Clinical trial NCT04243941: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Genitourinary and gastrointestinal toxicity 12 months post-treatment
timeFrame: Baseline to 1 year post-treatment
measure: Feasibility of meeting specified dose constraints
timeFrame: Baseline to 1 year post-treatment
Secondary outcomes:
measure: Acute and late genitourinary and gastrointestinal toxicity
timeFrame: Baseline to 5 years post-treatment
measure: Biochemical control using Prostate-Specific Antigen (PSA) levels
timeFrame: Baseline to 5 years post-treatment
measure: Patient-reported quality of life using the Expanded Prostate Cancer Index Composite (EPIC-26)
timeFrame: Baseline to 5 years post-treatment
measure: Screened Subjects
timeFrame: Through study completion, average of 2 years
measure: Patient-reported quality of life using Prostate Cancer Symptom Indices (PCSI)
timeFrame: Baseline to 5 years post-treatment
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Michael Repka, MD
role: PRINCIPAL_INVESTIGATOR
References: