Lu-177 PSMA for Prostate Cancer

Overseen By Guofan Xu, MD

Age: Any Age

Sex: Male

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must be taking: Pluvicto

Disqualifiers: Women, Children, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Varies based on personalized radiation dose

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the absorption of Lu-177 PSMA, a treatment for prostate cancer, in tumors and organs. It targets patients approved for Pluvicto therapy who have kidney issues or bone marrow dysfunction. Those with a history of prostate cancer treatment and impaired kidney or bone marrow function may find this trial suitable. Participants must agree to multiple imaging sessions as part of the study. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance treatment options for patients with specific health challenges.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Lu-177 PSMA is safe for prostate cancer patients?

Research has shown that Lu-177 PSMA, a treatment for prostate cancer, is generally well-tolerated by patients. One study found that combining this therapy with standard care extended patients' lives compared to standard care alone, indicating its safety when used as directed. Another study demonstrated that patients could safely undergo up to six cycles of this treatment. These findings support its use, though researchers continue to study long-term safety to better understand potential side effects. Overall, current evidence suggests that Lu-177 PSMA is safe for most patients, but discussing any concerns with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Lu-177 PSMA is unique because it directly targets prostate-specific membrane antigen (PSMA), a protein found in high amounts on prostate cancer cells. Unlike traditional treatments like surgery, radiation, or chemotherapy that can affect both cancerous and healthy cells, Lu-177 PSMA delivers radiation precisely to cancer cells, minimizing damage to healthy tissues. Researchers are excited about this treatment because it offers a more targeted approach, potentially leading to fewer side effects and improved outcomes for patients with prostate cancer.

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

Research has shown that Lu-177 PSMA, the treatment evaluated in this trial, effectively treats prostate cancer, particularly when other treatments fail. One study found that adding Lu-PSMA-617 to standard care significantly increased the time patients lived without cancer progression. Another study demonstrated that many patients responded well to the treatment, with tumors shrinking or being controlled. Additionally, patients who received this therapy lived for more than 15 months on average. These findings suggest that Lu-177 PSMA can be a strong option for managing advanced prostate cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Guofan Xu, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for men with prostate cancer who are approved for Pluvicto therapy but have kidney issues (with specific GFR and creatinine levels) or bone marrow problems (defined by white blood cell and platelet counts). They must be willing to undergo multiple imaging sessions. Women, children, and patients without these complications cannot participate.

Inclusion Criteria

Participants who agree to be imaged multiple times as defined in the study protocol

I am approved for Pluvicto with specific kidney or blood cell count issues.

Exclusion Criteria

I am on Pluvicto therapy without kidney or bone marrow issues.

I do not want to undergo multiple imaging tests for the study.

This does not apply to me as the treatment is for prostate cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive targeted radionuclide therapy of Lu-177 PSMA

Varies based on personalized radiation dose

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Lu-177 PSMA

Trial Overview The study tests how much of the Pluvicto dose is absorbed in tumors and organs of patients with compromised kidney or bone marrow function using Lu-177 targeted radionuclide therapy along with SPECT imaging to track the treatment's distribution.

How Is the Trial Designed?

Group I: Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

GE Healthcare

Industry Sponsor

Trials

307

Recruited

634,000+

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2107322

Lutetium-177–PSMA-617 for Metastatic Castration ... Lu-PSMA-617 plus standard care significantly prolonged, as compared with standard care, both imaging-based progression-free survival (median, 8.7 vs. 3.4 months ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9803619/

Therapeutic Outcomes of 177Lu-PSMA Targeted Therapy ... The outcomes of 177Lu-PSMA targeted therapy have demonstrated an acceptable response rate in the metastatic castration-resistant prostate cancer (mCRPC) (5).

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.97

Real world outcomes of 177 Lu-PSMA-617 ... The cohort completed a median number of 4 cycles of 177Lu-PSMA-617; 35.7% completed six cycles. The overall cohort had a 12-month survival of ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251923

Outcomes of [177Lu] Lu-PSMA-617 Re-Treatment in ... Results: A total of 589 patients underwent [177Lu] Lu-PSMA-617 RLT, of whom 20 (3.4%, 20/589) received RLT retreatment. The median age was 71.3 ...

5. urotoday.com urotoday.com/conference-highlights/asco-gu-2025/asco-gu-2025-prostate-cancer/158159-asco-gu-2025-patient-characteristics-and-overall-survival-with-lutetium-lu177-vipivotide-tetraxetan-177lu-psma-617-a-real-world-analysis-of-early-adopters.html

Patient characteristics and overall survival with lutetium ... The median overall survival from the start of ¹⁷⁷Lu-PSMA-617 therapy was 15.3 months (95% CI: 14.6–16.3), with 137 of 643 patients (21.3%) ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40752988/

Outcomes for [ 177 Lu]Lu-PSMA-617 with and Without ... Key findings and limitations: Among 256 patients, 106 (41.4%) received an ARPI with [177Lu]Lu-PSMA-617. Those receiving an ARPI had lower ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.TPS294

Long-term safety outcomes of 177Lu-PSMA-617 in patients ... It is important to further characterize long-term safety outcomes in 177 Lu-PSMA-617–treated patients, with particular regard to potential treatment-related ...

8. annalsofoncology.org annalsofoncology.org/article/S0923-7534(25)00852-X/fulltext

Final overall survival and safety analyses of the phase III ... At the time of the final OS analysis, 299 deaths were reported in 142/234 participants (60.7%) in the 177Lu-PSMA-617 arm and 157/234 (67.1%) in ...

9. jnm.snmjournals.org jnm.snmjournals.org/content/65/6/909

Safety and Efficacy of Extended Therapy with [177Lu]Lu-PSMA Prospective results have demonstrated favorable safety and efficacy of [ 177 Lu]Lu-PSMA radiopharmaceutical therapy for up to 6 cycles in men with metastatic ...