RAdium-223 and SABR Versus SABR for Oligometastatic Prostate Cancers (RAVENS)
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|ClinicalTrials.gov Identifier: NCT04037358|
Recruitment Status : Active, not recruiting
First Posted : July 30, 2019
Last Update Posted : March 20, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Radium-223 Radiation: stereotactic ablative radiotherapy (SABR)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||RAdium-223 and SABR Versus SABR (Stereotactic Ablative Radiotherapy)|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Randomized Trial of RAdium-223 and SABR Versus SABR for oligomEtastatic Prostate caNcerS (RAVENS)|
|Actual Study Start Date :||August 9, 2019|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2025|
Experimental: Radium-223 and SABR
First radium-223 infusion will be within two weeks of SABR
Radium-223 plus SABR will be within two weeks.
Radiation: stereotactic ablative radiotherapy (SABR)
SABR 1-5 fractions
Active Comparator: SABR
SABR(1-5 fractions) will be administered for all men
Radiation: stereotactic ablative radiotherapy (SABR)
SABR 1-5 fractions
- Progression-free survival [ Time Frame: 12 months ]Time to progression in men who have oligometastatic prostate cancer after therapy. Progression is defined by PCWG2 criteria as follows: >=25% increase in PSA from nadir (and by >=2ng/mL), and/or clinical/radiographic progression (clinical progression = symptomatic progression, worsening of disease-related symptoms or new cancer-related complications; radiographic progression on CT scan defined by RECIST 1.1 criteria: >=20% enlargement in sum diameter of soft-tissue target lesions; or on bone scan >=1 new bone lesions), initiation of ADT or death due to any cause, whichever occurs first.
- Toxicity as assessed by number of participants who experience adverse events [ Time Frame: 12 months ]Number of participants who receive at least one fraction of SABR and Radium-223 who experience adverse events as defined by CTCAE v4.0 after first treatment of SABR and Radium-223.
- Local control at 12 months [ Time Frame: 12 months ]Time from starting treatment until local relapse is documented
- Time to locoregional progression [ Time Frame: 12 months ]Time from starting treatment until local and/or regional relapse is documented
- Time to distant progression [ Time Frame: 12 months ]Time from starting treatment until distant relapse is documented
- Time to new metastasis [ Time Frame: 12 months ]time from starting treatment to the time of a new documented tumor metastasis by CT and/or bone scan. Subjects who do not progress will be censored at the time of the last contact.
- ADT-free survival [ Time Frame: 12 months ]Time from randomization until initiation of androgen-deprivation therapy (ADT).
- Quality of Life as assessed by Pain Severity and Pain Interference using the Brief Pain Inventory [ Time Frame: 12 months ]The brief pain inventory assesses the severity of pain, location of pain, amount of pain over the last 24 hours, and impact of pain on daily functions. Scores for the 4 pain severity items and 7 pain interference items range from 0-10, where 10 is the worst pain or pain that completely interferes with described activity and 0 is the least pain or does not interfere with described activity. The mean of these scores is used to measure pain severity and pain interference.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 100 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Gender Based Eligibility:||Yes|
|Accepts Healthy Volunteers:||No|
- Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone or soft tissue (with at least one bone metastasis) develop within the past 6-months that are ≤ 5.0 cm or <250 cm3
- Patient must have had their primary tumor treated with surgery and/or radiation.
- Histologic confirmation of malignancy (primary or metastatic tumor).
- PSADT <15 months. PSA doubling time (PSADT) will be calculated using as many PSA values that are available from time of relapse (PSA > 0.2). To calculate PSADT, the Memorial Sloan Kettering Cancer Center Prostate Cancer Prediction Tool will be used. It can be found at the following web site: https://www.mskcc.org/nomograms/prostate/psa-doubling-time.
- Patient may have had prior systemic therapy and/or ADT associated with treatment of their primary prostate cancer. Patient may have had ADT associated with salvage radiation therapy (to the primary prostate cancer or pelvis is allowed).
- PSA > 0.5 but <50.
- Testosterone > 125 ng/dL.
- Patient must be ≥ 18 years of age.
- Patient must have a life expectancy ≥ 12 months.
- Patient must have an ECOG performance status ≤ 2.
- Patient must have normal organ and marrow function as defined as:
Before the first administration of Xofigo, the absolute neutrophil count (ANC) should be ≥ 1.5 x 109/L, the platelet count ≥ 100 x 109/L and hemoglobin ≥ 10 g/dL.
* Patient must have the ability to understand and the willingness to sign a written informed consent document.
- No more than 3 years of ADT is allowed, with the most recent ADT treatment having occurred greater than 6 months prior to enrollment.
- PSMA-PET/MRI or PSMA-PET/CT scan within the past 6 months with results that demonstrate more disease lesions than baseline CT/Bone Scan
- Castration-resistant prostate cancer (CRPC).
- Spinal cord compression or impending spinal cord compression.
- Suspected pulmonary and/or liver metastases (greater >10 mm in largest axis).
- Patient receiving any other investigational agents.
- Patient receiving abiraterone and prednisone.
- Patient is participating in a concurrent treatment protocol.
- Serum creatinine > 3 times the upper limit of normal.
- Total bilirubin > 3 times the upper limit of normal.
- Liver Transaminases > 5-times the upper limit of normal.
- Unable to lie flat during or tolerate PET/MRI, PET/CT or SBRT.
- Prior salvage treatment to the primary prostate cancer or pelvis is allowed.
- Refusal to sign informed consent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037358
|United States, Maryland|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Phuoc Tran, M.D., Ph.D.||Johns Hopkins SKCCC|
|Responsible Party:||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Other Study ID Numbers:||
IRB00188450 ( Other Identifier: JHM IRB )
|First Posted:||July 30, 2019 Key Record Dates|
|Last Update Posted:||March 20, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Male Urogenital Diseases