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Trial record 36 of 1543 for:    Androgens

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

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ClinicalTrials.gov Identifier: NCT03977610
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Tseng Jing-Ren, Chang Gung Memorial Hospital

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

Exclusion criteria:

Patient who has any of the following criteria will be excluded from the trial:

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

Condition or disease Intervention/treatment Phase
Metastatic Prostate Cancer Drug: Ga-68 PSMA ligand Not Applicable

Detailed Description:

It is a single-arm clinical trial. The primary endpoint is diagnostic positivity rate of Ga68-PSMA-11 in metastasis lesion. Sample size calculation is performed using two-sided one-proportion test to achieving an 82% power at the 5% level of significance. The primary measurement of positivity can be obtained for the one-proportion test with statistical hypotheses H0: P = P0 versus H1: P≠P0. We assume the alternative positivity rate is 65.9% and the null positivity rate is 43.9% which is the reference value from Maurer T et al (J Urol. 2016;195:1436-1443). Thus, the sample size needed is 43. According to the estimated missing rate 15%, the sample size in this study is 51. The sample size calculation was performed using PASS software (Power Analysis and Sample Size version 11.0.8, NCSS, Kaysville, Utah, USA). All subjects enrolled must meet eligibility criteria based on the inclusion/exclusion criteria detailed in Section 5.4 and 5.5.

For PET/CT PSMA 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. The data acquisition begin with non-contrast CT at 120kVp, automated mAs, and a pitch of 1.5, followed by PET acquisition from the mid-thigh to skull-base, 3 minutes each bed. After image acquisition, the subject will be observed for half an hour, and will be discharged if no adverse event happens. EKG, blood and biochemistry test will be performed before and after scan no more than two weeks. Patient will underwent two times of PSMA-11 PET/CT scans before and under androgen deprivation therapy within a 10-14 weeks interval. In the follow up period, if metastatic castration-resistance status happens, patient may underwent optional PSMA-11 PET/CT scan by attending's discrimination in order to give appropriate treatment suggestions.

Time elapsed from the last PSA determination until PET scan was no more than 6 weeks in all patients. Patients will receive complementary workups. All of the images were interpreted by a team of two nuclear medicine physicians and one radiologist. In cases of questionable findings, the decision was made by consensus of at least two observers using pre-specified criteria. For patients with discrepancy image findings between each modality, biopsy results may be taken into consideration to determine the final status.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Role of Ga68-PSMA-11 PET Imaging in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ga68-PSMA ligand
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
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.
Other Name: Ga68-PSMA-11 (Gallium-68 labeled HBED-CC PSMA)




Primary Outcome Measures :
  1. Change of lesion detection number by PET imaging [ Time Frame: 10-14 weeks ]
    Lesion detection number before and under androgen deprivation therapy on the PSMA PET imaging with a time interval 10-14 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03977610


Contacts
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Contact: Jing-Ren Tseng, MD 0975-361-314 b9105019@gmail.com

Locations
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Taiwan
Chang Gung Memorial Hospital ,Linkou Recruiting
Taoyuan City, Taiwan, 333
Contact: Jing-Ren Tseng, MD    09753-61314    b9105019@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Jing-Ren Tseng, MD Chang Gung Memorial Hospital

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Responsible Party: Tseng Jing-Ren, Nuclear Medicine, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03977610     History of Changes
Other Study ID Numbers: 201801384A0
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tseng Jing-Ren, Chang Gung Memorial Hospital:
Prostate cancer
Androgen deprivation therapy
Ga-68 PSMA Ligand
Treatment response
Additional relevant MeSH terms:
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Androgens
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs