search
Back to results

PSMA-PET/MRI Low- and Intermediate-Risk Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
68Ga-HBED-CC-PSMA
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information
  • Male subjects ≥ 18 years of age
  • Histologically confirmed prostate adenocarcinoma
  • Low or favorable intermediate risk, based on the NCCN criteria
  • Subject has adequate performance status as defined by ECOG performance status of 0-2
  • Subject is willing and able to comply with the protocol as determined by the Treating Investigator
  • Subject speaks English (quality of life instrument is validated in English)

Exclusion Criteria:

  • Contraindications for MRI
  • Other prior or concomitant malignancies, with the exception of:
  • non-melanoma skin cancer
  • other cancer for which the subject has been disease free for ≥5 years before the first study treatment and of low potential risk for recurrence
  • Inflammatory bowel disease
  • Previous transurethral resection of the prostate (TURP) or surgery of the prostate

Sites / Locations

  • University of North Carolina - Chapel HillRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PMSA-PET/MRI

Arm Description

Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment

Outcomes

Primary Outcome Measures

Genitourinary and gastrointestinal toxicity 12 months post-treatment
Grade 2+ GU/GI late toxicity as classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 at 12 months after radiation therapy
Feasibility of meeting specified dose constraints
Proportion of subjects who meet these criteria: Boost dose coverage: DIL D95% ≥ 44 Gy Dose constraints: Urethra Dmax < 40 Gy Bladder Dmax < 45.6 Gy Bladder D10cc < 41.8 Gy Rectum Dmax < 38 Gy Rectal Mucosa D1% < 28.5 Gy Sigmoid Colon Dmax < 28.5 Gy

Secondary Outcome Measures

Acute and late genitourinary and gastrointestinal toxicity
GU and GI toxicity as classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Will be measured during radiation therapy and at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after radiotherapy.
Biochemical control using Prostate-Specific Antigen (PSA) levels
Biochemical control will be defined according to the Phoenix criteria at 2 and 5 years after radiation therapy
Patient-reported quality of life using the Expanded Prostate Cancer Index Composite (EPIC-26)
Measuring patient-reported quality of life using EPIC-26 prior to radiation therapy and over time in subjects with prostate cancer who have received PSMA-PET/MRI to define radiotherapy targets.
Screened Subjects
Measuring the proportion of screened subjects who are enrolled on the study
Patient-reported quality of life using Prostate Cancer Symptom Indices (PCSI)
Measuring patient-reported quality of life using PCSI prior to radiation therapy and over time in subjects with prostate cancer who have received PSMA-PET/MRI to define radiotherapy targets.

Full Information

First Posted
January 21, 2020
Last Updated
January 31, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04243941
Brief Title
PSMA-PET/MRI Low- and Intermediate-Risk Prostate Cancer
Official Title
LCCC 1917: Dose Escalation of Low and Intermediate Risk Localized Prostate Cancer Using 68Ga-HBED-CC PSMA-PET/MRI and Stereotactic Body Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
May 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to determine the safety of using PSMA-PET/mpMRI to define radiotherapy targets, while meeting all current planning criteria. This study also intends to determine the feasibility of performing stereotactic body radiation therapy with simultaneous integrated boost on the dominant intra-prostatic lesions while meeting all current planning criteria.
Detailed Description
This study aims to determine if multi-parametric magnetic resonance imaging (mpMRI) and prostate-specific membrane antigen-positron emission tomography (PSMA-PET) imaging can help optimize the placement of the high dose inhomogeneity characterizing stereotactic body radiation therapy. All radiation plans have "hot spots" of radiation, and in current practice these regions are randomly located. This study will focus those hot spots on regions determined by mpMRI + PSMA-PET to have visible tumor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PMSA-PET/MRI
Arm Type
Experimental
Arm Description
Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment
Intervention Type
Drug
Intervention Name(s)
68Ga-HBED-CC-PSMA
Other Intervention Name(s)
gallium Ga 68-labeled PSMA-11
Intervention Description
Radioactive tracer used during imaging to help detect PSMA expressing tumor cells
Primary Outcome Measure Information:
Title
Genitourinary and gastrointestinal toxicity 12 months post-treatment
Description
Grade 2+ GU/GI late toxicity as classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 at 12 months after radiation therapy
Time Frame
Baseline to 1 year post-treatment
Title
Feasibility of meeting specified dose constraints
Description
Proportion of subjects who meet these criteria: Boost dose coverage: DIL D95% ≥ 44 Gy Dose constraints: Urethra Dmax < 40 Gy Bladder Dmax < 45.6 Gy Bladder D10cc < 41.8 Gy Rectum Dmax < 38 Gy Rectal Mucosa D1% < 28.5 Gy Sigmoid Colon Dmax < 28.5 Gy
Time Frame
Baseline to 1 year post-treatment
Secondary Outcome Measure Information:
Title
Acute and late genitourinary and gastrointestinal toxicity
Description
GU and GI toxicity as classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Will be measured during radiation therapy and at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after radiotherapy.
Time Frame
Baseline to 5 years post-treatment
Title
Biochemical control using Prostate-Specific Antigen (PSA) levels
Description
Biochemical control will be defined according to the Phoenix criteria at 2 and 5 years after radiation therapy
Time Frame
Baseline to 5 years post-treatment
Title
Patient-reported quality of life using the Expanded Prostate Cancer Index Composite (EPIC-26)
Description
Measuring patient-reported quality of life using EPIC-26 prior to radiation therapy and over time in subjects with prostate cancer who have received PSMA-PET/MRI to define radiotherapy targets.
Time Frame
Baseline to 5 years post-treatment
Title
Screened Subjects
Description
Measuring the proportion of screened subjects who are enrolled on the study
Time Frame
Through study completion, average of 2 years
Title
Patient-reported quality of life using Prostate Cancer Symptom Indices (PCSI)
Description
Measuring patient-reported quality of life using PCSI prior to radiation therapy and over time in subjects with prostate cancer who have received PSMA-PET/MRI to define radiotherapy targets.
Time Frame
Baseline to 5 years post-treatment

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male participants only, since this is a prostate cancer study
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information Male subjects ≥ 18 years of age Histologically confirmed prostate adenocarcinoma Low or favorable intermediate risk, based on the NCCN criteria Subject has adequate performance status as defined by ECOG performance status of 0-2 Subject is willing and able to comply with the protocol as determined by the Treating Investigator Subject speaks English (quality of life instrument is validated in English) Exclusion Criteria: Contraindications for MRI Other prior or concomitant malignancies, with the exception of: non-melanoma skin cancer other cancer for which the subject has been disease free for ≥5 years before the first study treatment and of low potential risk for recurrence Inflammatory bowel disease Previous transurethral resection of the prostate (TURP) or surgery of the prostate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Panayiotis Mavroidis, PhD
Phone
984-974-8438
Email
panayiotis_mavroidis@med.unc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Gadre
Phone
984-215-5425
Email
sarah_gadre@med.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Repka, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
Description
University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Learn more about this trial

PSMA-PET/MRI Low- and Intermediate-Risk Prostate Cancer

We'll reach out to this number within 24 hrs