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Hormone Therapy

Radiation + Hormone Therapy for Prostate Cancer

Phase 1 & 2
Waitlist Available
Led By Phuoc Tran, 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
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

Study Summary

This trial is testing if adding radiation to hormone therapy improves outcomes for prostate cancer patients.

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 below
Select...
My prostate cancer is confirmed and has not spread outside the prostate.
Select...
I have chosen external beam radiation to treat my prostate cancer.
Select...
My prostate cancer is at an intermediate stage with specific PSA levels and Gleason score.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 2, 3, 6 12, 18. 24, 30, 36 mont, 4 year and 5 year follow-up points after treatment has been completed for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biochemical failure free-rate
Secondary outcome measures
Biomarker Studies
Dose Volume/ Imaging Data Assessments
Gastrointestinal (GI) and Genitourinary (GU toxicity) assessment
+1 more

Side effects data

From 2012 Phase 3 trial • 522 Patients • NCT00242567
23%
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%
HOT FLUSH
9%
OEDEMA PERIPHERAL
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%
INFLUENZA LIKE ILLNESS
5%
PAIN
5%
MUSCULAR WEAKNESS
5%
ABDOMINAL PAIN
5%
ASTHENIA
5%
NOCTURIA
5%
LOWER RESPIRATORY TRACT INFECTION
4%
WEIGHT INCREASED
4%
HAEMATURIA
4%
HYPERTENSION
4%
HYPOCALCAEMIA
4%
SKIN LACERATION
4%
METASTATIC PAIN
4%
THROMBOCYTOPENIA
3%
PROSTATE CANCER METASTATIC
3%
MUSCULOSKELETAL STIFFNESS
3%
MUSCULOSKELETAL DISCOMFORT
3%
PARAESTHESIA
3%
POLLAKIURIA
3%
PELVIC PAIN
3%
NECK PAIN
3%
HEADACHE
3%
URINARY RETENTION
3%
DYSPEPSIA
3%
PYREXIA
2%
DEATH
2%
CEREBRAL HAEMORRHAGE
2%
LYMPHADENOPATHY
2%
METASTASES TO BONE
2%
DEHYDRATION
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%
CHOLELITHIASIS
1%
METASTASES TO CENTRAL NERVOUS SYSTEM
1%
RENAL IMPAIRMENT
1%
RESPIRATORY FAILURE
1%
CEREBRAL INFARCTION
1%
MALIGNANT NEOPLASM PROGRESSION
1%
METASTASES TO LIVER
1%
METASTASES TO LUNG
1%
MYOCARDIAL INFARCTION
1%
CARDIAC FAILURE CONGESTIVE
1%
GASTROENTERITIS
1%
PNEUMONIA
1%
LOBAR PNEUMONIA
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)

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
~530
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
554 Previous Clinical Trials
32,806 Total Patients Enrolled
57 Trials studying Prostate Cancer
3,378 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

Androgen Deprivation Therapy (ADT) (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01517451 — Phase 1 & 2
Prostate Cancer Research Study Groups: Radiation with Androgen Deprivation Therapy (ADT)
Prostate Cancer Clinical Trial 2023: Androgen Deprivation Therapy (ADT) Highlights & Side Effects. Trial Name: NCT01517451 — Phase 1 & 2
Androgen Deprivation Therapy (ADT) (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01517451 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the prerequisites for signing up for this clinical trial?

"The aim of this study is to recruit 105 patients with adenocarcinoma who are between 18-100 years old. In order to participate, patients must have signed a study-specific consent form and have decided to undergo external beam radiation."

Answered by AI

Will this experiment be recruiting new participants soon?

"According to the information available on clinicaltrials.gov, this study is not looking for new patients right now. The listing was created on May 22nd, 2013 and was last edited on October 25th, 2020. Although this study is not recruiting, there are 2005 other trials enrolling patients."

Answered by AI

Can adolescents participate in this kind of research?

"Eligible patients for this study must be over 18 and under 100 years old."

Answered by AI
~6 spots leftby Dec 2024