Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer (CONDOR)

Progenics Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Prostate Adenocarcinoma; Prostate Cancer Recurrent; Prostate Cancer Metastatic; Prostate Cancer

Treatments: Diagnostic Test: PET/CT Imaging; Drug: 18F-DCFPyL

Study type: Interventional

Funder types: Industry

Identifiers

NCT03739684

PyL 3301

Details and patient eligibility

About

This study evaluates the diagnostic performance and safety of 18F-DCFPyL (PyL) PET/CT imaging in patients with suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.

Enrollment: 208 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male >/= 18 years of age

• Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy

• Suspected recurrence of prostate cancer based on rising PSA after definitive therapy on the basis of:

  1. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (American Urological Association [AUA]); or
  2. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (American Society for Therapeutic Radiology and Oncology [ASTRO]-Phoenix)

• Negative or equivocal findings for prostate cancer on conventional imaging performed as part of standard of care workup within 60 days prior to Day 1

• Life expectancy ≥6 months as determined by the investigator

• Able and willing to provide informed consent and comply with protocol requirements

Exclusion criteria

• Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within five (5) physical half-lives prior to Day 1
• Ongoing treatment with any systemic therapy (e.g. ADT, antiandrogen, GnRH, LHRH agonist or antagonist) for prostate cancer
• Treatment with ADT in the past 3 months of Day 1
• Receipt of investigational therapy for prostate cancer within 60 days of Day 1
• Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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208 participants in 1 patient group

18F-DCFPyL Injection

Experimental group

Description:

9 mCi (333 MBq) IV injection of 18F-DCFPyL

Treatment:

Diagnostic Test: PET/CT Imaging

Drug: 18F-DCFPyL