The Role of Ga68-PSMA-11 PET Imaging in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy

NCT03977610 | Completed

• 1 other identifier: 201801384A0
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label single arm clinical trial, Plan to enroll approximately a total of 43 evaluable subjects. According to the estimated missing rate 15%, the sample size in this study is 51. Inclusion criteria: To be eligible for inclusion, each patient must fulfill all of the following criteria:

1. 1.Males with 40-85 years of age and life expectancy more than 3 months
2. 2.Pathology-proved prostate cancer patients and classified as clinical stage III or IV (including lymph node or bone metastasis)
3. 3.Willing to sign the informed consent
4. 4.Unable to tolerate the PET/CT scan, such as those with claustrophobia, unable to lie still, consciousness unclear, vital sign unstable.
5. 5.With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast.
6. 6.Significant abnormal lab data (AST or ALT more than three times of normal value), and high risk to conduct examination after evaluations of PI.
7. 7.Patient had previous malignancy history
8. 8.Patient had known allergy history or is probably allergy to Ga68-PSMA-11

Conditions

Metastatic Prostate Cancer

Keywords

Prostate cancer; Androgen deprivation therapy; Ga-68 PSMA Ligand; Treatment response

Outcome Measures

Primary Outcomes (1)

• Change of lesion detection number by PET imaging

  Lesion detection number before and under androgen deprivation therapy on the PSMA PET imaging with a time interval 10-14 weeks

  10-14 weeks

Study Arms (1)

Ga68-PSMA ligand

EXPERIMENTAL

Glass vial with 4\~20 mCi(148-740 MBq) of 68Ga-PSMA ligand in ≤10% EtOH with aqueous sterile water for injection solution (approximately 15.5 mL), more than 0.33 mCi/mL @ EOS; One time dose of 2-5 mCi (74-185 MBq) for PET Imaging ; i.v. injection

Drug: Ga-68 PSMA ligand

Interventions

Ga-68 PSMA ligand DRUG

For PSMA PET/CT scan, the subject will have catheter(s) placed for intravenous administration of \[68Ga\]PSMA-11. Subjects will receive a single intravenous bolus of 2-5 mCi \[68Ga\]PSMA-11 and received PET/CT scan 60 minutes later. Patient will underwent two times of PSMA-11 PET/CT scans before and under androgen deprivation therapy within a 10-14 weeks interval.

Also known as: Ga68-PSMA-11 (Gallium-68 labeled HBED-CC PSMA)

Ga68-PSMA ligand

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males with 40-85 years of age and life expectancy more than 3 months
• Pathology-proved prostate cancer patients and classified as clinical stage III or IV (including lymph node or bone metastasis)
• Willing to sign the informed consent

You may not qualify if:

• Unable to tolerate the PET/CT scan, such as those with claustrophobia, unable to lie still, consciousness unclear, vital sign unstable.
• With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast.
• Significant abnormal lab data (AST or ALT more than three times of normal value), and high risk to conduct examination after evaluations of PI.
• Patient had previous malignancy history
• Patient had known allergy history or is probably allergy to Ga68-PSMA-11

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital ,Linkou

Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jing-Ren Tseng, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nuclear Medicine

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 6, 2019
• Study Start: June 1, 2019
• Primary Completion: July 27, 2021
• Study Completion: July 27, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

TW (1)