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Hormone Therapy
Radiation + Hormone Therapy for Prostate Cancer
Baltimore, MD
Phase 1 & 2
Waitlist Available
Led By Daniel Song, M.D.
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed, locally confined adenocarcinoma of the prostate
The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer
Must not have
Gleason 8 or higher score
Clinical or Pathological Lymph node involvement (N1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 2, 3, 6 12, 18. 24, 30, 36 mont, 4 year and 5 year follow-up points after treatment has been completed
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if adding radiation to hormone therapy improves outcomes for prostate cancer patients.
See full description
Who is the study for?
Men with intermediate-risk prostate cancer, specifically those with a clinical stage of T2b-T2c, PSA levels between 10-20 ng/mL, or Gleason score of 7. Participants must have chosen external beam radiation as their treatment and not had previous radical prostate surgery, chemotherapy within the last five years for another cancer, pelvic radiation therapy, metastases or certain other cancers.Check my eligibility
What is being tested?
The trial is testing how well men with prostate cancer respond to a combination of Androgen Deprivation Therapy (ADT) and Radiation Therapy. It aims to determine the effectiveness and tolerability of this combined approach in treating locally confined adenocarcinoma of the prostate.See study design
What are the potential side effects?
Possible side effects include hot flashes, reduced sexual desire or activity due to ADT; skin irritation, fatigue from radiation therapy; plus potential long-term impacts on urinary and bowel function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is confirmed and has not spread outside the prostate.
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I have chosen external beam radiation to treat my prostate cancer.
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My prostate cancer is at an intermediate stage with specific PSA levels and Gleason score.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My prostate cancer has a Gleason score of 8 or higher.
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Select...
My cancer has spread to nearby lymph nodes.
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My cancer has spread to distant parts of my body.
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Select...
I have had major surgery for prostate cancer.
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My cancer is at an advanced local stage.
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I have had radiation therapy in the pelvic area before.
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I have a history of inflammatory bowel disease.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 2, 3, 6 12, 18. 24, 30, 36 mont, 4 year and 5 year follow-up points after treatment has been completed
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 2, 3, 6 12, 18. 24, 30, 36 mont, 4 year and 5 year follow-up points after treatment has been completed
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Biochemical failure free-rate
Secondary study objectives
Biomarker Studies
Dose Volume/ Imaging Data Assessments
Gastrointestinal (GI) and Genitourinary (GU toxicity) assessment
+1 moreSide effects data
From 2012 Phase 3 trial • 522 Patients • NCT0024256723%
PROSTATIC SPECIFIC ANTIGEN INCREASED
21%
BACK PAIN
20%
CONSTIPATION
17%
ARTHRALGIA
16%
PAIN IN EXTREMITY
11%
NAUSEA
11%
BONE PAIN
11%
ANAEMIA
10%
BLOOD CREATININE INCREASED
10%
MUSCULOSKELETAL PAIN
9%
OEDEMA PERIPHERAL
9%
HOT FLUSH
9%
DECREASED APPETITE
9%
DIARRHOEA
8%
UPPER RESPIRATORY TRACT INFECTION
8%
MUSCULOSKELETAL CHEST PAIN
8%
FATIGUE
8%
URINARY TRACT INFECTION
8%
PROSTATE CANCER
7%
WEIGHT DECREASED
7%
INSOMNIA
7%
DYSPNOEA
6%
DYSURIA
6%
DISEASE PROGRESSION
6%
NASOPHARYNGITIS
6%
DIZZINESS
6%
COUGH
6%
FALL
6%
MYALGIA
5%
VOMITING
5%
ASTHENIA
5%
ABDOMINAL PAIN
5%
INFLUENZA LIKE ILLNESS
5%
PAIN
5%
MUSCULAR WEAKNESS
5%
NOCTURIA
5%
LOWER RESPIRATORY TRACT INFECTION
4%
METASTATIC PAIN
4%
WEIGHT INCREASED
4%
HAEMATURIA
4%
HYPERTENSION
4%
HYPOCALCAEMIA
4%
SKIN LACERATION
4%
THROMBOCYTOPENIA
3%
MUSCULOSKELETAL DISCOMFORT
3%
MUSCULOSKELETAL STIFFNESS
3%
PROSTATE CANCER METASTATIC
3%
PARAESTHESIA
3%
POLLAKIURIA
3%
PELVIC PAIN
3%
NECK PAIN
3%
HEADACHE
3%
URINARY RETENTION
3%
DYSPEPSIA
3%
PYREXIA
2%
LYMPHADENOPATHY
2%
DEATH
2%
DEHYDRATION
2%
METASTASES TO BONE
2%
CEREBRAL HAEMORRHAGE
2%
RENAL FAILURE ACUTE
2%
DEPRESSED MOOD
2%
HYDRONEPHROSIS
2%
MUSCLE SPASMS
2%
HYPOAESTHESIA
2%
HYPOPHOSPHATAEMIA
2%
SEPSIS
2%
BRONCHOPNEUMONIA
2%
NEUTROPENIA
2%
ABDOMINAL PAIN UPPER
1%
LOBAR PNEUMONIA
1%
GASTROENTERITIS
1%
CARDIAC FAILURE CONGESTIVE
1%
MYOCARDIAL INFARCTION
1%
CHOLELITHIASIS
1%
PNEUMONIA
1%
METASTASES TO LUNG
1%
METASTASES TO LIVER
1%
CEREBRAL INFARCTION
1%
MALIGNANT NEOPLASM PROGRESSION
1%
METASTASES TO CENTRAL NERVOUS SYSTEM
1%
RENAL IMPAIRMENT
1%
RESPIRATORY FAILURE
1%
BONE MARROW FAILURE
1%
ANGINA PECTORIS
1%
ATRIAL FIBRILLATION
1%
CONCOMITANT DISEASE PROGRESSION
1%
FEMUR FRACTURE
1%
HYPOPHAGIA
1%
CONVULSION
1%
RESPIRATORY ARREST
1%
CHEST PAIN
1%
SPINAL COMPRESSION FRACTURE
1%
PLATELET COUNT DECREASED
1%
CEREBROVASCULAR ACCIDENT
1%
PARAPLEGIA
1%
SPINAL CORD COMPRESSION
1%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
1%
CARDIAC ARREST
1%
UPPER GASTROINTESTINAL HAEMORRHAGE
1%
BLOOD TESTOSTERONE INCREASED
1%
DIABETES MELLITUS
1%
MALNUTRITION
1%
URINARY TRACT OBSTRUCTION
1%
BENIGN PROSTATIC HYPERPLASIA
1%
DEEP VEIN THROMBOSIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Delayed Group (Overall)
Early Group
Delayed Group (No Zometa)
Delayed Group (Zometa)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Radiation with Androgen Deprivation Therapy (ADT)Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Androgen Deprivation Therapy (ADT)
2005
Completed Phase 3
~610
Radiation Therapy
2004
Completed Phase 3
~7740
Find a Location
Closest Location:Suburban Hospital· Bethesda, MD· 323 miles
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
576 Previous Clinical Trials
33,502 Total Patients Enrolled
59 Trials studying Prostate Cancer
3,417 Patients Enrolled for Prostate Cancer
Daniel Song, M.D.Principal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Prostate Cancer
24 Patients Enrolled for Prostate Cancer
Phuoc Tran, M.D.Principal InvestigatorJohns Hopkins University
3 Previous Clinical Trials
214 Total Patients Enrolled
1 Trials studying Prostate Cancer
80 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer has a Gleason score of 8 or higher.My cancer has spread to nearby lymph nodes.My cancer has spread to distant parts of my body.I have had major surgery for prostate cancer.I have been cancer-free for 5 years, except for minor skin or superficial bladder cancers.My cancer is at an advanced local stage.My prostate cancer is confirmed and has not spread outside the prostate.I have chosen external beam radiation to treat my prostate cancer.I haven't had a heart attack or stroke in the last year and can safely receive hormone therapy.I have had radiation therapy in the pelvic area before.I have a history of inflammatory bowel disease.My prostate cancer is at an intermediate stage with specific PSA levels and Gleason score.I haven't had chemotherapy for anything other than my current prostate cancer in the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Radiation with Androgen Deprivation Therapy (ADT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.