced prostate cancer that doesn't respond to hormone therapy. The treatment aims to kill cancer cells by delivering radiation directly to them.

Will I have to stop taking my current medications?

If you are taking warfarin, aspirin, or other blood thinners, you may need to stop them for one week before the biopsy. You might be able to switch to a different medication during this time, but this should be discussed with your doctor.

Is 177Lu-PSMA-617 safe for humans?

177Lu-PSMA-617, 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 targets cancer cells specifically, which helps minimize damage to normal cells, but like any treatment, it may have side effects. ^{1 2 3 4 5}

What makes the drug 177Lu-PSMA unique for prostate cancer?

177Lu-PSMA is unique because it is a radiopharmaceutical that specifically targets prostate-specific membrane antigen (PSMA) on cancer cells, delivering radiation directly to kill them, which is different from traditional chemotherapy that affects both cancerous and healthy cells. ^{1 2 3 4 6}

What data supports the effectiveness of the drug 177Lu-PSMA-617 for prostate cancer?

The drug 177Lu-PSMA-617 has been shown to improve survival in patients with advanced prostate cancer, as demonstrated in the VISION trial, where it increased overall survival from 11.3 months to 15.3 months compared to standard care alone. ^{1 2 3 4 6}

Who Is on the Research Team?

Johannes Czernin, MD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for men with advanced prostate cancer that no longer responds to hormone therapy and has spread. Participants must have a confirmed diagnosis, be willing volunteers, eligible for 177Lu-PSMA treatment, and have metastatic disease suitable for biopsy. They need adequate blood clotting function and may need to stop certain medications like blood thinners before the biopsy.

Inclusion Criteria

My prostate cancer diagnosis was confirmed through a tissue examination.

I can stop my blood thinners for a week before a biopsy, as agreed by my doctors.

Volunteer patient

Exclusion Criteria

I do not have a significant bleeding disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Biopsy

Participants undergo an image-guided biopsy at baseline to assess initial tumor characteristics

1 day

1 visit (in-person)

Treatment

Participants receive 177Lu-PSMA-617 therapy, with a follow-up biopsy 2-4 weeks after cycle 2

2-4 weeks after cycle 2

1 visit (in-person) for biopsy

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 177Lu-PSMA
• Image Guided Biopsy

Trial Overview The study is examining how well a targeted radioactive drug therapy (177Lu-PSMA) works by using image-guided biopsies on tumors. The goal is to understand why some cancers resist this treatment and use this information to improve future therapies.

How Is the Trial Designed?

Group I: Diagnostic (image-guided biopsy) Experimental Treatment 1 Intervention

Patients undergo an image-guided biopsy at baseline and 2-4 weeks after cycle 2 of 177Lu-PSMA-617 therapy.

177Lu-PSMA is already approved in United States, European Union for the following indications:

Approved in United States as Pluvicto for:

• Metastatic castration-resistant prostate cancer (mCRPC) after progressing on taxane-based chemotherapy and at least 1 line of androgen receptor pathway inhibitors (ARPIs)

Approved in European Union as Pluvicto for:

• Metastatic castration-resistant prostate cancer (mCRPC) after progressing on taxane-based chemotherapy and at least 1 line of androgen receptor pathway inhibitors (ARPIs)

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

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

2. England 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. [2023]

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

Lutetium Lu 177 Vipivotide Tetraxetan: First Approval. [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. United States pubmed.ncbi.nlm.nih.gov

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

6. Spain pubmed.ncbi.nlm.nih.gov

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