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 explores the effectiveness of 177Lu-PSMA, a targeted radioligand therapy, for prostate cancer that has spread and resists standard hormone therapies. Researchers aim to understand why some prostate cancers resist this treatment by using image-guided biopsies to take tissue samples. They focus on patients with confirmed prostate cancer and visible signs of cancer spread in scans. This trial could help doctors plan better treatments for advanced prostate cancer in the future. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new therapy.

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 there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that 177Lu-PSMA treatments are generally well-tolerated by patients. Studies have found this therapy safe for treating advanced prostate cancer that no longer responds to hormone therapy. Patients who received 177Lu-PSMA reported manageable side effects, such as mild to moderate tiredness, dry mouth, and nausea.

Additionally, the FDA approved 177Lu-PSMA-617 for similar conditions, indicating it meets safety standards. While side effects can occur, they are usually not severe and are expected with this type of treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about 177Lu-PSMA because it represents a promising new approach to treating prostate cancer by targeting a specific protein called PSMA, which is abundant on prostate cancer cells. Unlike conventional treatments such as hormone therapy, chemotherapy, or surgery, 177Lu-PSMA works by delivering a radioactive particle directly to the cancer cells, potentially reducing damage to healthy tissues. This targeted therapy approach could lead to more effective treatment outcomes and fewer side effects, making it a significant advancement over existing options.

What evidence suggests that 177Lu-PSMA might be an effective treatment for prostate cancer?

Research shows that 177Lu-PSMA holds promise for treating metastatic castration-resistant prostate cancer (mCRPC), a type of prostate cancer that has spread and does not respond to hormone therapy. One study found that 177Lu-PSMA helped patients live longer without their cancer worsening, compared to those on hormone therapy. Another study showed that it delayed disease progression. Additionally, this treatment effectively and safely targets cancer cells. In this trial, participants will receive 177Lu-PSMA therapy, and some will undergo an image-guided biopsy to further evaluate the treatment's impact. These findings suggest that 177Lu-PSMA could be a strong option for patients with advanced prostate cancer. ^{1 2 4 6 7}

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

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]

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]

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 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]

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]

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]

Citations

1. onclive.com onclive.com/view/177lu-psma-i-t-meets-rpfs-end-point-in-psma-mcrpc

177Lu-PSMA-I&T Meets rPFS End Point in PSMA+ mCRPC 177Lu-PSMA-I&T improved radiographic progression-free survival vs hormonal therapy in PSMA-positive metastatic castration-resistant prostate cancer.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11599357/

Efficacy and safety of rechallenge with [177Lu]Lu-PSMA- ... The purpose of this study was to evaluate the safety and outcome of rechallenge [ 177 Lu]Lu-PSMA-I&T in newly progressed mCRPC patients.

3. targetedonc.com targetedonc.com/view/177lu-psma-i-t-shows-pfs-benefit-in-mcrpc

177Lu-PSMA-I&T Shows PFS Benefit in mCRPC The study demonstrated a statistically significant and clinically meaningful improvement in median radiographic progression-free survival (rPFS)

4. curiumpharma.com curiumpharma.com/2024/11/13/eclipse-tiral-psma-prostate-cancer/

Curium Announces ECLIPSE Trial Has Met Primary ... Curium's ECLIPSE trial shows significant benefits for PSMA-positive metastatic castration-resistant prostate cancer patients.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10043144/

Improved quality control of [177Lu]Lu-PSMA I&T - PMC Targeted radionuclide therapy with [177Lu]Lu-PSMA I&T (zadavotide guraxetan) has proven high efficacy and safety in treating patients with ...

6. ejnmmipharmchem.springeropen.com ejnmmipharmchem.springeropen.com/articles/10.1186/s41181-023-00191-6

Improved quality control of [ 177 Lu]Lu-PSMA I&T Targeted radionuclide therapy with [177Lu]Lu-PSMA I&T (zadavotide guraxetan) has proven high efficacy and safety in treating patients with ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36469000/

FDA Approval Summary: Lutetium Lu 177 Vipivotide ... - PubMed This article summarizes the FDA review of data supporting traditional approval of 177Lu-PSMA-617 for this indication. ©2022 American Association ...