10 Participants Needed

Radioligand + Radiation Therapy for Prostate Cancer

DM
AB
Overseen ByAshesh B. Jani, MD, MSEE, FASTRO
Age: 18+
Sex: Male
Trial Phase: Phase 1
Sponsor: Emory University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Radioligand + Radiation Therapy for Prostate Cancer?

Research shows that Lutetium-177 (Lu-177) radioligand therapy, which targets prostate-specific membrane antigen (PSMA), is promising for treating metastatic castration-resistant prostate cancer. Studies indicate it can reduce prostate-specific antigen (PSA) levels and metastasis, suggesting it may be effective in managing advanced prostate cancer.12345

Is the combination of radioligand and radiation therapy generally safe for humans?

Studies on Lutetium-177 PSMA radioligand therapy, used for prostate cancer, suggest it is generally safe, with some potential kidney-related concerns due to how the body processes the treatment. However, it has been used safely in patients with normal kidney function and even in those with a single functioning kidney.12678

How is the drug Lutetium Lu 177 PSMA-10.1 different from other treatments for prostate cancer?

Lutetium Lu 177 PSMA-10.1 is a new type of radioligand therapy that targets a specific protein on prostate cancer cells, potentially offering better treatment outcomes for patients with advanced prostate cancer that has not responded to other therapies. It is designed to improve upon existing treatments by optimizing how the drug behaves in the body, which may lead to more effective tumor responses.123910

What is the purpose of this trial?

This phase I trial tests the safety, side effects and best dose of radioligand therapy (lutetium Lu 177 PSMA-10.1 \[177Lu-rhPSMA-10.1\]) after prostate specific membrane antigen (PSMA) positron emission tomography (PET)-guided external beam radiotherapy in treating post-prostatectomy patients with prostate cancer that has come back after a period of improvement (recurrent). In this study, radioligand therapy is a radioactive drug called 177Lu-rhPSMA-10.1. It works by binding to PSMA-expressing prostate tumor cells and delivering the radioactive portion of the drug directly to the tumor cells while not harming normal cells. Radiation therapy such as external beam radiotherapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radioligand therapy with PSMA PET-guided external beam radiotherapy may kill more tumor cells in post-prostatectomy patients with biochemically recurrent prostate cancer.

Research Team

DM

David M. Schuster, MD

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Eligibility Criteria

Men over 18 with prostate cancer that has returned after surgery, who have detectable PSA levels and only show signs of cancer in the pelvic area on PSMA PET/CT scans. They should be relatively fit (ECOG status 0-2) and not have had prior radiotherapy or conditions like inflammatory bowel disease, severe kidney issues, high-risk urinary retention, significant liver damage, low blood counts, or serious acute illnesses.

Inclusion Criteria

I had surgery for prostate cancer and my PSA levels are now detectable.
I can take care of myself and am up and about more than half of the day.
I am over 18 years old.
See 1 more

Exclusion Criteria

Platelet count less than 75 x 10^9 /L
Liver enzymes > 5-fold ULN
Total white cell count less than 2.5 x 10^9 /L
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Radiation

Participants undergo external beam radiation therapy (EBRT) guided by PSMA PET

4-6 weeks
Multiple visits (in-person)

Radioligand Therapy

Participants receive 177Lu-rhPSMA-10.1 intravenously

6 weeks
Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks
1 visit (in-person)

Treatment Details

Interventions

  • External Beam Radiation Therapy
  • Lutetium Lu 177 PSMA-10.1
Trial Overview This phase I trial is testing a new radioactive drug called lutetium Lu 177 PSMA-10.1 after external beam radiation therapy guided by PSMA PET scans. The goal is to find the safest dose that can effectively target tumor cells without harming normal ones in patients whose prostate cancer has come back post-surgery.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (EBRT, 177Lu-rhPSMA-10.1)Experimental Treatment7 Interventions
Patients undergo EBRT followed by 177Lu-rhPSMA-10.1 IV on study. Patients also receive rhPSMA-7.3 IV with PET/CT at screening and undergo SPECT-CT and collection of blood samples on study.

Lutetium Lu 177 PSMA-10.1 is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Pluvicto for:
  • PSMA-positive metastatic castration-resistant prostate cancer
🇪🇺
Approved in European Union as Pluvicto for:
  • PSMA-positive metastatic castration-resistant prostate cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

177 Lu-rhPSMA-10.1 is a new radiopharmaceutical designed to target PSMA, showing promise in treating metastatic castrate-resistant prostate cancer, particularly in patients who have not responded to previous therapies.
In a case study of an 86-year-old man, switching to 177 Lu-rhPSMA-10.1 after initial treatment failure led to a renewed tumor response, suggesting its potential efficacy in difficult-to-treat cases.
177 Lu-rhPSMA-10.1 Induces Tumor Response in a Patient With mCRPC After PSMA-Directed Radioligand Therapy With 177 Lu-PSMA-I&T.Bundschuh, RA., Pfob, CH., Wienand, G., et al.[2023]
In a study of 84 Asian patients with metastatic castration-resistant prostate cancer (mCRPC) receiving Lutetium-177 PSMA radioligand therapy, the median overall survival was 12.2 months and the median PSA progression-free survival was 5.2 months, indicating promising efficacy.
A significant 51.8% of patients experienced a PSA decline of 50% or more, which was linked to longer overall survival and PSA progression-free survival, while the treatment showed a manageable safety profile with grade 3 hematotoxicity occurring in 13 out of 78 patients.
Outcomes and prognostic predictors of Lu-177 PSMA radioligand therapy in metastatic castration-resistant prostate cancer (Asian Population Study).Chua, WM., Lam, WW., Tong, AK., et al.[2023]
In a study of 71 patients with metastatic castration-resistant prostate cancer, 56% experienced a significant PSA decline of 50% or more after receiving three cycles of Lutetium-177 labeled PSMA-617 radioligand therapy, indicating its efficacy as a treatment option.
The therapy demonstrated delayed responses, as 28 out of 30 patients who responded after the first cycle continued to show positive results, and 12 out of 41 initial non-responders responded to subsequent cycles, highlighting the potential for ongoing therapeutic benefits.
Delayed response after repeated 177Lu-PSMA-617 radioligand therapy in patients with metastatic castration resistant prostate cancer.Rahbar, K., Bögeman, M., Yordanova, A., et al.[2021]

References

177 Lu-rhPSMA-10.1 Induces Tumor Response in a Patient With mCRPC After PSMA-Directed Radioligand Therapy With 177 Lu-PSMA-I&T. [2023]
Outcomes and prognostic predictors of Lu-177 PSMA radioligand therapy in metastatic castration-resistant prostate cancer (Asian Population Study). [2023]
Delayed response after repeated 177Lu-PSMA-617 radioligand therapy in patients with metastatic castration resistant prostate cancer. [2021]
Uptake of PSMA-ligands in normal tissues is dependent on tumor load in patients with prostate cancer. [2018]
Treatment of Advanced Metastatic Prostate Cancer Using Molecular-Targeted Therapy: Radioligand Lutetium-177 Prostate-Specific Membrane Antigen. [2023]
Lu177-PSMA therapy for men with advanced prostate cancer: Initial 18 months experience at a single Australian tertiary institution. [2020]
An Improved 211At-Labeled Agent for PSMA-Targeted α-Therapy. [2022]
Lutetium-177 Prostate Specific Membrane Antigen Therapy in a Patient With Double Malignancy and Single Functioning Kidney: A Case Report. [2023]
[Lutetium-177-PSMA radioligand therapy : Consensus within the framework of GKV-funded care between the university hospitals in Aachen, Bonn, Düsseldorf, Essen, and Cologne and the MDK Nordrhein]. [2019]
Real-World Data Analysis of Efficacy and Survival After Lutetium-177 Labelled PSMA Ligand Therapy in Metastatic Castration-Resistant Prostate Cancer. [2021]
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