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Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan

Primary Purpose

Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Metastatic Castration-resistant Prostate Carcinoma

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
18F-DCFPyl
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Metastatic Castration-resistant Prostate Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Participants must have histologically or cytologically confirmed prostate cancer. Age ≥18 years. Participants must be planned for standard-of-care 177Lu-Vipivotide Tetraxetan therapy after the 18F-DCFPyL PSMA-PET. -≥1 PSMA-avid lesion on 68Ga-PSMA-11 PSMA-PET performed within 120 days of study entry (to meet eligibility for 177Lu-Vipivotide Tetraxetan therapy). Ability and willingness to comply with the study procedures. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational agent are eligible for this trial. The effects of 18F-DCFPyL on the developing human fetus are unknown. For this reason and because radiopharmaceutical agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 24 hours after the 18F-DCFPyL PSMA-PET scan. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Contraindications to PET/CT, including severe claustrophobia. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-DCFPyL Any past or current condition that, in the opinion of the study investigators, would confound the results of the study or would pose additional risk or burden to the patient by their participation in the study.

Sites / Locations

  • Dana Farber Cancer Institute
  • Brigham and Womens Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-DCFPYL-PSMA PET

Arm Description

Study procedures will be conducted as follows: Baseline screening visit with PSMA-PET/CT scan with Ga-PSMA-11. In-clinic visit with exam and PSMA-PET/CT scan with 18F-DCFPyl per standard institutional procedures. Standard of care therapy. Follow up every 3 months via chart review for 12 months, with the purpose of seeing how participants respond to 177Luvipivotide tetraxetan treatment.

Outcomes

Primary Outcome Measures

Proportion of Participants with PSMA-Positive Lesion
Defined as the number of participants with at least 1 PSMA-positive lesion on 18F-DCFPyL PSMA-PET.

Secondary Outcome Measures

Full Information

First Posted
October 19, 2023
Last Updated
October 19, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Progenics Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06099093
Brief Title
Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan
Official Title
A Pilot Study of 18F-DCFPyL-PSMA PET in Patients Receiving 177Lu-Vipivotide Tetraxetan Therapy for Metastatic Castrate-resistant Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2024 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Progenics Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this research study is to see how well an imaging test, called 18FDCFPyL prostate specific membrane antigen (PSMA) positron emission tomography (PET), can show the extent of prostate cancer when comparing to 68Ga-PSMA-11 PET/CT (another type of diagnostic scan for prostate cancer).
Detailed Description
This is a one-arm single-stage prospective pilot study to determine how 18F-DCFPyL PSMA-PET/CT can be used as a diagnostic test before treatment with 177Lu-vipivotide tetraxetan, which is an approved therapy for advanced prostate cancer. The U.S. Food and Drug Administration (FDA) has approved 18F-DCFPyL as a diagnostic agent (radiotracer) option for prostate cancer, though it is not specifically approved for participants who are due to receive 177Lu-vipivotide tetraxetan therapy. This research study involves a single PET scan using the imaging agent 18F-DCFPyL and the collection of information from medical records. Participation in this research study is expected to last about 12 months. It is expected that about 30 people will take part in this research study. Progenics Pharmaceuticals, Inc. is funding this research study by providing funding and the imaging agent, 18F-DCFPyL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Metastatic Castration-resistant Prostate Carcinoma
Keywords
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Metastatic Castration-resistant Prostate Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18F-DCFPYL-PSMA PET
Arm Type
Experimental
Arm Description
Study procedures will be conducted as follows: Baseline screening visit with PSMA-PET/CT scan with Ga-PSMA-11. In-clinic visit with exam and PSMA-PET/CT scan with 18F-DCFPyl per standard institutional procedures. Standard of care therapy. Follow up every 3 months via chart review for 12 months, with the purpose of seeing how participants respond to 177Luvipivotide tetraxetan treatment.
Intervention Type
Drug
Intervention Name(s)
18F-DCFPyl
Other Intervention Name(s)
[F18]-Piflufolastat, Pylarify, 2-(3-{1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]- pentyl}ureido)-pentanedioic acid
Intervention Description
Fluorine-labeled small molecule, via intravenous infusion per protocol.
Primary Outcome Measure Information:
Title
Proportion of Participants with PSMA-Positive Lesion
Description
Defined as the number of participants with at least 1 PSMA-positive lesion on 18F-DCFPyL PSMA-PET.
Time Frame
1 Day

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must have histologically or cytologically confirmed prostate cancer. Age ≥18 years. Participants must be planned for standard-of-care 177Lu-Vipivotide Tetraxetan therapy after the 18F-DCFPyL PSMA-PET. -≥1 PSMA-avid lesion on 68Ga-PSMA-11 PSMA-PET performed within 120 days of study entry (to meet eligibility for 177Lu-Vipivotide Tetraxetan therapy). Ability and willingness to comply with the study procedures. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational agent are eligible for this trial. The effects of 18F-DCFPyL on the developing human fetus are unknown. For this reason and because radiopharmaceutical agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 24 hours after the 18F-DCFPyL PSMA-PET scan. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Contraindications to PET/CT, including severe claustrophobia. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-DCFPyL Any past or current condition that, in the opinion of the study investigators, would confound the results of the study or would pose additional risk or burden to the patient by their participation in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Jacene, MD
Phone
617-632-3767
Email
hjacene@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Jacene, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Brigham and Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan

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