Radiation and Androgen Ablation for Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01517451|
Recruitment Status : Active, not recruiting
First Posted : January 25, 2012
Last Update Posted : December 4, 2017
|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|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2020|
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.
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|