Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
• Overall Status: Completed
• CT.gov ID: NCT02523924
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Actual Duration (Months): 45
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

This pilot study aims to investigate the diagnostic utility of 18F-DCFPyL, a novel low-molecular weight PSMA PET/CT imaging agent, in men with an elevated PSA following radical prostatectomy.

Condition or Disease	Intervention/Treatment	Phase
Adenocarcinoma of the Prostate	Drug: 18F-DCFPyL	N/A

Detailed Description

18F-DCFPyL is a novel low-molecular weight PSMA imaging agent. A recent study of patients with metastatic prostate cancer found that PSMA PET/CT identified more sites of disease than conventional imaging with CT, MRI and bone scan. In this study we aim to investigate 18F-DCFPyL PET/CT in patients with an elevated PSA following radical prostatectomy. During the course of this study, patients will undergo two 18F-DCPyL PET/CT scans. The first scan will take place within 45 days of staging imaging and the second will take place following six months of standard of care therapy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy
• Actual Study Start Date: Jun 2, 2015
• Actual Primary Completion Date: Nov 4, 2016
• Actual Study Completion Date: Mar 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 18F-DCFPyL PET/CT Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT	Drug: 18F-DCFPyL; 18F-DCFPyL PET/CT

Outcome Measures

Primary Outcome Measures

1. Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT [6 months]

   Number of sites with 18F-DCFPyL uptake consistent with prostate cancer.

2. Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT [6 months]

   Location of uptake of 18F-DCFPyL consistent with prostate cancer.

Secondary Outcome Measures

1. Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels [6 months]

   Number of participants with PSA 0.2-1.0ng/mL OR PSA >1.0ng/mL with at least 1 site of uptake of 18F-DCFPyL consistent with prostate cancer.

2. Correlation of Findings on 18FDCFPyL PET/CT With Those Found on Conventional Imaging (Bone Scan and Cross-sectional Imaging) [6 months]

   Number of sites with uptake on 18F-DCFPyL PET/CT and corresponding lesions identified on conventional imaging.

3. Correlation of Findings on 18F-DCFPyL PET/CT With Tissue Histology and PSMA Expression of Biopsied/Resected Pathology Specimens [6 months]

   Number of sites with 18F-DCFPyL uptake from which biopsy specimens show PSMA expression.

Other Outcome Measures

1. Correlation of 18F-DCFPyL PET/CT Findings With Time to Disease Progression [6 months]

2. Assessment of Treatment Response by 18F-DCFPyL PET/CT [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥18 years

• History of adenocarcinoma of the prostate treated with radical prostatectomy

• Serum PSA level ≥0.2 ng/mL at least 45 days prior to study enrollment

• Completed staging evaluation with bone scan as well as CT or MRI of the abdomen and pelvis at least 45 days prior to study enrollment

Exclusion Criteria:

• Intention to enroll in a blinded therapeutic clinical trial

• History of other malignancy diagnosed within the last three years (the exception of squamous cell or basal cell carcinoma of the skin)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SKCCC	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 21, 2017

More Information

Publications

None provided.

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT02523924
• Other Study ID Numbers: J1545; IRB00062296
• First Posted: Aug 14, 2015
• Last Update Posted: Jan 31, 2020
• Last Verified: Jan 1, 2020

• Additional relevant MeSH terms: Adenocarcinoma

Study Results

Participant Flow

Pre-assignment Detail	19 patients did not meet inclusion criteria.

Arm/Group Title	18F-DCFPyL PET/CT
Arm/Group Description	Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT 18F-DCFPyL: 18F-DCFPyL PET/CT
Period Title: Overall Study
STARTED	31
COMPLETED	31
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	18F-DCFPyL PET/CT
Arm/Group Description	Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT 18F-DCFPyL: 18F-DCFPyL PET/CT
Overall Participants	31
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	63
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	31 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	27 87.1%
More than one race	0 0%
Unknown or Not Reported	4 12.9%
Region of Enrollment (Count of Participants)
United States	31 100%
Months since radical prostatectomy (months) [Median (Full Range) ]
Median (Full Range) [months]	30
Gleason grade group (Count of Participants)
1	2 6.5%
2	6 19.4%
3	13 41.9%
4	1 3.2%
5	9 29%
Pathologic stage (Count of Participants)
pT2	11 35.5%
pT3a	14 45.2%
pT3b	6 19.4%
Positive surgical margin (Count of Participants)
Count of Participants [Participants]	13 41.9%
Prostate Specific Antigen (PSA) (ng/mL) [Median (Full Range) ]
Median (Full Range) [ng/mL]	0.4

Outcome Measures

1. Primary Outcome

Title	Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
Description	Number of sites with 18F-DCFPyL uptake consistent with prostate cancer.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	18F-DCFPyL PET/CT
Arm/Group Description	Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT 18F-DCFPyL: 18F-DCFPyL PET/CT
Measure Participants	31
at least 1 site	21 67.7%
> 1 site	5 16.1%
no sites	5 16.1%

2. Primary Outcome

Title	Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
Description	Location of uptake of 18F-DCFPyL consistent with prostate cancer.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Location of 18F-DCFPyL uptake could only be assessed in patients with at least 1 site of 18F-DCFPyL uptake (26/31)

Arm/Group Title	18F-DCFPyL PET/CT
Arm/Group Description	Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT 18F-DCFPyL: 18F-DCFPyL PET/CT
Measure Participants	26
Prostate bed	8 25.8%
Pelvic lymph node	14 45.2%
Nonpelvic lymph node	2 6.5%
Bone	2 6.5%
Viscera	0 0%

3. Secondary Outcome

Title	Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels
Description	Number of participants with PSA 0.2-1.0ng/mL OR PSA >1.0ng/mL with at least 1 site of uptake of 18F-DCFPyL consistent with prostate cancer.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Only 22/31 participants had a PSA of 0.2-1.0ng/mL and 9/31 participants had PSA >1.0ng/mL.

Arm/Group Title	18F-DCFPyL PET/CT
Arm/Group Description	Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT 18F-DCFPyL: 18F-DCFPyL PET/CT
Measure Participants	31
PSA 0.2-1.0 ng/mL	13 41.9%
PSA >1.0 ng/mL	8 25.8%

4. Secondary Outcome

Title	Correlation of Findings on 18FDCFPyL PET/CT With Those Found on Conventional Imaging (Bone Scan and Cross-sectional Imaging)
Description	Number of sites with uptake on 18F-DCFPyL PET/CT and corresponding lesions identified on conventional imaging.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Data was not collected for this outcome as participants did not have conventional imaging correlates.

Arm/Group Title	18F-DCFPyL PET/CT
Arm/Group Description	Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT 18F-DCFPyL: 18F-DCFPyL PET/CT
Measure Participants	0

5. Secondary Outcome

Title	Correlation of Findings on 18F-DCFPyL PET/CT With Tissue Histology and PSMA Expression of Biopsied/Resected Pathology Specimens
Description	Number of sites with 18F-DCFPyL uptake from which biopsy specimens show PSMA expression.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Data was not collected to assess this outcome measure as confirmatory biopsy was not practical to perform and histopathologic confirmation is not available.

Arm/Group Title	18F-DCFPyL PET/CT
Arm/Group Description	Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT 18F-DCFPyL: 18F-DCFPyL PET/CT
Measure Participants	0

6. Other Pre-specified Outcome

Title	Correlation of 18F-DCFPyL PET/CT Findings With Time to Disease Progression
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Other Pre-specified Outcome

Title	Assessment of Treatment Response by 18F-DCFPyL PET/CT
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	6 months
Arm/Group Title	18F-DCFPyL PET/CT
Arm/Group Description	Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT 18F-DCFPyL: 18F-DCFPyL PET/CT
All Cause Mortality
	18F-DCFPyL PET/CT
	Affected / at Risk (%)	# Events
Total	0/31 (0%)
Serious Adverse Events
	18F-DCFPyL PET/CT
	Affected / at Risk (%)	# Events
Total	0/31 (0%)
Other (Not Including Serious) Adverse Events
	18F-DCFPyL PET/CT
	Affected / at Risk (%)	# Events
Total	0/31 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.