RAdium-223 and SABR Versus SABR for Oligometastatic Prostate Cancers (NCT04037358) | Clinical Trial Compass
CompletedPhase 2
RAdium-223 and SABR Versus SABR for Oligometastatic Prostate Cancers
United States64 participantsStarted 2019-08-09
Plain-language summary
This is a Phase II non-blinded randomized study evaluating men with oligometastatic prostate cancer lesions randomized (1:1) to stereotactic ablative radiation therapy (SABR) versus SBAR + Radium-223. We are looking to determine the progression-free survival of men who have oligometastatic prostate cancer with at least one bone metastasis with stereotactic ablative radiation therapy (SABR) versus SABR + Radium-223.
Who can participate
Age range18 Years – 100 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 c…
What they're measuring
1
Progression-free Survival
Timeframe: Up to 24 months
Trial details
NCT IDNCT04037358
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins