A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Dosimetry, and Anti-tumor Activity of Ga-68-NGUL / Lu-177-DGUL in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Refractory to Standard Therapy

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Description

This clinical trial is an open-label, single-arm, multi-center, escalation (Phase 1 Part B only), rater-blind (Phase 2 only), phase 1/2 trial to evaluate the diagnostic validity/safety of Ga-68-NGUL and efficacy/safety of Lu-177-DGUL on the anti-tumor activity that aims to simultaneously evaluate diagnostic and therapeutic validity.

Targeted Conditions

Study Overview

Start Date
April 12, 2021
Completion Date
December 31, 2024
Enrollment
73
Date Posted
September 21, 2022
Accepts Healthy Volunteers?
Yes
Gender
Male

Locations

Full Address
Chonnam National University Hwasun Hospital
Hwasun 03127, Korea, Republic of

Seoul National University Hospital
Seoul, Korea, Republic of

Asan Medical Center
Seoul, Korea, Republic of

Seoul National University Bundang Hospital
Seoul, Korea, Republic of

Eligibility

Minimum Age (years)
19
Eligibility Criteria
Inclusion Criteria:

Male patients of 19 years or older
Patients with metastatic diseases due to adenocarcinoma of the prostate as confirmed
Patients whose blood testosterone levels at the screening visit meet the castration criteria(< 50 ng/dL)
Patients with advanced metastatic castration-resistant prostate cancer who have failed standard treatment or no longer have standard treatment available
Those who are maintaining androgen deprivation therapy (ADT) regardless of the type
Patients receiving bone resorption treatment who have maintained a stable dose for at least 4 weeks prior to baseline
Patients with positive lesions on Ga-68-NGUL PET scan
Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Patients with an expected survival of 6months or more
Patients with confirmed adequate hematological function, renal and hepatic function according to the following criteria
Patients who have voluntarily consented to participate in this clinical trial and signed the informed consent form

Exclusion Criteria:

Patients with hematologic malignancy, including lymphoma and solid cancers other than prostate cancer, within 3 years prior to baseline
Patients who have received chemotherapy, biotherapy, or immunotherapy for prostate cancer treatment within 4 weeks prior to baseline
Patients who have received radiation chemotherapy or radiation therapy within 12 weeks prior to baseline
Patients who have received high-dose chemotherapy requiring hematopoietic stem cell therapy within 2 years prior to baseline
Those who had previously received PSMA-targeted treatment or received radiopharmaceutical treatment, such as radium-223, within 6 months prior to baseline
Patients with symptomatic central nervous system metastases
Patients with unsuitable medical history or surgical/procedural history
Patients with severe drug hypersensitivity and a history of hypersensitivity to the investigational product and similar drugs
Patients receiving concomitant nephrotoxic drugs
Patients with severe claustrophobia that is not controlled with anti-anxiety medications
Patients with hypersensitivity reactions to components of the investigational product
If the partner is a female of childbearing potential, patients who do not intend to abstain from abstinence or use appropriate contraceptive methods for at least 3 months after the end of the clinical trial period and investigational product administration
Patients who have been administered with other investigational products or treated with clinical investigational devices within 4 weeks prior to baseline
Patients who cannot participate in the clinical trial as determined by other investigators

Study Contact Info

Study Contact Name
bora Jeong; hee jeong SEO

Contact Listings Owner Form

A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Dosimetry, and Anti-tumor Activity of Ga-68-NGUL / Lu-177-DGUL in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Refractory to Standard Therapy 0 reviews

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05547061