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

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ClinicalTrials.gov Identifier: NCT03976843
Recruitment Status : Not yet recruiting
First Posted : June 6, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date August 16, 2019
Estimated Study Start Date  ICMJE August 21, 2019
Estimated Primary Completion Date August 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
progression free survival [ Time Frame: 6 weeks, 3,6,9,12, and 18 months, 2,3, and 4 years ]
progression-free survival which is improved over that of historical data from a general population
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03976843 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prostate Specific Membrane Antigen (PSMA)-Based PET Imaging of High Risk Prostate Cancer
Official Title  ICMJE A Phase II Multi-Institutional Trial to Evaluate Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer
Brief Summary

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 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:

Primary 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Drug: 18F-DCFPyL
18F-labeled agent that is a high affinity small molecule inhibitor of PSMA to detect prostate cancer via PET imaging
Study Arms  ICMJE Experimental: 1/18F-DCFPyL PET/CT + radical prostatectomy
18F-DCFPyL PET/CT with radical prostatectomy andlymphadenectomy
Intervention: Drug: 18F-DCFPyL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2025
Estimated Primary Completion Date August 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • INCLUSION CRITERIA:

2.1.1.1 Patients must have histologically proven prostate adenocarcinoma confirmed by a CLIA certified laboratory.

2.1.1.2 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

2.1.1.3 Patients must be eligible for and must be planning to undergo radical prostatectomy and lymphadenectomy regardless of findings on 18F-DCFPyL PET/CT

2.1.1.4 Men age >18 years.

2.1.1.5 ECOG performance status <2

2.1.1.6 Patients must have adequate organ and marrow function as defined below:

  • Hemoglobin greater than or equal to 9 g/dL
  • leukocytes greater than or equal to 3,000/mcL
  • platelets greater than or equal to 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 greater than or equal to 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

2.1.1.7 Ability of subject to understand and the willingness to sign a written informed consent document.

2.1.1.8 Willingness and ability to undergo biopsy of radiotracer-avid lesion if feasible.

2.1.1.9 Willingness and ability to undergo multiparametric prostate MRI and 18F-DCFPyL PET/CT

EXCLUSION CRITERIA

2.1.2.1 Any investigational agents in the past 28 days prior to enrollment.

2.1.2.2 Clinical stage T4 (tumor invades adjacent structures except seminal vesicles).

2.1.2.3 Distant metastatic disease on conventional imaging studies (computed tomography (CT) of the abdomen and pelvis and 99mTc-methylene diphosphonate bone scan (bone scan)). NaF PET/CT scan cannot substitute for a bone scan. Given lack of specificity of CT for lymph node metastases at lower thresholds (34, 35), pelvic lymph nodes below 2 cm in the short axis are allowed.

2.1.2.4 Any prior hormone therapy used to treat prostate cancer, except limited androgen receptor antagonist therapy, defined as less than or equal to 3 days of treatment. The medication must be discontinued within 5 half-lives of the compound prior to study entry.

2.1.2.5 Any prior therapy for prostate cancer with surgery, radiation, and/or chemotherapy.

2.1.2.6 Contraindication to MRI or PET:

  • Patients weighing more than weight limit for the scanner tables or unable to fit within the imaging gantry
  • Prior reaction to 18F-DCFPyL
  • Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic device that are not MRI compatible at 3 T
  • Severe claustrophobia unresponsive to oral anxiolytics

2.1.2.7 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

2.1.2.8 Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for the protocol procedures or for radical prostatectomy.

2.1.2.9 A malignancy within the past 3 years for which prostatectomy is a contraindication.

2.1.2.10 Radiotracer administered within 5 half-lives prior to the date of 18F-DCFPyL PET/CT imaging.

2.1.2.11 PSMA-targeted imaging within 6 months prior to the date of 18F-DCFPyL PET/CT imaging.

2.1.2.12 Unable to refrain from fathering a child or donating sperm for 10 days after each 18FDCFPyL injection.

2.1.3 Recruitment Strategies

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Guinevere Chun, R.N. (240) 760-7967 gchun@mail.nih.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03976843
Other Study ID Numbers  ICMJE 190104
19-C-0104
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William L Dahut, M.D. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date May 28, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP