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18F-DCFPyL PET/CT in Men With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03824275
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Emerson Lim, Columbia University

Brief Summary:
PyL, also known as [18F]DCFPyL, is a second-generation fluorinated PSMA targeted PET imaging agent.14 In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging.15 Its ability to image metastatic protate cancer sites was comparable to 68Ga-PSMA with high tumor-to-background ratios.16 Additionally, [18F] PyL demonstrated higher mean tumor-to-background ratios when using kidney, spleen, or parotid as reference organs. However, the role of [18F] PyL in tumor response to therapy has not been evaluated, specifically the potential to serve as a predictive biomarker of response. Given the high cost of current therapeutic agents in mCRPC, there is a need for an early response biomarker to stratify which patients will benefit from therapy and which will not. This will also allow for earlier change in management of patients who will not response to these therapies, potentially improving patient outcomes.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: 18F- DCFPyL PET/CT Phase 2 Phase 3

Detailed Description:

The investigators will conduct a prospective phase II/III study of 300 men diagnosed with prostate cancer with a rising PSA.

Upon enrollment, subjects will undergo standard of care imaging (defined as a CT or MRI of the chest, abdomen, and pelvis, and 99mTc bone scans) if not obtained within 45 days of enrollment. Subjects will have standard of care laboratory evaluations including CBC, serum chemistries, hepatic panel, LDH, and PSA. Liquid biopsies for ctDNA and exosome analysis will occur at the same time. Subjects will then undergo18F- DCFPyL PET/CT.

If part of the subject's standard of care treatment plan (as determined by the subject's treating provider), lesions identified on 18F- DCFPyL PET/CT will be validated histologically. Otherwise 18F- DCFPyL PET/CT identified oligometastatic lesions will be validated by RECIST measurements or PSA changes during standard of care follow up imaging and/or serum PSA analysis after focal targeted therapies as deemed clinically appropriate by the subject's treating provider.

[18F]DCFPyL will be used for study imaging. It will be produced using methods previously published.14,15 In initial trials, the effective dose from [18F]DCFPyL was 0.0165 mSv/MBq or 6.1 mGy (0.61 rem) for an injected dose of 370 MBq (10 mCi). The highest radiation dose was estimated for the kidneys (0.0945 mGy/MBq), followed by urinary bladder wall (0.0864 mGy/MBq), submandibular glands (0.0387 mGy/MBq), and liver (0.0380 mGy/MBq). The mean absorbed dose to the bone marrow was 0.01 mGy/ MBq.

In comparison to the published data on [18F]DCFBC,39 [18F]DCFPyL shows significantly lower doses in most radiosensitive organs such as the thymus, osteogenic cells, red marrow, breast, testes, uterus and ovaries. Less radiation dose was also measured in the stomach wall, small intestine, large intestinal wall, lungs, heart wall, brain, skin, muscle, thyroid and gallbladder wall. Radiation dose from [18F]DCFPyL was higher in the kidneys, adrenals, urinary bladder wall, liver, pancreas and spleen.

Toxicities experienced with this agent were minimal and included three grade 1 adverse events including a mild headache and mild nosebleed both of which were felt to be unrelated to the radiotracer and resolved without treatment. Another subject experienced a decrease in platelet count on routine assessment during the post-imaging follow up, but was attributed to the patient starting treatment for prostate cancer.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, non-randomized
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-DCFPyL PET/CT in Men With Prostate Cancer
Estimated Study Start Date : February 15, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 18F- DCFPyL PET/CT
Upon enrollment, subjects will undergo standard of care imaging (defined as a CT or MRI of the chest, abdomen, and pelvis, and 99mTc bone scans) if not obtained within 45 days of enrollment. Subjects will have standard of care laboratory evaluations including CBC, serum chemistries, hepatic panel, LDH, and PSA. Liquid biopsies for ctDNA and exosome analysis will occur at the same time. Subjects will then undergo18F- DCFPyL PET/CT.
Drug: 18F- DCFPyL PET/CT
A CT scan using a radioactive marker to better image tumors
Other Name: CT scan




Primary Outcome Measures :
  1. To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis [ Time Frame: 3.5 years ]
    To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis


Secondary Outcome Measures :
  1. To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-region basis, with regions being the prostate or prostate bed, pelvis, extra pelvis, and bones [ Time Frame: 3.5 years ]
    To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-region basis

  2. To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis [ Time Frame: 3.5 years ]
    To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis


Other Outcome Measures:
  1. To characterize ctDNA and exosomes in patients with prostate cancer [ Time Frame: 3.5 years ]
    To characterize ctDNA and exosomes in patients with prostate cancer

  2. To determine correlation with ctDNA and/or exosome levels with disease burden [ Time Frame: 3.5 years ]
    To determine correlation with ctDNA and/or exosome levels with disease burden



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed diagnosis of prostate cancer
  2. PSA ≥ 0.2ng/ml
  3. Age ≥ 18 years of age
  4. ECOG performance status ≤ 2 (Karnosfky ≥ 60%, see Appendix A)
  5. Ability to understand and willingness to sign a written informed consent document
  6. Wiling to comply with clinical trial instructions and requirements
  7. Able to cover the cost of PyL PET/CT imaging

Exclusion Criteria:

  1. History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin
  2. Presence of prostate brachytherapy implants
  3. Administration of another radioisotope within five physical half-lives of trial enrollment
  4. Radiation or chemotherapy within 2 weeks prior to trial enrollment
  5. Serum creatinine > 3 times the upper limit of normal
  6. Serum total bilirubin > 3 times the upper limit of normal
  7. AST or ALT >5 times the upper limit of normal
  8. Inadequate venous access

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824275


Contacts
Contact: Ana Serra (212) 304-5558 as5713@cumc.columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University

Responsible Party: Emerson Lim, Associate Clinical Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03824275     History of Changes
Other Study ID Numbers: AAAS1862
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases