NCT04996602

Brief Summary

In recent years, quite a few studies have demonstrated the possibility of 177Lu-PSMA-617 therapy as a viable treatment option in metastatic castration resistant prostate cancer (mCRPC), which has been shown desired effect. To increase tumor accumulation and retention for radioligand therapy, and reduce dosage of 177Lu, we conjugated a truncated Evans blue (EB) molecule and DOTA chelator onto PSMA-617 (EB-PSMA) and labeled it with 177Lu. This study is designed to assess the efficiency and response to 177Lu-EB-PSMA (55 mCi) in patients with mCRPC.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P75+ for early_phase_1 prostate-cancer

Timeline
Completed

Started Jan 2019

Typical duration for early_phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2019

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

3.6 years

First QC Date

July 22, 2021

Last Update Submit

July 13, 2022

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • Therapeutic effect: PSA Response

    The serum PSA response was documented monthly until 8 weeks after the last treatment therapy, which can effectively reflect the treatment effect of prostate cancer. Biochemical 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%.

    through study completion, an average of 1 month

  • Therapeutic effect: 68Ga-PSMA PET/CT Response

    68Ga-PSMA-617 wholebody PET/CT acquisitions 8 weeks after each cycle of treatment. The molecular response was classified according to adapted modified PERSIST 1.0 criteria. Complete response (CR) was complete resolution of 68Ga-PSMA-617 uptake in the target lesions. Partial response (PR) was defined as ≥30% decrease in the SUVmax of the target lesions and total Lesions PSMA from the baseline scan, and ≥ 30% increase in the SUVmax value of the target lesions and total Lesions PSMA from the baseline scan was taken as progressive disease (PD). Neither CR, PR nor PD was considered stable disease (SD) that was \<30% decrease or \<30% increase of the target lesion. Changes of SUV (ΔSUV) between pre- and post-therapeutic PET were calculated.

    through study completion, an average of 2 months

Secondary Outcomes (1)

  • Adverse events collection: Blood tests

    through study completion, an average of 1 month

Study Arms (1)

2.0 GBq of 177Lu-EB-PSMA

EXPERIMENTAL

The patients were intravenously injected with the dose about 2.0 GBq (55 mCi) of 177Lu-EB-PSMA and underwent 68Ga-PSMA PET/CT scans before and after the treatment.

Drug: 2.0 GBq of 177Lu-EB-PSMA

Interventions

2.0 GBq of 177Lu-EB-PSMADRUG

Patients were intravenous administrated with the dose about 2.0 GBq (55 mCi) of 177Lu-EB-PSMA every 8 weeks (±1 week) for a maximum of 3 cycles.

2.0 GBq of 177Lu-EB-PSMA

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All the patients had progressive metastatic castration-resistant prostate cancer that did not respond to androgen-suppression therapy and/or systemic chemotherapy;
  • Distant metastases with high PSMA expression were confirmed on 68Ga-PSMA PET/CT within one week before the injection of 177Lu-EB-PSMA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Zhaohui Zhu, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaohui Zhu, MD

CONTACT

86-1361109375213611093752@163.com

Guochang Wang, MD

CONTACT

86-18516822732guochang1007@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2021

First Posted

August 9, 2021

Study Start

January 14, 2019

Primary Completion

September 1, 2022

Study Completion

December 1, 2022

Last Updated

July 15, 2022

Record last verified: 2022-07

Locations

CN(1)