NCT04599699

Integrated Boost to the Dominant Intraprostatic Nodule Based on Ga-68 PSMA PET/MR Study of SBRT With Prostate Cancer

A Phase I Integrated Boost to the Dominant Intraprostatic Nodule Based on Ga-68 Prostate-Specific Membrane Antigen (PSMA) PET/MR Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to test the safety and efficacy of integrated boost to the dominant intraprostatic nodule based on Ga-68 Prostate-Specific Membrane Antigen (PSMA) PET/MR in Stereotactic Body Radiation Therapy (SBRT) in localized prostate carcinoma in patients for whom the standard treatment is the irradiation of the entire prostate gland with or without seminal vesicles accompanied or not by hormonal therapy.

Detailed description

Radiotherapy is considered standard of care treatment for prostate cancer. In light of the accumulating clinical evidence favoring the use of hypo fractionation, SBRT regimen might constitute a much more convenient non-invasive and highly efficient outpatient therapy. Although the proposed extreme hypofractionated radiotherapy approach was expected to provide excellent local control of the primary prostate cancer, a proportion of patients with intermediate- or high-risk disease may have recurrences with local recurrence or distant metastasis in the future, requiring strategies to minimize systemic disease. Ga-68 PSMA PET/MR has high accuracy in the diagnosis and staging of prostate cancer. In this protocol, pretreatment Ga-68 PSMA PET/MR and CT scanning were performed in all patients as well as the imaging fusion before delineating the target. This study would explore the simultaneously integrated boost or equential integrated boost to the dominant intraprostatic nodule based on Ga-68 PSMA PET/MR in SBRT.

Conditions

• Treatment

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiation Therapy (SBRT)	Very Low, Low, favorable, or Good Prognostic Intermediate prostate cancer:SBRT; Unfavorable, or Poor Prognostic Intermediate prostate cancer: SBRT accompanied 4 months ADT;High or Very High prostate cancer: SBRT accompanied 2 years ADT.

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-05-01
• Completion: 2023-05-01
• First posted: 2020-10-23
• Last updated: 2020-10-23

Locations

1 site across 1 country: China