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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2020
CompletedFirst Posted
Study publicly available on registry
October 23, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedOctober 23, 2020
October 1, 2020
1.5 years
October 10, 2020
October 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
The Probability of Chronic genitourinary (GU) , gastrointestinal (GI) toxicity and erectile dysfunction (ED)
> 90 days and up to 3 years from the start of protocol treatment
1-year Biochemical Progression-free Survival (bPFS)
Assessment at 1-year
1-year Local Progression-Free-Survival(LPFS)
Assessment at 1-year
1-year Distant Metastasis Free Survival(DMFS)
Assessment at 1-year
1-year Overall Survival (OS)
Assessment at 1-year
Study Arms (1)
1
EXPERIMENTALSimultaneously 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
Related Publications (1)
Zhao X, Zhu X, Cheng C, Jiang L, Ye Y, Cao Y, Li Y, Zuo C, Zhang H. Protocol of the integrated boost to the dominant intraprostatic nodule in stereotactic body radiation therapy for localized prostate cancer. Future Oncol. 2022 Dec 12. doi: 10.2217/fon-2022-0590. Online ahead of print.
PMID: 36507781DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
October 10, 2020
First Posted
October 23, 2020
Study Start
November 1, 2020
Primary Completion
May 1, 2022
Study Completion
May 1, 2023
Last Updated
October 23, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share