← Back to Search

Hormone Therapy

Radiation for Prostate Cancer

Phase 2
Waitlist Available
Led By Kenneth Pienta, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is testing a new treatment for prostate cancer that involves chemo and radiation. The goal is to find out if it is safe and effective.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy as Assessed by 3-year Prostate-specific Antigen Progression-free Survival Rate
Secondary outcome measures
Safety of the 3 Years Multimodality Therapy Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4 Criteria and the Clavien-Dindo Classification
Time to Prostate-specific Antigen Recurrence

Side effects data

From 2008 Phase 3 trial • 243 Patients • NCT00216125
60%
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
54%
LEUKOCYTES (TOTAL WBC)
51%
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
48%
DYSPNEA (SHORTNESS OF BREATH)
43%
ESOPHAGITIS
38%
NAUSEA
36%
HEMOGLOBIN
35%
HAIR LOSS/ALOPECIA (SCALP OR BODY)
35%
COUGH
33%
PAIN
32%
ANOREXIA
31%
PAIN - OTHER (SPECIFY, __)
29%
PLATELETS
26%
VOMITING
26%
CONSTIPATION
24%
DIARRHEA
19%
MOOD ALTERATION
18%
NEUROPATHY: SENSORY
18%
INFECTION - OTHER (SPECIFY, __)
18%
WEIGHT LOSS
17%
DIZZINESS
15%
FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
15%
PNEUMONITIS/PULMONARY INFILTRATES
15%
HEARTBURN/DYSPEPSIA
13%
INSOMNIA
13%
INFECTION - OTHER
12%
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
12%
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
11%
DEHYDRATION
11%
GASTROINTESTINAL - OTHER (SPECIFY, __)
11%
HYPOTENSION
10%
LYMPHOPENIA
10%
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY
10%
RASH/DESQUAMATION
10%
RASH: DERMATITIS ASSOCIATED WITH RADIATION
8%
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC)
8%
CARDIAC GENERAL - OTHER (SPECIFY, __)
8%
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
7%
ALKALINE PHOSPHATASE
7%
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)
7%
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY)
7%
SWEATING (DIAPHORESIS)
7%
SODIUM, SERUM-LOW (HYPONATREMIA)
7%
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)
6%
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
6%
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA
6%
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
6%
AUDITORY/EAR - OTHER (SPECIFY, __)
6%
SYNCOPE (FAINTING)
6%
METABOLIC/LABORATORY - OTHER (SPECIFY, __)
5%
CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)
5%
HICCOUGHS (HICCUPS, SINGULTUS)
5%
CREATININE
5%
PLEURAL EFFUSION (NON-MALIGNANT)
4%
CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)
4%
HYPERTENSION
4%
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
4%
BLOOD/BONE MARROW - OTHER (SPECIFY, __)
4%
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
4%
THROMBOSIS/THROMBUS/EMBOLISM
4%
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
4%
RIGORS/CHILLS
4%
DERMATOLOGY/SKIN - OTHER (SPECIFY, __)
4%
MUCOSITIS/STOMATITIS (CLINICAL EXAM)
4%
NEUROPATHY: MOTOR
2%
HYPOXIA
2%
COAGULATION - OTHER (SPECIFY, __)
2%
URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)
2%
HEMORRHAGE/BLEEDING - OTHER
2%
EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS
2%
HEMORRHAGE/BLEEDING - OTHER (SPECIFY, __)
2%
PERICARDIAL EFFUSION (NON-MALIGNANT)
2%
BICARBONATE, SERUM-LOW
2%
RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)
2%
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
2%
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
2%
MEMORY IMPAIRMENT
1%
RENAL/GENITOURINARY - OTHER
1%
OCULAR/VISUAL - OTHER (SPECIFY, __)
1%
HOT FLASHES/FLUSHES
1%
CARDIAC ARRHYTHMIA - OTHER (SPECIFY, __)
1%
COLITIS
1%
GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)
1%
URINARY FREQUENCY/URGENCY
1%
CARDIAC ARRHYTHMIA - OTHER
1%
CONSTITUTIONAL SYMPTOMS - OTHER
1%
DYSPHAGIA (DIFFICULTY SWALLOWING)
1%
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
1%
BLOOD/BONE MARROW - OTHER
1%
URIC ACID, SERUM-HIGH (HYPERURICEMIA)
1%
INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME)
1%
VENTRICULAR ARRHYTHMIA
1%
LYMPHATICS - OTHER (SPECIFY, __)
1%
FISTULA, GI
1%
PRURITUS/ITCHING
1%
WATERY EYE (EPIPHORA, TEARING)
1%
SODIUM, SERUM-HIGH (HYPERNATREMIA)
1%
SEIZURE
1%
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
1%
CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
1%
HEMORRHAGE, GI
1%
MUSCULOSKELETAL/SOFT TISSUE - OTHER (SPECIFY, __)
1%
PHOTOSENSITIVITY
1%
PULMONARY FIBROSIS (RADIOGRAPHIC CHANGES)
1%
WEIGHT GAIN
1%
PAIN - OTHER
1%
HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM
1%
PULMONARY/UPPER RESPIRATORY - OTHER
1%
ALKALOSIS (METABOLIC OR RESPIRATORY)
1%
CUSHINGOID APPEARANCE (E.G., MOON FACE, BUFFALO HUMP, CENTRIPETAL OBESITY, CUTANEOUS STRIAE)
1%
SYNDROMES - OTHER (SPECIFY, __)
1%
ARTHRITIS (NON-SEPTIC)
1%
BILIRUBIN (HYPERBILIRUBINEMIA)
1%
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
1%
INFECTION WITH UNKNOWN ANC
1%
INJECTION SITE REACTION/EXTRAVASATION CHANGES
1%
GASTROINTESTINAL - OTHER
1%
GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)
1%
HYPOPIGMENTATION
1%
NAIL CHANGES
100%
80%
60%
40%
20%
0%
Study treatment Arm
Consolidation Docetaxel
Observation Only
Pre-Randomization

Trial Design

1Treatment groups
Experimental Treatment
Group I: chemohormonal and definitive therapy after prostatectomyExperimental Treatment5 Interventions
(1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leuprolide Acetate
2002
Completed Phase 3
~1890
Docetaxel
1995
Completed Phase 4
~5620
Bicalutamide
2003
Completed Phase 3
~5330
Radiation
2003
Completed Phase 3
~1020
Abiraterone Acetate
2015
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,874 Total Patients Enrolled
56 Trials studying Prostate Cancer
3,322 Patients Enrolled for Prostate Cancer
Kenneth Pienta, MDPrincipal InvestigatorSKCCC at Johns Hopkins University
5 Previous Clinical Trials
121 Total Patients Enrolled
3 Trials studying Prostate Cancer
36 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

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

Are there any restrictions on who can participate in this research endeavor?

"This medical trial is searching for 26 willing volunteers between the ages of 18-80 afflicted with prostate cancer. To be eligible, participants need to meet several requirements: being eighteen years or older in age; granting informed consent; registering an Eastern cooperative oncology group (ECOG) performance status ≤2; possessing documented histological evidence of adenocarcinoma of the prostate; undergoing systemic chemo-hormonal therapy and up to 6 cycles of chemotherapy lasting 24 weeks followed by definitive local tumor control with adjuvant radiation treatment, consolidative stereotactic radiation towards oligometastatic lesions over two year period while having T1"

Answered by AI

Are there still opportunities for individuals to enroll in this experiment?

"According to the listing on clinicaltrials.gov, this medical study is not presently accepting new patients. Initially posted in February of 2017 with a status update from March 29th 2022, prospective participants will need to look towards other opportunities for enrolment; at present there are 1770 trials actively recruiting volunteers."

Answered by AI

Have any past research trials included the use of Radiation as a treatment option?

"Currently, 455 clinical trials are researching the area of Radiation with 167 in Phase 3. Although Duarte, California is home to a plethora of these studies, there are 32707 distinct sites across the globe that are undertaking research on this subject."

Answered by AI

To what extent is ionizing radiation hazardous to human health?

"The safety rating for Radiation was assessed by our team as a 2, indicating some clinical evidence of security but no reports of effectiveness."

Answered by AI

How many participants are engaged in this clinical experiment?

"This trial is no longer seeking enrolment. First posted on February 22nd 2017, it was most recently updated on March 29th 2022. For those still looking to participate in a medical study, there are 1,315 open trials for prostate cancer and 455 studies actively recruiting participants for Radiation therapy."

Answered by AI

Do elderly individuals over the age of eighty qualify for enrollment in this investigation?

"This research is open to adults aged 18 and above, up to the maximum age of 80."

Answered by AI

What medical conditions frequently necessitate radiation therapy?

"Radiation is frequently used as a treatment for cancer, but also can be utilized to address other medical issues like anemia, sarcoma and advanced directives."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy
2017. "A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03043807.
~3 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top