Clinical trial NCT03800784: Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Keywords: 18F-DCFPyL PET/CT PyL
PSMA
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


Eligibility 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

Primary outcomes:
measure: Sensitivity 18F-DCFPyL PET/CT imaging to detect metastatic prostate cancer
timeFrame: 3 years
Secondary outcomes:
measure: Correlation of findings on 18F-DCFPyL PET/CT with conventional imaging as determined by Number of Lesions detected on each imaging modality
timeFrame: 3 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mark Markowski
role: PRINCIPAL_INVESTIGATOR
References: