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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat prostate cancer that has returned after surgery. It combines two treatments: a targeted radioactive drug, Lutetium Lu 177 PSMA-10.1, which directly attacks cancer cells, and radiation therapy, which uses high-energy rays to kill cancer cells. The trial aims to assess the safety of this combination and determine the optimal dose. Men who have undergone prostate surgery and now experience rising PSA levels, indicating cancer recurrence, might consider participating. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that 177Lu-rhPSMA-10.1, a type of targeted radiation therapy, is generally well-tolerated. In studies, this treatment produced promising results. Many patients experienced a significant drop in their prostate-specific antigen (PSA) levels, which can indicate cancer activity. Importantly, most patients did not suffer severe side effects. This suggests that 177Lu-rhPSMA-10.1 could be a safe option for those with recurring prostate cancer after surgery. However, as this trial is in an early stage, ongoing studies aim to confirm these findings and determine the best dose.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Lutetium Lu 177 PSMA-10.1 with radiation therapy for prostate cancer because it targets cancer cells more precisely. Unlike traditional treatments like chemotherapy or hormone therapy, which can affect both healthy and cancerous cells, this approach uses a radioactive compound that binds specifically to the prostate-specific membrane antigen (PSMA) found on cancer cells. This precision allows for targeted radiation delivery, potentially leading to fewer side effects and more effective tumor reduction. Additionally, the integration of advanced imaging techniques, such as PET/CT and SPECT-CT, enhances the ability to monitor treatment response, providing a clearer picture of its effectiveness.

What evidence suggests that this trial's treatments could be effective for recurrent prostate cancer?

Research has shown that 177Lu-rhPSMA-10.1, administered alongside External Beam Radiation Therapy (EBRT) in this trial, can significantly slow tumor growth. Studies have found that it targets prostate cancer cells by delivering radiation directly to the tumor, while mostly sparing healthy tissues. In patients with advanced prostate cancer, this treatment significantly lowered levels of prostate-specific antigen, a marker used to monitor the cancer. The treatment effectively balances attacking the tumor and protecting healthy organs, offering promise for controlling cancer. Overall, these findings suggest that 177Lu-rhPSMA-10.1 could be a viable option for treating prostate cancer that recurs after surgery.13678

Who Is on the Research Team?

DM

David M. Schuster, MD

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (EBRT, 177Lu-rhPSMA-10.1)Experimental Treatment7 Interventions

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:
🇪🇺
Approved in European Union as Pluvicto for:

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+

Published Research Related to This Trial

Lutetium-177 PSMA radioligand therapy shows a significant response rate in treating metastatic castration-resistant prostate cancer, with 56% of patients experiencing a PSA decline of 50% or more, indicating its efficacy as a treatment option.
The therapy has a low toxicity profile, with serious adverse events occurring in a small percentage of patients, and is particularly effective in those with lymph node metastases and lower baseline PSA levels, suggesting these factors can help predict better survival outcomes.
Real-World Data Analysis of Efficacy and Survival After Lutetium-177 Labelled PSMA Ligand Therapy in Metastatic Castration-Resistant Prostate Cancer.Meyrick, D., Gallyamov, M., Sabarimurugan, S., et al.[2021]
In an 18-month study involving 50 patients with metastatic castration-resistant prostate cancer (mCRPC), 44.9% experienced a significant decline in prostate-specific antigen (PSA) levels of 50% or more after receiving up to four cycles of Lutetium-177-PSMA (LuPSMA) therapy.
The treatment was found to be safe, with most adverse events being mild (grade I), indicating that LuPSMA could be a promising option for patients who have exhausted other treatments.
Lu177-PSMA therapy for men with advanced prostate cancer: Initial 18 months experience at a single Australian tertiary institution.McBean, R., O'Kane, B., Parsons, R., et al.[2020]
The new 211At-labeled radiotracer, 211At-3-Lu, effectively targets prostate-specific membrane antigen (PSMA) in prostate cancer cells, showing significant uptake in PSMA+ tumors with minimal uptake in non-target cells, indicating its potential for targeted therapy.
In a long-term toxicity study, 211At-3-Lu demonstrated low off-target toxicity and favorable safety profiles, including stable hematopoietic function and positive histopathological outcomes, suggesting it could be a safe and effective treatment option for patients with prostate cancer resistant to other therapies.
An Improved 211At-Labeled Agent for PSMA-Targeted α-Therapy.Mease, RC., Kang, CM., Kumar, V., et al.[2022]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40049746/
Preclinical Evaluation of 177 Lu-rhPSMA-10.1, a ...When efficacy was evaluated, 177Lu-rhPSMA-10.1 significantly suppressed tumor growth versus vehicle from day 11 (P < 0.05) in LNCaP xenografts ...
Preclinical Evaluation of 177 Lu-rhPSMA-10.1, a ...Our data showed 177Lu-rhPSMA-10.1 to significantly reduce tumor growth in a dose-dependent manner, with even 15 MBq of 177Lu-rhPSMA-10.1 ...
177Lu rhPSMA-10.1 Injection Generates Favorable ...177Lu rhPSMA-10.1 injection led to proportionally higher absorbed radiation doses in tumors vs healthy tissues in patients with mCRPC.
177Lu-rhPSMA-10.1 injection shows positive radiation ...The results demonstrated a favorable ratio between radiation doses absorbed in the tumor vs the doses delivered to key healthy organs.
5.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38164586/
First Safety and Efficacy Data with the Radiohybrid 177Lu- ...Results: The patients received a total activity of 29.6-59.4 GBq (4-6 cycles). Prostate-specific antigen was reduced by 100%, 99%, 88%, and 35%.
First Safety and Efficacy Data with the Radiohybrid 177Lu ...Our data show that 177Lu-rhPSMA-10.1 was well tolerated and induced a profound PSA response in 3 of 4 patients, with a smaller PSA response in ...
Organ and tumour dosimetry of 177Lu-rhPSMA-10.1, a novel ...First safety and efficacy data with the radiohybrid 177Lu-rhPSMA-10.1 for the treatment of metastatic prostate cancer. J Nucl Med. 2024;65 ...
Phase 1 data show encouraging safety of 177Lu-rhPSMA- ...Lutetium ( 177 Lu) rhPSMA-10.1 injection demonstrated promising radiation dosimetry results in patients with metastatic castration-resistant prostate cancer ( ...
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