Lutetium Treatments for Prostate Cancer

No longer recruiting at 6 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new treatments using a radioactive substance called lutetium to target prostate cancer that has spread beyond the prostate gland. Researchers aim to evaluate the effectiveness of these treatments and compare their effects. The trial is for men whose prostate cancer cannot be cured with surgery or radiation and who have PSMA-positive cancer on scans. Participants should not have received certain treatments recently and must be able to undergo specific imaging scans. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

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.

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

Research has shown that both Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) have promising safety records from earlier studies.

Lutetium (177Lu) rhPSMA-10.1 was well-tolerated in early research. It delivered more radiation to tumors than to healthy tissues, indicating effective cancer targeting while minimizing harm to normal cells.

Lutetium (177Lu) Vipivotide Tetraxetan, or Pluvicto®, has FDA approval for treating prostate cancer, confirming its safety and effectiveness in other settings. In these studies, Pluvicto® improved survival rates and was generally well-tolerated by patients.

Overall, both treatments have demonstrated good safety data in earlier studies, suggesting they are relatively well-tolerated. However, like any treatment, side effects may occur, so discussing these with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) treatments for prostate cancer because they offer a novel approach by targeting prostate-specific membrane antigen (PSMA) on cancer cells. Unlike traditional treatments such as hormone therapy or chemotherapy, which can affect both healthy and cancerous cells, these lutetium-based therapies specifically aim to deliver radiation directly to cancer cells, potentially reducing side effects and improving effectiveness. This precision targeting is what sets them apart from current standard treatments and why they're generating so much interest in the medical community.

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

Research shows that both Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan (Pluvicto®) offer promise for treating advanced prostate cancer. In this trial, participants in Sequence A will receive Lutetium (177Lu) rhPSMA-10.1 first, followed by Lutetium (177Lu) Vipivotide Tetraxetan, while those in Sequence B will receive the treatments in reverse order. Lutetium (177Lu) rhPSMA-10.1 targets cancer cells with more radiation than healthy cells, potentially improving cancer targeting. Early results indicate that this treatment is generally well tolerated and may be effective. Studies on Lutetium (177Lu) Vipivotide Tetraxetan have found that it can extend patient survival and significantly reduce prostate-specific antigen (PSA) levels, a measure of prostate cancer activity. Specifically, one study showed that 55.6% of patients experienced at least a 50% drop in PSA levels, indicating a strong response to the treatment. ^{2 6 7 8 9}

Who Is on the Research Team?

Blue Earth Therapeutics

Principal Investigator

Blue Earth Therapeutics

Are You a Good Fit for This Trial?

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

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. 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%) ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.63

Patient characteristics and overall survival with lutetium (Lu ... The median OS from start of 177Lu-PSMA-617 therapy was 15.3 months (95% confidence interval [CI]: 14.6–16.3); a total of 137/643 (21.3%) ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2452109425002040

Lutetium Lu 177 Vipivotide Tetraxetan Efficacy and Toxicity ... 68.9% of the cohort observed PSA biomarker improvement of ≥10%, and 55.6% with ≥50% PSA reduction. Three patients (6.7%) achieved a complete ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/early/2025/09/25/jnumed.125.270704

First-Line [177Lu]Lu-PSMA-617 Therapy Without ADT ... In the phase 3 PSMAfore trial, [177Lu]Lu-PSMA-617 demonstrated significantly improved radiographic progression-free survival compared with an ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9099330/

Lutetium Lu 177 Vipivotide Tetraxetan: First Approval - PMC A >50% PSA reduction was seen in 27 of 50 patients (54%); median PSA PFS was 5.6 months and median OS was 15.2 months [35]. The efficacy of lutetium Lu 177 ...

6. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-14846-x

Adverse events associated with Lutetium-177-PSMA-617 ... Pluvicto® can bind to prostate cancer cells expressing prostate-specific membrane antigen and induce DNA damage through the radiation released ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10159870/

FDA Approval Summary: Lutetium Lu 177 Vipivotide ... The FDA granted approval based on a statistically significant and clinically meaningful improvement in overall survival when 177Lu-PSMA-617 was combined with ...

8. novartis.com novartis.com/clinicaltrials/study/nct05803941

Long-Term Safety of Lutetium (177Lu) Vipivotide ... The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan.

9. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.86

Real world outcomes in patients with metastatic castration ... 47 patients (71%) had an overall decline in their PSA from baseline, with 32 patients (49%) experiencing a decrease greater than fifty percent.