What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as 177Lu-PSMA Radioligand Therapy, often have side effects including myelosuppression (reduced bone marrow activity leading to lower blood cell counts), nephrotoxicity (kidney damage), and salivary gland toxicity (pain, swelling, and dry mouth). Other frequent side effects are nausea, fatigue, anemia, thrombocytopenia (low platelet count), and leukopenia (low white blood cell count). These treatments are generally well tolerated, but serious adverse effects can occur, particularly high-grade bone marrow suppression.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that are similar to 177Lu-PSMA Radioligand Therapy, which targets PSMA-expressing cells. One notable approval is for lutetium Lu 177 vipivotide tetraxetan, which demonstrated significant improvements in progression-free survival and overall survival in the VISION trial. This therapy is used for patients with PSMA-positive metastatic castration-resistant prostate cancer (CRPC) who have previously been treated with androgen-receptor pathway inhibitors and taxane-based chemotherapy. Additionally, radium-223 (Ra-223) has been approved for the treatment of CRPC with symptomatic bone metastases, showing benefits in overall survival and delayed skeletal-related events. These approvals highlight the growing role of targeted radiopharmaceuticals in managing advanced prostate cancer.

What other types of research exist?

Promising alternatives to 177Lu-PSMA Radioligand Therapy for prostate cancer patients include: <ol> <li>Radium-223 (Ra-223): An alpha particle-emitting agent that prolongs overall survival and decreases symptomatic skeletal-related events in men with castration-resistant prostate cancer (CRPC) with bone metastases.</li> <li></li> </ol> Abiraterone/Prednisone and Enzalutamide: Systemic therapies for metastatic CRPC that reduce skeletal-related events and improve bone pain and quality of life. 3. Docetaxel: A chemotherapy agent that, when combined with Ra-223, has shown more durable decreases in serum tumor markers and a lower rate of febrile neutropenia compared to docetaxel alone. 4. Beta-emitting radioisotopes: Strontium-89 and Samarium-153 have been used clinically and may offer benefits in specific cases. 5. External Beam Radiation Therapy (EBRT): Effective for bone pain not responsive to systemic therapy, particularly when limited to a few sites.

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Radiation

177Lu-PSMA with Biopsy for Prostate Cancer

Phase 1

Recruiting

Led By Johannes Czernin

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed prostate cancer

Evidence of lymph node or soft tissue metastatic disease amenable to image-guided biopsy based on positron emission tomography (PET)/computed tomography (CT) images

Must not have

Patients with significant congenital or acquired bleeding disorders (e.g. von Wildebrand's disease, acquired bleeding factor inhibitors) are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects of image-guided biopsies can include pain at the biopsy site, bleeding, infection risk, and reactions related to sedation or anesthesia used during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer diagnosis was confirmed through a tissue examination.

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My scans show cancer spread to lymph nodes or tissues that can be biopsied.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a significant bleeding disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (image-guided biopsy)Experimental Treatment1 Intervention

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

177Lu-PSMA Radioligand Therapy targets prostate-specific membrane antigen (PSMA) expressed on prostate cancer cells, delivering targeted radiation to kill these cells while sparing surrounding healthy tissue. This precision reduces side effects and improves treatment efficacy. Other common treatments include androgen deprivation therapy (ADT), which lowers testosterone levels to slow cancer growth, and chemotherapy, which uses drugs to kill rapidly dividing cells. Immunotherapy, such as sipuleucel-T, stimulates the immune system to attack cancer cells. Understanding these mechanisms helps patients and doctors choose the most appropriate treatment based on the cancer's characteristics and patient health.

Biomarkers to personalize treatment with 177Lu-PSMA-617 in men with metastatic castration-resistant prostate cancer - a state of the art review.

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

369 Previous Clinical Trials

29,399 Total Patients Enrolled

39 Trials studying Prostate Cancer

3,982 Patients Enrolled for Prostate Cancer

Johannes CzerninPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

2 Previous Clinical Trials

400 Total Patients Enrolled

Media Library

177Lu-PSMA (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT05398302 — Phase 1

Prostate Cancer Research Study Groups: Diagnostic (image-guided biopsy)

Prostate Cancer Clinical Trial 2023: 177Lu-PSMA Highlights & Side Effects. Trial Name: NCT05398302 — Phase 1

177Lu-PSMA (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05398302 — Phase 1

~20 spots leftby Dec 2025

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