Last updated on February 2020

Prostate Specific Membrane Antigen (PSMA)-Based PET Imaging of High Risk Prostate Cancer


Brief description of study

Background

People with prostate cancer usually have their cancer imaged with a CT scan and bone scan. They then have their prostate gland removed. Researchers want to test a scan that might predict if prostate cancer will return after this surgery.

Objective

To test if a PET/CT scan before the prostate gland is removed can predict if prostate cancer will return. Also, to test if this approach is better or worse than the usual approach for prostate cancer.

Eligibility

Men ages 18 and older with prostate cancer that appears to be contained within the prostate but is at risk of having spread

Design

Participants will be screened with:

  • Medical history
  • Blood tests
  • CT and MRI scans: Participants will lie in a machine. The machine will take pictures of the body.
  • Bone scan

Participants will have a radiotracer injected into a vein. They will have a PET/CT scan of their whole body 60 90 minutes later. During the scan, they will lie on their back and stay still.

Within 60 days after the scan, participants will have surgery. This will remove the prostate gland and lymph nodes around it. Some tissue will be used for genetic testing.

If the PET/CT scan suggests the cancer has spread, participants may need to have another biopsy within 60 days after the scan.

After surgery, participants will have follow-up visits for 5 years. They will have 5 visits the first year and 2 the second. Then they will have visits once a year.

If participants cancer returns, they will have repeat PET/CT scans.

Detailed Study Description

Background
  • About 30,000 men will die from prostate cancer in the US in 2018. The majority of these men originally presented with localized cancer.
  • Treatment options for patients with high risk, localized disease typically involve radical prostatectomy (RP) or radiation therapy (RT) in combination with androgen deprivation therapy (ADT). Following RP, 70% of patients with high-risk disease will experience a biochemical recurrence at 5 years, and approximately 20% will die of their disease in 10-15 years, likely due to metastatic disease that was not detectable using conventional imaging (99mTc-methylene diphosphonate bone scan and X-ray computed tomography) at

the time of prostatectomy.

  • Prostate-specific membrane antigen (PSMA) is commonly expressed in prostate cancers and is associated with biologic aggressiveness.
  • The second generation, PET tracer 18F-DCFPyl binds to the enzymatic portion of PSMA. It exhibits high uptake in tumor and rapid washout in normal tissues leading to high tumor to background ratios and the possibility of detecting metastases when conventional imaging is negative.
    Objective

-To determine if patients with a preoperative 18F-DCFPyL PET/CT that is negative for metastases experience 5 year progression free survival (PFS) which is improved (40%) over that of historical data (30%) based on a general population of similar patients who have not undergone imaging with 18F-DCFPyL PET/CT

Eligibility
  • Men greater than or equal to 18 years of age at the time of providing informed consent.
  • Patients must have histologically proven prostate adenocarcinoma confirmed by a CLIA certified laboratory
  • Eastern Cooperative Oncology Group (ECOG) performance status: less than or equal to 2.
  • Must have prostate cancer with high risk features defined as:
  • Gleason 8 and higher OR
  • PSA > 20 ng/mL OR
  • Clinical stage T3a (i.e. likely extraprostatic extension on MRI) or T3b
  • Laboratory parameters:
  • Hemoglobin >= 9 g/dL
  • Leukocytes >=3,000/mcL
  • Platelets >=100,000/mcL
  • Total bilirubin <2 X normal institutional limits
  • AST(SGOT)/ALT(SGPT) less than or equal to 3 X normal institutional limits
  • Creatinine <2 X normal institutional limits OR
  • eGFR >=50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (calculated via the MDRD equation)
  • Patients must be planning to undergo radical prostatectomy and lymphadenectomy regardless of findings on 18F-DCFPyL PET/CT.
  • Willingness and ability to undergo multiparametric prostate MRI and 18F-DCFPyL PET/CT
Design
  • This is an open-label, non-randomized, multi-center trial designed to evaluate the impact of 18F-DCFPyL PET/CT imaging on Progression-Free Survival at 5 years in patients with high risk localized prostate cancer.
  • All subjects meeting eligibility criteria will undergo baseline assessments to include multiparametric MRI of the prostate, 99mTc-methylene diphosphonate bone scan and contrast-enhanced CT of the abdomen and pelvis.
  • All subjects meeting eligibility criteria will undergo 18F-DCFPyL PET/CT.
  • The study will enroll up to 200 patients from 7 centers. Up to 40 patients will be enrolled at NCI.
  • All subjects will undergo radical prostatectomy and lymphadenectomy within 60 days following PET/CT imaging.
  • Subjects will be evaluated at 6 weeks, at 3, 6, 9, 12, and 18 months, at 2, 3, 4, and 5 years post-prostatectomy to determine if there has been progression and to record details of subsequent treatment and response.
  • 18F-DCFPyL PET/CT imaging will be repeated at the time of progression.

Clinical Study Identifier: NCT03976843

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