430 Participants Needed

177Lu-TLX591 for Advanced Prostate Cancer

Recruiting at 12 trial locations
Age: 18+
Sex: Male
Trial Phase: Phase 3
Sponsor: Telix Pharmaceuticals (Innovations) Pty Ltd
Must be taking: LHRH analogues
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with Androgen Receptor Pathway Inhibitor Treatment

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you should not have received certain treatments like chemotherapy or other investigational therapies within 4 weeks of enrollment. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment 177Lu-TLX591 for advanced prostate cancer?

Research on a similar treatment, Lutetium-177-PSMA-617, shows it can reduce prostate-specific antigen (PSA) levels and metastasis in advanced prostate cancer, suggesting potential effectiveness for 177Lu-TLX591 as well.12345

Is 177Lu-TLX591 safe for use in humans?

There is no specific safety data available for 177Lu-TLX591, but similar Lutetium-177 based treatments like 177Lu-PSMA-617 have been used safely in prostate cancer, with research focusing on optimizing safety and managing risks.46789

What makes the drug 177Lu-TLX591 unique for treating advanced prostate cancer?

177Lu-TLX591 is a novel radioligand therapy that targets prostate-specific membrane antigen (PSMA) on prostate cancer cells, similar to other treatments like 177Lu-PSMA-617, but it uses a different monoclonal antibody (rosopatamab) to deliver the radioactive lutetium-177, potentially offering a unique approach to targeting and treating advanced prostate cancer.24101112

Eligibility Criteria

This trial is for men over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread despite treatment. They should have had prior therapy with specific drugs, be in relatively good health (ECOG status 0-2), and have a life expectancy of at least 6 months. Men who've received certain treatments like docetaxel must meet additional time criteria since their last dose.

Inclusion Criteria

My cancer is PSMA-positive as shown by a specific scan.
My platelet count is at least 150,000 per microliter.
My cancer has spread or worsened, confirmed by scans.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

Safety and Dosimetry Lead-in

Initial phase to assess safety and dosimetry in 30 patients

Not specified

Randomized Treatment Expansion

Participants are randomized to receive either 177Lu-TLX591 with SOC or SOC alone

337 days

Long-term Follow-up

All patients will be followed for at least 5 years from the first therapeutic dose, death, or loss to follow-up

5 years

Treatment Details

Interventions

  • 177Lu-TLX591
Trial OverviewThe study tests the effectiveness and safety of a new drug, 177Lu-TLX591, combined with standard care versus standard care alone in patients whose prostate cancer has worsened after Androgen Receptor Pathway Inhibitor Treatment. Standard care includes drugs like Docetaxel, Enzalutamide, Abiraterone.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: 177Lu-TLX591 + Enzalutamide or Abiraterone or DocetaxelExperimental Treatment4 Interventions
Lutetium (177Lu) rosopatamab tetraxetan (177Lu-TLX591) 76 mCi (±10%) given approximately 14 days apart, plus SOC. SOC is either: Concurrent enzalutamide (starting dose 160 mg daily) + prednisone / prednisolone (5 mg twice a day) or equivalent. or Concurrent abiraterone (starting dose 1,000 mg daily) + prednisone / prednisolone (5 mg once daily for the standard formulation), methylprednisolone (4 mg twice daily for the fine particle formulation) or dexamethasone (1 mg once daily) or Sequential Docetaxel: Single agent chemotherapy will consist of docetaxel given at a recommended dose of 75mg/m2 IV every 3 weeks given in combination with oral prednisone / prednisolone (5mg twice a day) or equivalent for up to 10 cycles.
Group II: Control Arm (Enzalutamide or Abiraterone or Docetaxel)Active Control3 Interventions
SOC is either: Enzalutamide (starting dose 160 mg daily) + prednisone / prednisolone (5 mg twice a day) or equivalent. or Abiraterone (starting dose 1,000 mg daily) + prednisone / prednisolone (5 mg once daily for the standard formulation), methylprednisolone (4 mg twice daily for the fine particle formulation) or dexamethasone (1 mg once daily) or Docetaxel: Single agent chemotherapy will consist of docetaxel given at a recommended dose of 75mg/m2 IV every 3 weeks given in combination with oral prednisone / prednisolone (5mg twice a day) or equivalent for up to 10 cycles

Find a Clinic Near You

Who Is Running the Clinical Trial?

Telix Pharmaceuticals (Innovations) Pty Ltd

Lead Sponsor

Trials
3
Recruited
870+

Telix Pharmaceuticals (Innovations) Pty Limited

Lead Sponsor

Trials
23
Recruited
2,400+

Findings from Research

Treatment with lutetium-177 (177Lu)-prostate-specific membrane antigen (PSMA) significantly reduces prostate-specific antigen (PSA) levels in patients with advanced metastatic prostate cancer, especially after the first treatment cycle.
The therapy shows a beneficial effect on reducing lymph node metastasis, while also indicating potential negative impacts on visceral metastasis, highlighting its efficacy in managing certain aspects of the disease.
Treatment of Advanced Metastatic Prostate Cancer Using Molecular-Targeted Therapy: Radioligand Lutetium-177 Prostate-Specific Membrane Antigen.Rathore, R., Rangrej, SB., Kieme, I., et al.[2023]
In a phase I/II trial involving 20 men with high-risk localized prostate cancer, treatment with [177Lu]Lu-PSMA-617 delivered high radiation doses to tumors with minimal side effects, indicating its safety prior to surgery.
The treatment resulted in a significant PSA decline in 45% of patients, suggesting potential efficacy in reducing tumor burden before radical prostatectomy.
Administering [177Lu]Lu-PSMA-617 Prior to Radical Prostatectomy in Men with High-risk Localised Prostate Cancer (LuTectomy): A Single-centre, Single-arm, Phase 1/2 Study.Eapen, RS., Buteau, JP., Jackson, P., et al.[2023]
In a study of 52 patients undergoing Lu-177-PSMA-617 radioligand therapy for metastatic castration-resistant prostate cancer, the median overall survival was found to be 55.6 weeks, highlighting the treatment's potential efficacy.
Key predictors of overall survival included lower pre-therapeutic hemoglobin levels and higher lactate dehydrogenase (LDH) levels, as well as the presence of hepatic metastasis, indicating that these factors can help guide treatment decisions.
Pre- and intratherapeutic predictors of overall survival in patients with advanced metastasized castration-resistant prostate cancer receiving Lu-177-PSMA-617 radioligand therapy.Wrenger, R., Jüptner, M., Marx, M., et al.[2022]

References

Treatment of Advanced Metastatic Prostate Cancer Using Molecular-Targeted Therapy: Radioligand Lutetium-177 Prostate-Specific Membrane Antigen. [2023]
Administering [177Lu]Lu-PSMA-617 Prior to Radical Prostatectomy in Men with High-risk Localised Prostate Cancer (LuTectomy): A Single-centre, Single-arm, Phase 1/2 Study. [2023]
Pre- and intratherapeutic predictors of overall survival in patients with advanced metastasized castration-resistant prostate cancer receiving Lu-177-PSMA-617 radioligand therapy. [2022]
Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. [2023]
ENZA-p trial protocol: a randomized phase II trial using prostate-specific membrane antigen as a therapeutic target and prognostic indicator in men with metastatic castration-resistant prostate cancer treated with enzalutamide (ANZUP 1901). [2022]
Safety and Therapeutic Optimization of Lutetium-177 Based Radiopharmaceuticals. [2023]
Radiomics Analysis for 177Lu-DOTAGA-(l-y)fk(Sub-KuE) Targeted Radioligand Therapy Dosimetry in Metastatic Prostate Cancer-A Model Based on Clinical Example. [2021]
Phase 1/2 study of fractionated dose lutetium-177-labeled anti-prostate-specific membrane antigen monoclonal antibody J591 (177 Lu-J591) for metastatic castration-resistant prostate cancer. [2020]
Combined biology-guided radiotherapy and Lutetium PSMA theranostics treatment in metastatic castrate-resistant prostate cancer. [2023]
Pilot Study of Hyperfractionated Dosing of Lutetium-177-Labeled Antiprostate-Specific Membrane Antigen Monoclonal Antibody J591 (177 Lu-J591) for Metastatic Castration-Resistant Prostate Cancer. [2021]
Lutetium-177-PSMA-617 radioligand therapy in patients with high volume metastatic prostate cancer prior to chemotherapy and new generation androgen deprivation therapy: Clinical Experience. [2023]
Health-related quality of life and pain outcomes with [177Lu]Lu-PSMA-617 plus standard of care versus standard of care in patients with metastatic castration-resistant prostate cancer (VISION): a multicentre, open-label, randomised, phase 3 trial. [2023]