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Radioisotope
Radium-223 + Radiotherapy for Prostate Cancer (RROPE Trial)
Phase 2
Waitlist Available
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Asymptomatic or symptomatic hormone naïve men with testosterone levels ≥100 ng/dL with previously treated localized prostate cancer who now have rising PSA's and five or fewer bone metastases.
Histologic confirmation of Prostate Adenocarcinoma diagnosis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
RROPE Trial Summary
This trial will test if treating the primary tumor and a few sites of bone-only metastasis with radiation and a systemic drug will reduce the use of hormone therapy, improve quality of life, and improve overall survival compared to a historic cohort receiving intermittent hormone therapy.
Who is the study for?
Men over 18 with hormone-naïve prostate cancer spread to bone in 5 or fewer places, not previously treated with certain hormones or chemotherapy. Must have a life expectancy of at least 2 years, adequate organ function, and agree to use contraception. Excludes those with brain/visceral metastases, more than five bone metastases, low testosterone levels, other cancers within the last three years (except some skin cancers), recent finasteride/dutasteride use.Check my eligibility
What is being tested?
The trial is testing if external beam radiation combined with Radium-223 can reduce the need for androgen deprivation therapy compared to historical data from intermittent ADT treatment. It's an open-label study where all participants receive the same treatment for their primary tumor and limited bone metastasis sites.See study design
What are the potential side effects?
Possible side effects include typical reactions associated with radiation such as fatigue, skin irritation at the site of treatment, nausea; Radium-223 may cause blood cell count changes leading to increased infection risk or bleeding problems.
RROPE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man with prostate cancer, rising PSA levels, and up to 5 bone metastases.
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My prostate cancer has been confirmed through tissue examination.
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I am 18 years old or older.
Select...
I can care for myself but may not be able to do active work.
RROPE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Count of Participants Requiring Androgen Deprivation Therapy (ADT) Use at 15 Months
Secondary outcome measures
Evaluate Overall Surival
Evaluate Time to First Skeletal Related Event (SRE)
Evaluate the PSA Doubling Time
+3 moreSide effects data
From 2008 Phase 3 trial • 243 Patients • NCT0021612560%
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%
COAGULATION - OTHER (SPECIFY, __)
2%
HYPOXIA
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%
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%
RENAL/GENITOURINARY - OTHER
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
RROPE Trial Design
1Treatment groups
Experimental Treatment
Group I: Radium Ra 223 dichloride and radiation, all patientsExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation
2003
Completed Phase 3
~1020
Radium Ra 223 dichloride
FDA approved
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,095 Previous Clinical Trials
1,775,565 Total Patients Enrolled
8 Trials studying Prostate Cancer
5,349 Patients Enrolled for Prostate Cancer
BayerIndustry Sponsor
2,237 Previous Clinical Trials
25,326,958 Total Patients Enrolled
39 Trials studying Prostate Cancer
25,919 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on IV antibiotics for a bacterial or fungal infection.I am a man with more than 5 bone metastases.I haven't taken dutasteride in the last 90 days.I am 18 years old or older.I haven't taken finasteride in the last 30 days.I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.I experience loss of bowel control.I am a man who has received hormone therapy in the last 6 months.My testosterone levels are below 100 ng/dL.My cancer's limited spread was confirmed by scans within the last 3 months.I do not have severe heart failure or severe inflammatory bowel disease.I have taken bicalutamide for less than 30 days and can stop it 5 days before the study starts.I am a man with prostate cancer, rising PSA levels, and up to 5 bone metastases.I had radiotherapy for cancer with hormone therapy over 6 months ago.I had a major heart attack in the last 6 months.I am willing and able to sign the consent form for the trial.I am a man with cancer spread to the brain or internal organs, confirmed by scans.I have liver problems causing jaundice or blood clotting issues, but I can still join this study even if I'm on blood thinners.I had hormone therapy or bicalutamide for prostate cancer but stopped as required before joining.I have been cancer-free for at least 3 years, except for non-melanoma skin cancer or in situ carcinoma.I am a man with prostate cancer that has spread to my lymph nodes, confirmed by tests at least 3 months after my first treatment.I agree to use condoms for 6 months after my last dose if my partner can have children.I do not have a severe lung condition that requires hospital care right now.I have had treatment for spinal cord compression.I took bicalutamide for 30-45 days, 6 months before joining, and stopped it 30 days ago.My prostate cancer has been confirmed through tissue examination.I agree to use condoms for 6 months after my last dose if I haven't had my prostate removed and my partner can have children.My bone marrow is not functioning properly.I can care for myself but may not be able to do active work.I have received chemotherapy for prostate cancer.I have been treated with specific radioactive drugs for bone cancer spread.I am a man scheduled for surgery to remove my prostate.
Research Study Groups:
This trial has the following groups:- Group 1: Radium Ra 223 dichloride and radiation, all patients
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current participant capacity for this research endeavor?
"This clinical trial has concluded its recruitment process. It was initially posted on February 27th 2018 and last updated October 6th 2022. For those seeking alternative trials, 1252 medical studies concerning bone health are actively enrolling patients while 8 radiation-related trials are also open for participation."
Answered by AI
Is this experiment an unprecedented exploration of its kind?
"At present, 8 clinical trials for Radiation across 119 cities and 28 countries are still active. Bayer's trial in 2014 was the first to investigate this area of medicine; it entailed Phase 3 drug approval with 806 participants before completion. Since then, 111 similar studies have been finished."
Answered by AI
Are there any opportunities to join this clinical trial at present?
"The trial, which was initially listed on February 27th 2018 and last edited October 6th 2022 no longer seeks participants. However, clinicaltrials.gov currently lists 1260 other medical studies recruiting patients."
Answered by AI
Are there any analogous investigations utilizing radiation?
"At present, 8 medical research projects are being conducted related to radiation therapy. Three of these studies are in the final clinical trial stage and Hasselt Region Dalarna has been identified as a hub for this type of investigation with 367 locations running such trials."
Answered by AI
What safeguards exist to ensure patients' safety when being exposed to radiation?
"While there is some evidence backing up Radiation's safety, the lack of data on efficacy leads us to assign it a score of 2."
Answered by AI
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