Treatment Clinical Trial
— SBRTOfficial 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
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | May 1, 2023 |
Est. primary completion date | May 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Changhai Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Changhai Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 1-year Biochemical Progression-free Survival (bPFS) | Biochemical Progression-free Survival (bPFS) | Assessment at 1-year | |
Secondary | 1-year Local Progression-Free-Survival(LPFS) | Local Progression-Free-Survival(LPFS) | Assessment at 1-year | |
Secondary | 1-year Distant Metastasis Free Survival(DMFS) | Distant Metastasis Free Survival(DMFS) | Assessment at 1-year | |
Secondary | 1-year Overall Survival (OS) | Overall Survival (OS) | Assessment at 1-year |
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