Stereotactic Body Radiation Therapy for Low and Intermediate Risk Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03554369|
Recruitment Status : Active, not recruiting
First Posted : June 13, 2018
Last Update Posted : June 3, 2019
There are two separate phases of this study. The purpose of the phase-I is to initially find a potent but reasonably safe dose of a stereotactic body radiation therapy (SBRT) for treating prostate cancer. Once this potent but reasonably safe dose is found, the phase-II will treat additional patients with SBRT to see what effects (good and bad) it has on prostate cancer.
- Primary objective: To escalate the dose of stereotactic radiotherapy to a tumorcidal dose without exceeding the maximum tolerated dose in patients with organ confined prostate cancer.
- Secondary objective: To determine the dose limiting toxicity (DLT) (if the maximum tolerated dose is reached)
- Primary objective: To determine the late severe grade 3-5 Gu and Gi toxicity at nine months from the start of the protocol treatment (graded base on the CTCae v3.0)
- Secondary objective: To determine the 2 year biochemical Prostate Specific Antigen (PSA) control (freedom from PSA failure), disease free and overall survival, local control, freedom from distant metastases, and the incidence of high grade adverse events of any type from the therapy in the treated patients in order to determine if the therapy is promising enough for further clinical investigation.
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Prostate||Radiation: Prostate SBRT||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I and II Study of Stereotactic Body Radiation Therapy (SBRT) for Low and Intermediate Risk Prostate Cancer|
|Actual Study Start Date :||July 11, 2006|
|Actual Primary Completion Date :||December 20, 2011|
|Estimated Study Completion Date :||December 20, 2021|
Prostate SBRT will be delivered in 5 fractions using intensity-modulated radiotherapy planning techniques.
Radiation: Prostate SBRT
Patients will receive 45Gy in 5 fractions of radiation. A minimum of 36 hours and a maximum of 8 days should separate each treatment. No more than 3 fractions will be delivered per week (7 consecutive days). Total dose will depend on the phase of the study
- Dose Limiting Toxicity (DLT) [ Time Frame: 1-2 Years ]Severity or Toxicity will be graded using the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v. 3.0. A dose- limiting toxicity (DLT) is any treatmentrelated grade 3, 4, or 5 toxicity in the following categories gastrointestinal, renal, genito-urinary, sexual- reproductive, or neurological constitutional symptoms. CTCAE V3.0 along with grades 1-5 is provided in the link for reference (https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf).
- Acute & Delayed Genitourinary (GU) and Gastrointestinal (GI) toxicity [ Time Frame: 10 Years ]Severity or Toxicity will be assessed according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 3.0. Dose adjustments should be made according to the system showing the greatest degree of toxicity. The consequences of gastointestinal/renal/genitourinary/sexual and reproductive toxicity should all be graded 1-5 according to the Common Terminology Criteria For Adverse Events (CTCAE), version 3.0 occurring prior to 270 days from the start of protocol treatment. Other treatment related toxicity attributed to the therapy will be captured, recorded and the consequences of should all be graded 1-5 according to the Common Terminology Criteria For Adverse Events (CTCAE). CTCAE V3.0 along with grades 1-5 is provided in the link for reference (https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf).
- Biochemical failure RTOG-ASTRO definition (also known as Phoenix definition) [ Time Frame: 10 Years ]Increase in PSA greater than 2ng/ml above the patients lowest PSA level (nadir) after treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554369
|United States, Texas|
|UT Southwestern Cancer Center|
|Dallas, Texas, United States, 75235|