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

NCT04243941 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: LCCC1917
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Acute and late genitourinary and gastrointestinal toxicity

  Baseline to 5 years post-treatment

• Biochemical control using Prostate-Specific Antigen (PSA) levels

  Baseline to 5 years post-treatment

• Patient-reported quality of life using the Expanded Prostate Cancer Index Composite (EPIC-26)

  Baseline to 5 years post-treatment

• Screened Subjects

  Through study completion, average of 2 years

• Patient-reported quality of life using Prostate Cancer Symptom Indices (PCSI)

  Baseline to 5 years post-treatment

Study Arms (1)

PMSA-PET/MRI

EXPERIMENTAL

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

Drug: 68Ga-HBED-CC-PSMA

Interventions

68Ga-HBED-CC-PSMA DRUG

Radioactive tracer used during imaging to help detect PSMA expressing tumor cells

Also known as: gallium Ga 68-labeled PSMA-11

PMSA-PET/MRI

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male participants only, since this is a prostate cancer study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Michael Repka, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 28, 2020
• Study Start: November 29, 2022
• Primary Completion: February 7, 2024
• Study Completion: February 7, 2024
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share