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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Treatment
• Intervention / Treatment: Radiation: Stereotactic Body Radiation Therapy (SBRT)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huojun Zhang, PhD; Phone Number: 021-31162222; Email: chyyzhj@163.com
• Study Contact Backup: Name: Xianzhi Zhao, MD; Phone Number: 021-31162222; Email: zhxzh0007@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Shanghai Changhai Hospital
      • Contact: Huojun Zhang, PhD; Phone Number: 021-31162222; Email: chyyzhj@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the prostate
• tumor clinical stage cT1-3N0M0 according to AJCC TNM 2017
• Without any treatment of prostate cancer including radiotherapy, ADT, chemotherapy, focal treatment, etc.
• With the examination of Ga-68 PSMA PET/MR
• International Prostate Symptom Score(IPSS）<15 (alpha blockers allowed), without severe urethral obstruction symptoms
• ECOG performance status 0-2
• Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures

Exclusion Criteria:

• Prior pelvic RT
• A tumor located at less than 3 mm from the urethra or rectum when measured at the MRI
• Tumor clinical stage cT4, with metastases including bone, lymph nodes or organ metastasis
• Histologically confirmed neuroendocrine tumor or small cell carcinoma of the prostate
• Severe or active co-morbidity likely to impact on the advisability of SBRT like severe liver or kidney dysfunction, etc.
• Patients with other malignancies, or acute or other severe infections, with ulcerative colitis, inflammatory bowel disease, etc.
• Patients who have participated in other clinical trials for less than three months
• Patients have acute prostatitis or chronic prostatitis with urinary symptoms
• Urine routine indicates obvious urinary system infection and no significant improvement after anti-infective treatment, or conversion to recurrent urinary system infection
• Unsuitable to participate in this clinical trial judged by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 1; Simultaneously integrated boost or sequential integrated boost; Simultaneously integrated boost Prostate tumor: starting dose 8.7 Gy per fraction in 5 fractions (total 43.5 Gy) Prostate gland: fixed prophylactic tumoricidal dose 7.25 Gy per fraction in 5 fractions. Total 36.25 Gy.; Sequential integrated boost Prostate tumor: starting dose 7.25 Gy per fraction in 6 fractions (total 43.5 Gy) Prostate gland: fixed prophylactic tumoricidal dose 7.25 Gy per fraction in 5 fractions. Total 36.25 Gy.

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.; Other Names: androgen deprivation therapy (ADT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Probability of Acute genitourinary (GU) , gastrointestinal (GI) toxicity and erectile dysfunction	Acute genitourinary (GU) , gastrointestinal (GI) toxicity and erectile dysfunction (ED) (grade 2 or more) according to the NCI CTCAE v4.0.	90 days after the first fraction of radiotherapy treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Probability of Chronic genitourinary (GU) , gastrointestinal (GI) toxicity and erectile dysfunction (ED)	Chronic genitourinary (GU) , gastrointestinal (GI) toxicity and erectile dysfunction (ED) (grade 2 or more) according to the NCI CTCAE v4.0.	> 90 days and up to 3 years from the start of protocol treatment
1-year Biochemical Progression-free Survival (bPFS)	Biochemical Progression-free Survival (bPFS)	Assessment at 1-year
1-year Local Progression-Free-Survival(LPFS)	Local Progression-Free-Survival(LPFS)	Assessment at 1-year
1-year Distant Metastasis Free Survival(DMFS)	Distant Metastasis Free Survival(DMFS)	Assessment at 1-year
1-year Overall Survival (OS)	Overall Survival (OS)	Assessment at 1-year

Collaborators and Investigators

• Sponsor: Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: October 10, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: prostate cancer; SBRT; Ga-68 PSMA PET/MR
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens
• Other Study ID Numbers: Changhai Hospi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No