Metastatic Prostate Cancer
Conditions
Keywords
Metastatic Prostate Cancer
Brief summary
This research is being done to see if an investigational radioactive drug called 18F-DCFBC can help us find cancer that has spread (metastatic disease) from its original site in people who have cancer in their prostate to other parts of their body.
Detailed description
The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), \[18F\]DCFBC (DCFBC) PET imaging for detection of metastatic prostate cancer. PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential. The investigators propose to assess the ability of DCFBC PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis. Correlation will be made to sites of suspected metastatic disease detected by standard conventional imaging modalities (CIM) for prostate cancer which includes IV contrast CT of chest/abdomen/pelvis and whole body bone scintigraphy.
Interventions
DRUG18F-DCFBC
18F-DCFBC is a radiofluorinated small-molecule inhibitor of prostate-specific membrane antigen (PSMA). A bolus of 10 mCi (370 MBq) \[9-11 mCi (333-407 MBq)\] of 18F-DCFBC will be injected into the IV line by slow IV push.
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Histological confirmation of prostate cancer 2. Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, \[18F\]Sodium Fluoride PET, and/or \[18F\]FDG PET 3. Rising PSA on two observations taken at least 1 week apart 4. Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration 5. Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease 6. Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging 7. Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits 8. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures
Exclusion criteria
1. Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration 2. Prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest) 3. Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression. 4. Serum creatinine \> 3 times the upper limit of normal 5. Total bilirubin \> 3 times the upper limit of normal 6. Liver Transaminases \> 5times the upper limit of normal 7. Unable to lie flat during or tolerate PET/CT 8. Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM) | 24 Months | Measurement of sensitivity of DCFBC PET to CIM (contrast-enhanced CT and bone scintigraphy) for detection of metastatic prostate cancer based on number of lesions that are detected on PET/CT, in agreement with CT and CIM. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of Detection of New or Progression of Metastasis | up to 1 year | Sensitivity of DCFBC-PET and conventional imaging modalities (CIM), which include bone scintigraphy (BS) and contrast-enhanced computed tomography (CECT) to detect new or progression of metastases at follow-up, where equivocal lesions are considered negative. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive, therefore, sensitivity is a proportion of responsive lesions to the total number of lesions analyzed. |
Countries
United States
Participant flow
Pre-assignment details
22 participants enrolled, 5 screen failures, therefore only 17 participants started the study.
Participants by arm
| Arm | Count |
|---|---|
| 18F-DCFBC Participants with hormone-naive prostate cancer (HNPC) and castration-resistant prostate cancer (CRPC) with metastatic lesions detected on conventional imaging modalities (contrast-enhanced computed tomography \[CECT\] and bone scintigraphy \[BS\]) undergo PET imaging with 18F-DCFBC radiotracer. | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | 18F-DCFBC | — |
|---|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 7.89 | — |
| Prior prostate cancer therapy Abiraterone | 1 Participants | — |
| Prior prostate cancer therapy Androgen deprivation | 8 Participants | — |
| Prior prostate cancer therapy Docetaxel | 2 Participants | — |
| Prior prostate cancer therapy External-beam radiation to the pelvis | 7 Participants | — |
| Prior prostate cancer therapy External-beam radiation to the right hip | 1 Participants | — |
| Prior prostate cancer therapy External-beam radiation to the spine | 1 Participants | — |
| Prior prostate cancer therapy None | 1 Participants | — |
| Prior prostate cancer therapy Prostate brachytherapy | 1 Participants | — |
| Prior prostate cancer therapy Prostatectomy | 7 Participants | — |
| Prior prostate cancer therapy Radium-223 (223Ra) | 1 Participants | — |
| Prior prostate cancer therapy Tasquinimod | 1 Participants | — |
| Prostate specific antigen (PSA) | 95.6 ng/mL STANDARD_DEVIATION 141.26 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Red cell folate | 550.69 ng/mL | — |
| Region of Enrollment United States | 17 Participants | — |
| Serum folate 21-24 ng/mL | 1 Participants | — |
| Serum folate High (>24 ng/mL) | 5 Participants | — |
| Serum folate Normal range (2.5-20 ng/mL) | 11 Participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 17 Participants | — |
| Testosterone | 396.33 ng/mL | — |
| Testosterone <20 ng/mL | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 4 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM)
Measurement of sensitivity of DCFBC PET to CIM (contrast-enhanced CT and bone scintigraphy) for detection of metastatic prostate cancer based on number of lesions that are detected on PET/CT, in agreement with CT and CIM. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive.
Time frame: 24 Months
Population: Combined Imaging Modality (CIM) refers to both CT and BS imaging. The total number of lesions analyzed by both CT and BS (CIM) are 235 (as represented by PET-positive and PET-negative, equivocal CIM). There is overlap in the number of lesions detected by conventional imaging modalities (ie: bone scan and computed tomography)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 18F-DCFBC | Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM) | PET Positive, Combined CIM negative/equivocal | 170 lesions detected |
| 18F-DCFBC | Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM) | PET negative/equivocal, CT positive | 50 lesions detected |
| 18F-DCFBC | Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM) | PET Positive, CT negative/equivocal | 148 lesions detected |
| 18F-DCFBC | Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM) | PET Positive, BS negative/equivocal | 170 lesions detected |
| 18F-DCFBC | Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM) | PET negative/equivocal, BS positive | 14 lesions detected |
| 18F-DCFBC | Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM) | PET negative/equivocal, Combined CIM positive | 55 lesions detected |
Secondary
Sensitivity of Detection of New or Progression of Metastasis
Sensitivity of DCFBC-PET and conventional imaging modalities (CIM), which include bone scintigraphy (BS) and contrast-enhanced computed tomography (CECT) to detect new or progression of metastases at follow-up, where equivocal lesions are considered negative. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive, therefore, sensitivity is a proportion of responsive lesions to the total number of lesions analyzed.
Time frame: up to 1 year
Population: Follow-up CIM was only available for 12 of the 17 participants. 92% of the lesions detected via 18F-DCFBC PET were marked as true positive.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 18F-DCFBC | Sensitivity of Detection of New or Progression of Metastasis | 18F-DCFBC PET | 0.92 proportion of responsive lesions |
| 18F-DCFBC | Sensitivity of Detection of New or Progression of Metastasis | CECT | 0.64 proportion of responsive lesions |
| 18F-DCFBC | Sensitivity of Detection of New or Progression of Metastasis | BS | 0.40 proportion of responsive lesions |
| 18F-DCFBC | Sensitivity of Detection of New or Progression of Metastasis | Combined CIM (BS and CECT) | 0.71 proportion of responsive lesions |