Clinical trial NCT02420977: Evaluation of PSMA-based PET as an Imaging Biomarker in Prostate Cancer
Official title: Evaluation of PSMA-based PET as an Imaging Biomarker of Androgen Receptor Signaling in High-Risk Localized and Locally Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Advanced Prostate Cancer
Keywords: radiotracer
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-04-20
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This research is being done to see if an investigational radioactive imaging agent (radiotracer) called 18F-DCFPyL can help us find prostate cancer at its original site in the prostate gland and in distant sites (bone, lymph nodes) in men diagnosed with prostate cancer before surgery.

Detailed description: The investigators propose to evaluate the feasibility of using a novel small molecule PET radiotracer, DCFPyL to target prostate cancer prostate-specific membrane antigen (PSMA). PSMA is a well studied cell surface marker of prostate cancer with increased expression associated with higher tumor grade and advanced metastatic tumors. More specifically it is associated with a higher Gleason score and there is evidence it can serve as a potential marker for prostate tumor carcinogenesis, progression and as a AR signaling surrogate marker of ADT response. This small molecule PET radiotracer specifically targeting an important prostate specific marker of AR signaling dynamics following ADT, tumor progression and metastatic potential warrants validation as an in-vivo non-invasive imaging biomarker for PSMA expression and prostate cancer detection.

Eligibility criteria: Inclusion Criteria:

* Men 18 years of age or greater with recently diagnosed prostate cancer with planned radiation and ADT.
* Key inclusion criteria (the entire list of inclusion and exclusion criteria will appear later in section 4 of the protocol)

  * Newly diagnosed prostate cancer pathologically proven by prostate biopsy
  * Prostate biopsy histology grade ≥ Gleason 8-10
  * Patients considered as candidates for and medically fit to undergo radiation and ADT
  * At least 10 days after most recent prostate biopsy

Exclusion Criteria:

* Prior pelvic external beam radiation therapy or brachytherapy
* Chemotherapy for prostate cancer
* Hormone deprivation therapy
* Investigational therapy for prostate cancer
* Hemorrhagic cystitis or active prostatitis

Primary outcomes:
measure: Response rate differences
timeFrame: baseline and after 2-3 months
Secondary outcomes:
measure: Biomarker changes
timeFrame: Baseline and at 2=3 months
measure: Metabolic tumor uptake changes
timeFrame: baseline and then at 2-3 months
measure: Gene expression changes
timeFrame: Baseline and then at 2-3 months
measure: Nodal metastatic disease changes
timeFrame: Baseline and then at 2-3 months
measure: All cause DCFPyL PET-MRI fusion or PET/MRI toxicity
timeFrame: Baseline and then at 2-3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Curtiland Deville
state: Maryland
Study officials:
affiliation: The SKCCC at Johns Hopkins
name: Curtiland Deville, M.D.
role: PRINCIPAL_INVESTIGATOR
References: