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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    48
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 13 March 2021
prostatectomy
gonadotropin
androgens
antiandrogen therapy
androgen suppression
bone scan
bicalutamide
flutamide
antiandrogens
nilutamide
abiraterone
orchiectomy
enzalutamide
pet/ct scan
gonadorelin
bilateral orchidectomy
diphosphonates

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).

Details
Condition Malignant neoplasm of prostate, Prostatic disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate carcinoma, prostate cancers
Treatment 18F-DCFPyL Injection
Clinical Study IdentifierNCT03800784
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on13 March 2021

Eligibility

Yes No Not Sure

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
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