- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03304418
Radium-223 and Radiotherapy in Hormone-Naïve Men With Oligometastatic Prostate Cancer to Bone (RROPE)
A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naïve Men With Oligometastatic Prostate Cancer to Bone
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Utah
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- Subjects who have been previously treated with definitive and/or adjuvant/salvage radiotherapy to the primary site and/or regional lymph nodes with concurrent ADT are allowed if the last hormone therapy delivered > 6 months prior. Subjects who have had more than 30 days and fewer than 45 days of bicalutamide monotherapy for any reason within the 6 months prior to enrollment are eligible for the study, providing they have been off of the drug for at least 30 days prior to enrollment. Subjects who have had fewer than 30 days of bicalutamide are eligible for the study, as long as they discontinue the drug at least 5 days prior to the first study treatment.
- Histologic confirmation of Prostate Adenocarcinoma diagnosis.
- Age ≥ 18 years.
- Life expectancy of at least 2 years.
Acceptable hematology and serum biochemistry screening values:
- White Blood Cell Count (WBC) ≥ 3,000/mm3
- Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
- Platelet (PLT) count ≥ 100,000/mm3
- Hemoglobin (HGB) ≥ 10 g/dl
- Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Creatinine ≤ 1.5 x ULN
- Albumin > 2.5 mg/dL
- Willing and able to comply with the protocol, including follow-up visits and examinations.
- Karnofsky Performance Score >60 or ECOG equivalent.
- Radiographic confirmation of oligometastatic diagnosis via Bone Scan validated by either CT scan or MRI or PET/CT with Fluciclovine within the past 90 days.
- Subjects who have not had surgical removal of their prostate and have a partner of child bearing potential must agree to use condoms beginning at the signing of the ICF until at least 6 months after the last dose of study drug. Because of the potential side effect on spermatogenesis associated with radiation, female partners of childbearing potential must agree to use a highly effective contraceptive method during and for 6 months after completing treatment
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Exclusion Criteria:
- Men with known brain or visceral metastases (except regional lymph nodes as defined by section 5.2.5) defined by CT or MRI Imaging of the abdomen or pelvis.
- Men who have had LHRH agonist or antagonist hormone therapy in the prior six months.
- Men with >5 bony metastases.
- Men with baseline serum Testosterone <100 ng/dL.
- Men with new or progressing lymphadenopathy clearly consistent with prostate metastasis on imaging or proven by pathologic biopsy at any time three months or later following their initial definitive therapy.
- Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 3 years. All patients with in situ carcinoma are eligible for this study (for example, carcinoma in situ of the oral cavity is eligible) except patients with carcinoma of the bladder (including in situ bladder cancer or superficial bladder cancer).
- Use of finasteride within 30 days prior to therapy PSA should not be obtained prior to 30 days after stopping finasteride.
- Use of dutasteride within 90 days prior to therapy. PSA should not be obtained prior to 90 days after stopping dutasteride.
- Previous or concurrent cytotoxic chemotherapy for prostate cancer.
- Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or Radium Ra 223 dichloride) for the treatment of bony metastases.
- Men who will receive radical prostatectomy to the primary site.
- Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Spinal Cord compression will be defined as 360 degree circumferential obliteration of T2 cerebrospinal fluid signal around the spinal cord. Treatment should be completed for spinal cord compression.
Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. (Patients on Coumadin or other blood thinning agents are eligible for this study.)
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
- Cardiac failure New York Heart Association (NYHA) III or IV Crohn's disease or ulcerative colitis.
- Bone marrow dysplasia.
- Fecal incontinence.
- Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Radium Ra 223 dichloride and radiation, all patients
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Radium Ra 223 dichloride will be delivered intravenously at 55 kBq/kg (1.49 mCi)/kg (+/- 10% total dose) for a total of six cycles. 1 cycle= 28 days.
The first cycle will commence at study enrollment, then cycles 2-6 will commence after the completion of radiotherapies at 4 week intervals
Other Names:
All external beam radiations oligometastatic sites will commence after cycle 1 of Radium-223 but prior to cycle 2 of Radium-223. All subjects will receive Stereotactic body or hypofractionated radiation to sites of bone disease seen on imaging studies. Patients will have the primary tumor sites and 5 or fewer sites of bone-only metastasis treated with external beam radiation. Any of the following regimens are considered ablative, acceptable and are biologically equivalent to 60Gy EQD2:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Count of Participants Requiring Androgen Deprivation Therapy (ADT) Use at 15 Months
Time Frame: 15 months
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To determine if 20% of ADT naïve men treated with concurrent EBRT and Radium-223 will not require ADT for progression by 15 months.
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15 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate Overall Surival
Time Frame: 2 years
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Evaluate overall survival at 2 years relative to the SWOG intermittent ADT historic cohort. Endpoint: Patients will be followed for survival for two years after study enrollment |
2 years
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Median Time From Start of Study Therapy to Start of ADT
Time Frame: 2 years
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Determine the hormone-therapy free survival time for men treated with concurrent EBRT and Radium-223 and determine if it is a 30% risk reduction over the SWOG intermittent ADT historic cohort
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2 years
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Mean Expanded Prostate Inventory Composite (EPIC) Scores at End of Treatment
Time Frame: 6 months
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To evaluate health related quality of life (QOL) as scored by the 50 item Expanded Prostate Inventory Composite (EPIC) EPIC urinary, bowel, sexual and hormonal domains. EPIC assesses the disease-specific aspects of prostate cancer and its therapies and comprises four summary domains (Urinary, Bowel, Sexual and Hormonal). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health-related quality of life. |
6 months
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Mean PROMIS-29 Scores at End of Treatment
Time Frame: 6 months
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To evaluate health related quality of life (QOL). The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) will be used to assess general function and well-being. The raw score for each PROMIS instrument is converted to a T-score on a scale of 0-100. For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T score represents more of the concept being measured. For negatively worded concepts like Anxiety, a T score of 60 is one SD worse than average. By comparison, an Anxiety T score of 40 is one SD better than average. However, for positively worded concepts like Physical Function Mobility, a T score of 60 is one SD better than average while a T score of 40 is one SD worse than average. |
6 months
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Evaluate Time to First Skeletal Related Event (SRE)
Time Frame: 2 years
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Documentation of complications associated with bone metastases and may include (but not limited to) fractures, spinal cord compression, bone pain, and hypercalcemia.
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2 years
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Evaluate the PSA Doubling Time
Time Frame: 2 years, assessed at every visit in that time period
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Time elapsed from baseline PSA to double in value.
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2 years, assessed at every visit in that time period
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCI102312
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Stony Brook UniversityThe University of Texas Health Science Center at San AntonioRecruitingMetastatic Cancer | Metastatic Lung Cancer | Metastatic Breast Cancer | Metastasis | Spine Metastases | Metastatic Tumor | Metastatic Tumor of Bone | Metastatic Tumor to the SpineUnited States
Clinical Trials on Radium Ra 223 Dichloride
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University of Southern CaliforniaNational Cancer Institute (NCI)Active, not recruitingCastration-Resistant Prostate Carcinoma | Stage IV Prostate Cancer | Prostate Carcinoma Metastatic in the BoneUnited States
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University of WashingtonBayerRecruitingCastration-Resistant Prostate Carcinoma | Metastatic Prostate Carcinoma | Stage IV Prostate Cancer AJCC v8 | Metastatic Malignant Neoplasm in the Bone | Stage IVA Prostate Cancer AJCC v8 | Stage IVB Prostate Cancer AJCC v8United States
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Sir Mortimer B. Davis - Jewish General HospitalCompleted
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Carolina Research Professionals, LLCAstellas Pharma IncCompletedProstate Carcinoma Metastatic to the BoneUnited States
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BayerWithdrawnProstatic Neoplasms, Castration-Resistant
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University of UtahCompleted
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The Netherlands Cancer InstituteBayerCompletedBone Metastases | Prostate Cancer MetastaticNetherlands
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National Cancer Institute (NCI)RecruitingClear Cell Renal Cell Carcinoma | Stage IV Renal Cell Cancer AJCC v8 | Metastatic Malignant Neoplasm in the Bone | Chromophobe Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | Collecting Duct Carcinoma | Kidney Medullary Carcinoma | Advanced Renal Cell Carcinoma | Unclassified Renal Cell CarcinomaUnited States
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M.D. Anderson Cancer CenterBayer; Prostate Cancer FoundationCompleted
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BayerNo longer availableProstatic NeoplasmsUnited States