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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Simultaneously integrated boost or sequential integrated boost
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huojun Zhang, PhD | Contact | 021-31162222 | chyyzhj@163.com | |
| Xianzhi Zhao, MD | Contact | 021-31162222 | zhxzh0007@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36507781 | Derived | 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. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D000726 | Androgen Antagonists |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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|
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| 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |