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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04243941
• Other study ID #: LCCC1917
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 29, 2022
• Est. completion date: February 7, 2024

Study information

• Verified date: March 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 7, 2024
• Est. primary completion date: February 7, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 68Ga-HBED-CC-PSMA
Radioactive tracer used during imaging to help detect PSMA expressing tumor cells

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline to 1 year post-treatment
Primary	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	Baseline to 1 year post-treatment
Secondary	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.	Baseline to 5 years post-treatment
Secondary	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	Baseline to 5 years post-treatment
Secondary	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.	Baseline to 5 years post-treatment
Secondary	Screened Subjects	Measuring the proportion of screened subjects who are enrolled on the study	Through study completion, average of 2 years
Secondary	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.	Baseline to 5 years post-treatment

External Links

•   University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials