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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00067963 | Other Identifier | JHMIRB |
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A study to see how effective and tolerable radiation therapy along with androgen deprivation therapy is in treating prostate cancer.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation with Androgen Deprivation Therapy (ADT) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Radiation | 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical Failure Free-rate (BFFR) Associated With the Combined Hypofractionated Dose Regimen and Androgen Deprivation Therapy (ADT). | 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. BFFR is defined as binary indicator whether PSA has increased by 2 ng/ml or more above the nadir PSA any time before the end of 5 years as the number of events. | From consent up to 5 years post treatment completion |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity as Assessed as Incidence of Grade 3 or Greater Gastrointestinal (GI) and Genitourinary (GU) Adverse Events | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Song, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | United States | ||
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Therapy: 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) Androgen Deprivation Therapy (ADT): Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Therapy: 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) Androgen Deprivation Therapy (ADT): Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Biochemical Failure Free-rate (BFFR) Associated With the Combined Hypofractionated Dose Regimen and Androgen Deprivation Therapy (ADT). | 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. BFFR is defined as binary indicator whether PSA has increased by 2 ng/ml or more above the nadir PSA any time before the end of 5 years as the number of events. | Posted | Number | progression events | From consent up to 5 years post treatment completion |
|
From enrollment up to 5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiation With Androgen Deprivation Therapy (ADT) | Patients receiving combined regimen of radiation therapy 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment | Pt. missed 4 year f/u due to 3-day hospitalization for cellulitis and continued outpatient IV abx for 28 days completed 2/29/2020. Also reported hyperglycemia Grade 4, also documented. History of DM on insulin with Charcot foot and severe neuropathy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erectile disfunction | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment | Genitourinary AE |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Song | Johns Hopkins Department of Radiation Oncology | 410-502-5875 | dsong2@jh.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2021 | Jan 12, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D000726 | Androgen Antagonists |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
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| Androgen Deprivation Therapy (ADT) | Drug | Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT. |
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| Consent to up to 5 years of follow-up or biochemical failure. |
| Overall Survival Rate | Assess clinical control rate by measuring the Overall Survival (OS) which is defined as the percentage of participants who completed the study that lived from time of treatment until death from any cause. | Start of treatment up to 5 years |
| Number of Patients Who Completed Blood Collection of Whole Blood for Future Research | Biomarker studies. Number of patients who completed blood collection of whole blood for future research. | Up to 2 years post treatment |
| Self-reported Patient Quality of Life Data Using the International Prostate Symptom Score (IPSS). | The International Prostate Symptom Score (IPSS) is a useful subjective assessment tool for Benign prostatic hyperplasia (BPH) patients; it is a modification of the American Urological Association (AUA) Symptom Index. The questionnaire assesses degree of Lower Urinary Tract Symptoms (LUTS) and quality of life. Patients can fill out the IPSS form before examinations, but minimal interference from health care providers must be ensured. Total score range 0-35; A score of 7 or less is mildly symptomatic, 8 to 19 is moderately symptomatic, and 20 to 35 is severely symptomatic. | Measured at baseline and at 3, 12, 24 and 36 months post treatment |
| Patient Reported Sexual Health Inventory for Men (SHIM), a Self-reported Quality of Life Assessment | The SHIM serves several key functions within clinical and research settings. Its core purpose involves screening for and evaluating the severity of erectile dysfunction (ED). Total score range 5 to 25; higher scores indicate better erectile function. A total score of 21 or less indicates erectile dysfunction. 22-25: No erectile dysfunction, 17-21: Mild ED, 12-16: Mild-to-moderate ED, 8-11: Moderate ED, 5-7: Severe ED. | Baseline and at 3,12, 24 and 36 months follow-up |
| The Expanded Prostate Cancer Index Composite 26 (EPIC). Self-reported Quality of Life Assessment of Sexual Health | The EPIC-26 (Expanded Prostate Cancer Index Composite-Short Form) is a validated questionnaire for measuring sexual health related quality of life. Scores range from 1 to 100, with higher scores being better score. | 3,12, 24 and 36 months follow-up |
| Baltimore |
| Maryland |
| 21231 |
| United States |
| Suburban Hospital | Bethesda | Maryland | 20814 | United States |
| Participants |
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| Age, Continuous | Median | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Toxicity as Assessed as Incidence of Grade 3 or Greater Gastrointestinal (GI) and Genitourinary (GU) Adverse Events | 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. | Posted | Number | events | Consent to up to 5 years of follow-up or biochemical failure. |
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| Secondary | Overall Survival Rate | Assess clinical control rate by measuring the Overall Survival (OS) which is defined as the percentage of participants who completed the study that lived from time of treatment until death from any cause. | Posted | Count of Participants | Participants | Start of treatment up to 5 years |
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| Secondary | Number of Patients Who Completed Blood Collection of Whole Blood for Future Research | Biomarker studies. Number of patients who completed blood collection of whole blood for future research. | Posted | Count of Participants | Participants | Up to 2 years post treatment |
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| Secondary | Self-reported Patient Quality of Life Data Using the International Prostate Symptom Score (IPSS). | The International Prostate Symptom Score (IPSS) is a useful subjective assessment tool for Benign prostatic hyperplasia (BPH) patients; it is a modification of the American Urological Association (AUA) Symptom Index. The questionnaire assesses degree of Lower Urinary Tract Symptoms (LUTS) and quality of life. Patients can fill out the IPSS form before examinations, but minimal interference from health care providers must be ensured. Total score range 0-35; A score of 7 or less is mildly symptomatic, 8 to 19 is moderately symptomatic, and 20 to 35 is severely symptomatic. | Patients with data collected | Posted | Mean | Standard Deviation | score on a scale | Measured at baseline and at 3, 12, 24 and 36 months post treatment |
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| Secondary | Patient Reported Sexual Health Inventory for Men (SHIM), a Self-reported Quality of Life Assessment | The SHIM serves several key functions within clinical and research settings. Its core purpose involves screening for and evaluating the severity of erectile dysfunction (ED). Total score range 5 to 25; higher scores indicate better erectile function. A total score of 21 or less indicates erectile dysfunction. 22-25: No erectile dysfunction, 17-21: Mild ED, 12-16: Mild-to-moderate ED, 8-11: Moderate ED, 5-7: Severe ED. | Patients with data collected | Posted | Mean | Standard Deviation | score on a scale | Baseline and at 3,12, 24 and 36 months follow-up |
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| Secondary | The Expanded Prostate Cancer Index Composite 26 (EPIC). Self-reported Quality of Life Assessment of Sexual Health | The EPIC-26 (Expanded Prostate Cancer Index Composite-Short Form) is a validated questionnaire for measuring sexual health related quality of life. Scores range from 1 to 100, with higher scores being better score. | At each timepoint the number of participants varies based on patient data collected for the EPIC assessment. | Posted | Mean | Standard Deviation | score on a scale | 3,12, 24 and 36 months follow-up |
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| 0 |
| 45 |
| 2 |
| 45 |
| 4 |
| 45 |
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| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | The patient had a syncopal episode while working out at the gym. Patient was taken by ambulance to the Sibley ED, where he was evaluated for 2 hours and given IV fluids. The event most likely caused by dehydration. Was referred to cardiology. |
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| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| 12 month Follow-up |
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| 24 month Follow-up |
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| 36 month Follow-up |
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| 12 months |
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| 24 months |
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| 36 months |
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| 24 months |
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| 36 months |
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