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Trial record 68 of 106 for:    "Kennedy disease"

Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03800784
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
This study evaluates the rate of radiological disease progression with the new 2nd generation positron emission tomography (PET) radiopharmaceutical, 18F-DCFPyL, in patients with metastatic castration (mCRPC) and non-metastatic (nmCRPC) castration resistant prostate cancer who have evidence of biochemical (PSA) disease progression without evidence of radiological disease progression on conventional standard radiologic testing (99mTc-methylene diphosphonate bone scan and CT).

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 18F-DCFPyL Injection Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of 18F-DCFPyL PET/CT, for Detection of Radiological Progression in Patients With Metastatic (M+) and Non-metastatic (M0) Castration Resistant Prostate Cancer Receiving Standard Androgen Receptor Targeted Treatment
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 18F-DCFPyL Injection
A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
Drug: 18F-DCFPyL Injection
A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
Other Name: PyL




Primary Outcome Measures :
  1. Sensitivity 18F-DCFPyL PET/CT imaging to detect metastatic prostate cancer [ Time Frame: 3 years ]
    Proportion of patients demonstrating disease progression by conventional criteria evaluated by CT scan and 99mTc-methylene diphosphonate bone scan and on 18F-DCFPyL PET/CT.


Secondary Outcome Measures :
  1. Correlation of findings on 18F-DCFPyL PET/CT with conventional imaging as determined by Number of Lesions detected on each imaging modality [ Time Frame: 3 years ]
    Number of lesions detected on 18F-DCFPyL PET/CT in comparison to number of lesions detected on conventional imaging (99mTc-methylene diphosphonate bone scan and CT)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological confirmation of prostate cancer
  • Patients receiving androgen deprivation treatment (ADT) with GnRH analogs, GnRH antagonists or bilateral orchiectomy of any duration.
  • Cohort A: nmCRPC (status post- primary treatment with radical prostatectomy, radiation of any type or both)

    • Negative 99mTc-methylene diphosphonate bone scan and CT of the chest abdomen and pelvis within 6 weeks of 18F-DCFPyL PET/CT
    • Treatment with ADT with or without a second line novel AR targeted treatment (abiraterone, enzalutamide, or both) or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted) for ≥ 12 months.
    • Rising PSA ≥ 10 ng/ml (confirmed by 2 determinations one week apart)
    • PSADT ≤ 9 months
  • Cohort B: mCRPC

    • Treatment with ADT with or without abiraterone and or enzalutamide or both for ≥ 6 months and/or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted).
    • PSA ≥ 2.0 ng/ml confirmed X 1 week apart, any PSADT
  • Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility.
  • No new therapeutic interventions planned or scheduled to be instituted prior to the course of this study both on cohorts A and B before conventional radiologic progression is evidenced.
  • Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.

Exclusion Criteria:

  • Patient will be excluded from enrollment if he had a radioisotope within 5 physical half-lives prior to PET imaging

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): NCT03800784


Contacts
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Contact: Rehab AbdAllah, MB BCh 410-955-4042 rabdall1@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Rehab AbdAllah, MB BCh    410-955-4042    rabdall1@jhmi.edu   
Principal Investigator: Mark Markowski, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
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Principal Investigator: Mark Markowski Johns Hopkins University

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03800784     History of Changes
Other Study ID Numbers: J1863
IRB00150136 ( Other Identifier: JHM IRB )
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
18F-DCFPyL PET/CT PyL
PSMA
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases