Lutetium Treatments for Prostate Cancer

Recruiting at 5 trial locations

Overseen By Blue Earth Therapeutics

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: Blue Earth Therapeutics Ltd

Must not be taking: Radiopharmaceuticals

Disqualifiers: Metallic implants, Claustrophobia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not change your prostate cancer medication or start new prostate cancer treatments within 42 days before the screening or during the study. If you are on other medications, the protocol does not specify if you need to stop them.

What data supports the effectiveness of the drug Lutetium Lu 177 vipivotide tetraxetan for prostate cancer?

The drug Lutetium Lu 177 vipivotide tetraxetan has been shown to improve overall survival in patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer, as demonstrated in the VISION trial. Patients receiving this drug lived a median of 15.3 months compared to 11.3 months for those receiving standard care alone. ^{1 2 3 4 5}

Is Lutetium Lu 177 vipivotide tetraxetan safe for humans?

Lutetium Lu 177 vipivotide tetraxetan, also known as Pluvicto, has been approved by the FDA for treating certain prostate cancers, indicating it has been evaluated for safety. It targets cancer cells specifically, which helps minimize damage to normal tissues, but like all treatments, it may have side effects, and its safety was assessed in clinical trials. ^{1 2 3 4 5}

What makes Lutetium (177Lu) rhPSMA-10.1 treatment unique for prostate cancer?

Lutetium (177Lu) rhPSMA-10.1 is a novel treatment that targets prostate-specific membrane antigen (PSMA) on cancer cells, using a radioactive component, lutetium-177, to deliver targeted radiation directly to the cancer cells. This approach is particularly used for patients with metastatic castration-resistant prostate cancer who have already undergone other treatments like hormone therapy and chemotherapy. ^{1 5 6 7 8}

What is the purpose of this trial?

A randomised, multi-centre, intra-patient imaging and dosimetry crossover study of lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in patients with non-curative metastatic prostate cancer

Research Team

Blue Earth Therapeutics

Principal Investigator

Blue Earth Therapeutics

Eligibility Criteria

This trial is for men over 60 with non-curative metastatic prostate cancer that shows up on PET or CT scans. They must have good blood counts, liver function, and kidney health. Participants need to consent to study procedures and be planned for radioligand therapy.

Inclusion Criteria

I agree not to father a child or donate sperm during and for 14 weeks after the study.

Adequate normal organ function including: Absolute neutrophil count ≥1.5 × 10^9/L, Platelets ≥100 × 10^9/L, Haemoglobin ≥9 g/dL, Total bilirubin <2 × the institutional upper limit of normal (ULN) (≤3 × ULN permitted for patients with known Gilbert's Syndrome), ALT or AST ≤3.0 × ULN or ≤5.0 × ULN for patients with liver metastases, Estimated glomerular filtration rate >50 mL/min

Willing to provide signed and dated written informed consent form (ICF) prior to any study specific procedures

Exclusion Criteria

I haven't changed my prostate cancer treatment or had surgery in the last 42 days.

Known hypersensitivity to lutetium (177Lu) rhPSMA 10.1 or lutetium (177Lu) vipivotide tetraxetan, or any of the constituents

Any significant metallic implants or objects that may affect image quality and/or dosimetry calculations

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lutetium (177Lu) rhPSMA 10.1 and lutetium (177Lu) vipivotide tetraxetan in a crossover design

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Lutetium (177Lu) rhPSMA-10.1
• Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®)

Trial Overview The study compares two radioactive drugs: lutetium (177Lu) rhPSMA 10.1 and Pluvicto® in a crossover design, meaning patients will receive both treatments at different times to measure which one works better for their prostate cancer.

Participant Groups

Group I: Sequence B Experimental Treatment 1 Intervention

Patients in Sequence B will receive lutetium (177Lu) vipivotide tetraxetan followed by lutetium (177Lu) rhPSMA 10.1

Group II: Sequence A Experimental Treatment 1 Intervention

Patients in Sequence A will receive lutetium (177Lu) rhPSMA 10.1 followed by lutetium (177Lu) vipivotide tetraxetan

Who Is Running the Clinical Trial?

Blue Earth Therapeutics Ltd

Lead Sponsor

Trials

2

Recruited

110+

Medpace, Inc.

Industry Sponsor

Trials

98

Recruited

30,400+

Dr. August J. Troendle

Medpace, Inc.

Chief Executive Officer since 1992

MD from the University of Maryland, School of Medicine; MBA from Boston University

Dr. Reinilde Heyrman

Medpace, Inc.

Chief Medical Officer since 2017

MD

Findings from Research

Lutetium-177 prostate-specific membrane antigen radioligand therapy (Lu-177-PSMA-RLT) is emerging as a promising treatment for castration-resistant metastatic prostate cancer, utilizing the targeted delivery of the radionuclide Lutetium-177 to cancer cells expressing the prostate-specific membrane antigen.

There is currently no prospective randomized data on Lu-177-PSMA-RLT, which raises questions about its reimbursement by health insurance in Germany, highlighting the need for clarity on its integration into treatment plans for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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]. Ahmadzadehfar, H., Albers, P., Bockisch, A., et al.[2019]

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]

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]

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]

Lutetium-177 PSMA treatment is more likely to be effective in metastatic castration-resistant prostate cancer patients who have high baseline PSMA expression levels, particularly in bone lesions, as indicated by significant differences in SUVmax, PSMA TV, and TL PSMA values after treatment.

The study identified specific cutoff values for predicting treatment response, with a sensitivity of 91.8% for SUVmax greater than 10.50, suggesting that these parameters can help clinicians determine which patients are more likely to benefit from Lu177 PSMA therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of Ga68 PSMA PET/CT imaging in Lu177 PSMA treatment planning in metastatic castration-resistant prostate cancer. Erdogan, M., Sengul, SS., Cetin, B., et al.[2022]

Lutetium-177 coupled with a ligand for Prostate Specific Membrane Antigen ([177Lu]Lu-PSMA) is an innovative treatment for patients with advanced prostate cancer who have limited options after hormonal therapy and chemotherapy, requiring specific eligibility criteria including good health and adequate targeting of metastases.

The treatment involves four to six intravenous doses administered six weeks apart, with mild side effects such as dry mouth, fatigue, and bone marrow depression, and is currently available in select hospitals in the Netherlands, with broader access expected following EMA registration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Lutetium-177-PSMA in metastasized prostate carcinoma]. van Golen, LW., Vogel, W., Lam, MGEH.[2023]

Lutetium-177 coupled with a ligand for Prostate Specific Membrane Antigen ([177Lu]Lu-PSMA) is an innovative treatment for patients with advanced prostate cancer who have limited options after hormonal therapy and chemotherapy, requiring specific eligibility criteria including good health and adequate targeting of metastases.

The treatment involves four to six intravenous doses administered six weeks apart, with mild side effects such as dry mouth, fatigue, and bone marrow depression, and is currently available in select hospitals in the Netherlands, with broader access expected following EMA registration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Lutetium-177-PSMA in metastasized prostate carcinoma]. van Golen, LW., Vogel, W., Lam, MGEH.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[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]

2. Spain pubmed.ncbi.nlm.nih.gov

Lutetium Lu 177 vipivotide tetraxetan for prostate cancer. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

New Drug for Metastatic Castration-Resistant Prostate Cancer. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Lutetium Lu 177 Vipivotide Tetraxetan: First Approval. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

The role of Ga68 PSMA PET/CT imaging in Lu177 PSMA treatment planning in metastatic castration-resistant prostate cancer. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

[Lutetium-177-PSMA in metastasized prostate carcinoma]. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

[Lutetium-177-PSMA in metastasized prostate carcinoma]. [2023]