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NCT Number: NCT05613738

177Lu-PSMA-EB-01 in Patients With Metastatic Castration-resistant Prostate Cancer

This is a pilot study to assess the safety and measure image-based absorbed dose of 177Lu-PSMA-EB-01, a new PSMA-specific radiopharmaceutical, in patients with metastatic castration resistant prostate cancer (mCRPC) who will undergo radioligand therapy (RLT). All patients underwent 68Ga-PSMA and 18F-FDG PET/CT for selection and were randomly divided into three groups of 3 people each.The three groups received an approximately 1.11 GBq (30mCi), 1.85 GBq (50 mCi) and 2.59 GBq (70mCi) of 177Lu-PSMA-EB-01 up to 2 cycles, respectively.

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Key information

Conditions

Metastatic Castration-resistant Prostate Cancer

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Prostate cancer is the most frequent malignant tumor in men worldwide. Prostate-specific membrane antigen (PSMA), is a surface molecule specifically expressed by prostate tumors which was shown to be a valid target for radiotherapy. 177Lu-PSMA-617, a urea-based compound, provide an effective target for the treatment of metastatic castration-resistant prostate cancer. However, a major problem in the therapeutic use of 177Lu-PSMA-617 has been its short half-life and fast rate of clearance. The investigators designed and synthesized a new radiopharmaceutical, named 177Lu-PSMA-EB-01. EB（Evans Blue）can bind to albumin to slow down its plasma clearance rate, thereby increasing tumor accumulation and reducing the total dosage of Lu-177. Hence, EB-PSMA-01 may be an option for consideration due to limited supply of Lu-177, by which more patients may be benefited by this version of 177Lu-EB-PSMA-01. This study was designed to investigate the safety, dosimetry and preliminary effects of 177Lu-EB-PSMA-01 in patients with metastatic castration resistant prostate cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • progressive metastatic castration-resistant prostate cancer
  • tumors with high PSMA expression confirmed on 68Ga-PSMA PET/CT

Exclusion criteria

  • a serum creatinine level of more than 150 μmol per liter
  • a hemoglobin level of less than 10.0 g/dl
  • a white-cell count of less than 4.0× 109/L
  • a platelet count of less than 100 × 109/L
  • a total bilirubin level of more than 3 times the upper limit of the normal range
  • a serum albumin level of more than 3.0 g per deciliter
  • cardiac insufficiency

Treatment and study plan

1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01

Drug

All patients were intravenous injected with single dose 1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours post-injection.

1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01

Drug

All patients were intravenous injected with single dose 1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours post-injection.

2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01

Drug

All patients were intravenous injected with single dose 2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours post-injection.

Primary outcomes

  1. Dosimetry of normal organs and tumors

    Time frame: through study completion, an average of 4 weeks

    The semiquantitative dosimetry will be performed based on SPECT/CT acquisitions after the first administration of 177Lu-PSMA-EB-01. The dose delivered to normal organs and tumors will be recorded.

  2. Hematologic adverse events collection

    Time frame: through study completion, an average of 6 months

    Hematologic status were performed before and every 2 weeks after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0

  3. Hepatic and renal toxic events collection

    Time frame: through study completion, an average of 6 months

    Liver function, and renal function were performed before and 4 weeks after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.

Secondary outcomes

  1. PSA Response

    Time frame: through study completion, an average of 6 months

    The serum PSA response was documented semimonthly until 6 weeks after the administration of 177Lu-PSMA-EB-01. PSA response was classified as the following: partial response (PR) if PSA decrease ≥50%, progressive disease (PD) if PSA increase ≥ 25% and stable disease (SD) if PSA increase <25% or PSA decrease <50%.

Study contacts

Contact information is provided by the study sponsor or research team.

Guochang Wang, MD

CONTACT

[email protected]

86-18516822732

Zhaohui Zhu, MD

CONTACT

[email protected]

86-13611093752

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Safety and Dosimetry of 177Lu-PSMA-EB-01 in Patients With Metastatic Castration-resistant Prostate Cancer

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2022
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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