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

Johns Hopkins Medicine

Status and phase

Withdrawn

Phase 3

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: 18F-DCFPyL Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT03800784

J1863

IRB00150136 (Other Identifier)

Details and patient eligibility

About

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).

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.