Radiation and Androgen Ablation for Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01517451|
Recruitment Status : Active, not recruiting
First Posted : January 25, 2012
Last Update Posted : November 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Prostate||Radiation: Radiation Therapy Drug: Androgen Deprivation Therapy (ADT)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate|
|Actual Study Start Date :||May 22, 2013|
|Estimated Primary Completion Date :||May 22, 2021|
|Estimated Study Completion Date :||May 22, 2023|
Experimental: Radiation with Androgen Deprivation Therapy (ADT)
This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens.
Radiation: Radiation Therapy
7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions)
Drug: Androgen Deprivation Therapy (ADT)
Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT.
- Biochemical failure free-rate [ Time Frame: 1, 2, 3, 6 12, 18. 24, 30, 36 mont, 4 year and 5 year follow-up points after treatment has been completed ]To assess 5-year biochemical failure free rate (BFFR) associated with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently.
- Various Control Rate Assessments [ Time Frame: 1 year ]Assess biochemical, clinical, and pathologic control rates associated with the combined hypofractionated dose regimen and ADT.
- Dose Volume/ Imaging Data Assessments [ Time Frame: 1 year ]Collect dose/volume and imaging data to allow normal tissue complication probability modeling and targeting assessment for patients treated with hypofractionated radiation therapy.
- Biomarker Studies [ Time Frame: 1 year ]Collect whole blood to perform correlative studies for serum cytokine profiling and future biomarker studies.
- Gastrointestinal (GI) and Genitourinary (GU toxicity) assessment [ Time Frame: 1 year ]1) Assess the incidence of grade 3 or greater GU (genitourinary) and GI (gastrointestinal) toxicity with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently.
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): NCT01517451
|United States, District of Columbia|
|Sibley Memorial Hospital|
|Washington, District of Columbia, United States, 20016|
|United States, Maryland|
|The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|Bethesda, Maryland, United States, 20814|
|Principal Investigator:||Phuoc Tran, M.D.||Johns Hopkins University|