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

Primary Purpose

Treatment

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy (SBRT)
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment focused on measuring SBRT, prostate cancer, Ga-68 PSMA PET/MR

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Changhai HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
1-year Biochemical Progression-free Survival (bPFS)
Biochemical Progression-free Survival (bPFS)
1-year Local Progression-Free-Survival(LPFS)
Local Progression-Free-Survival(LPFS)
1-year Distant Metastasis Free Survival(DMFS)
Distant Metastasis Free Survival(DMFS)
1-year Overall Survival (OS)
Overall Survival (OS)

Full Information

First Posted
October 10, 2020
Last Updated
October 22, 2020
Sponsor
Changhai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04599699
Brief Title
Integrated Boost to the Dominant Intraprostatic Nodule Based on Ga-68 PSMA PET/MR Study of SBRT With Prostate Cancer
Acronym
SBRT
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Anticipated)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment
Keywords
SBRT, prostate cancer, Ga-68 PSMA PET/MR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy (SBRT)
Other Intervention Name(s)
androgen deprivation therapy (ADT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Probability of Acute genitourinary (GU) , gastrointestinal (GI) toxicity and erectile dysfunction
Description
Acute genitourinary (GU) , gastrointestinal (GI) toxicity and erectile dysfunction (ED) (grade 2 or more) according to the NCI CTCAE v4.0.
Time Frame
90 days after the first fraction of radiotherapy treatment
Secondary Outcome Measure Information:
Title
The Probability of Chronic genitourinary (GU) , gastrointestinal (GI) toxicity and erectile dysfunction (ED)
Description
Chronic genitourinary (GU) , gastrointestinal (GI) toxicity and erectile dysfunction (ED) (grade 2 or more) according to the NCI CTCAE v4.0.
Time Frame
> 90 days and up to 3 years from the start of protocol treatment
Title
1-year Biochemical Progression-free Survival (bPFS)
Description
Biochemical Progression-free Survival (bPFS)
Time Frame
Assessment at 1-year
Title
1-year Local Progression-Free-Survival(LPFS)
Description
Local Progression-Free-Survival(LPFS)
Time Frame
Assessment at 1-year
Title
1-year Distant Metastasis Free Survival(DMFS)
Description
Distant Metastasis Free Survival(DMFS)
Time Frame
Assessment at 1-year
Title
1-year Overall Survival (OS)
Description
Overall Survival (OS)
Time Frame
Assessment at 1-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huojun Zhang, PhD
Phone
021-31162222
Email
chyyzhj@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xianzhi Zhao, MD
Phone
021-31162222
Email
zhxzh0007@163.com
Facility Information:
Facility Name
Shanghai Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huojun Zhang, PhD
Phone
021-31162222
Email
chyyzhj@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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