Adenocarcinoma of the Prostate
Conditions
Brief summary
A study to see how effective and tolerable radiation therapy along with androgen deprivation therapy is in treating prostate cancer.
Detailed description
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.
Interventions
RADIATIONRadiation Therapy
7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions)
DRUGAndrogen Deprivation Therapy (ADT)
Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT.
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed, locally confined adenocarcinoma of the prostate * Patient must fit D'Amico intermediate risk criteria by clinical stage (T2b-T2c), PSA (prostatic specific antigen) (10-20 ng/mL), and/or Gleason score (Gleason 7). * The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer. * Signed study-specific consent form prior to registration
Exclusion criteria
* Stage T3-4 disease. * Gleason 8 or higher score. * PSA \> 20 ng/ml. * IPSS (International Prostate Symptom Score) \> 15 * Clinical or Pathological Lymph node involvement (N1). * Evidence of distant metastases (M1). * Radical surgery for carcinoma of the prostate. * Previous Chemotherapy, unless intervention was greater than 5 years from beginning treatment for current prostate cancer. * Previous pelvic radiation therapy. * Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years. * History of inflammatory bowel disease. * Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up. * Myocardial infarction or cerebrovascular accident within one year from consultation, or other major vascular risk factor which would prevent a patient from receiving appropriate androgen deprivation therapy.11 * Liver function tests (LFTs) greater than twice the upper limit of normal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical Failure Free-rate (BFFR) Associated With the Combined Hypofractionated Dose Regimen and Androgen Deprivation Therapy (ADT). | From consent up to 5 years post treatment completion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity as Assessed as Incidence of Grade 3 or Greater Gastrointestinal (GI) and Genitourinary (GU) Adverse Events | Consent to up to 5 years of follow-up or biochemical failure. | 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. |
| Overall Survival Rate | Start of treatment up to 5 years | 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. |
| Number of Patients Who Completed Blood Collection of Whole Blood for Future Research | Up to 2 years post treatment | Biomarker studies. Number of patients who completed blood collection of whole blood for future research. |
| Self-reported Patient Quality of Life Data Using the International Prostate Symptom Score (IPSS). | Measured at baseline and at 3, 12, 24 and 36 months post treatment | 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. |
| Patient Reported Sexual Health Inventory for Men (SHIM), a Self-reported Quality of Life Assessment | Baseline and at 3,12, 24 and 36 months follow-up | 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. |
| The Expanded Prostate Cancer Index Composite 26 (EPIC). Self-reported Quality of Life Assessment of Sexual Health | 3,12, 24 and 36 months follow-up | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel Song, M.D.
Johns Hopkins University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants |
| Age, Continuous | 65 Years |
| Region of Enrollment United States | 44 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 45 |
| other Total, other adverse events | 4 / 45 |
| serious Total, serious adverse events | 2 / 45 |
Outcome results
None listed