Phase 2
N=54
Stereotactic Body Radiation for Prostate Oligometastases
Prostate Cancer · Oligometastases
Bottom Line
View on ClinicalTrials.gov: NCT02680587 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Progression at 6 Months — 11; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SBRT (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression at 6 Months |
11; 7 | — |
| SECONDARY Time to Local Progression |
5.8; 6 | — |
| SECONDARY Local Control of SBRT Group |
89 | — |
| SECONDARY Toxicity as Assessed by Number of Participants With Adverse Events Grade 3 or Higher |
0; 0; 0; 0 | — |
| SECONDARY Toxicity as Assessed by Number of Participants With Adverse Events Grades 1 or 2 |
11; 30; 3; 15 | — |
| SECONDARY Change in Quality of Life as Assessed by Brief Pain Inventory |
0; 0 | — |
| SECONDARY Change of DCFPyL-PET/MRI Positive Lesions |
— | — |
| SECONDARY Change in Survival of Two Groups as Assessed by PSA Level |
— | — |
| SECONDARY Androgen Deprivation Therapy-free Survival |
0; 0 | — |
Summary
Men with oligometastatic prostate cancer lesions will be randomized (1:2) to observation versus SBRT. The study will NOT be blinded. Within three weeks of the initial treatment planning, SBRT (1-5 fractions) will be administered.
Eligibility Criteria
Inclusion Criteria
- Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone or soft tissue develop within the past 6-months that are ≤ 5.0 cm or 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 >1 but 125 ng/dL.
- Patient must have a life expectancy ≥ 12 months.
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Patient must have normal organ and marrow function as defined as:
Leukocytes >2,000/μL Absolute Neutrophil Count >1,000/μL Platelets >50,000/μL
- Patient must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- No more than 3 years of ADT is allowed, with the most recent ADT treatment having occurred greater than 6 months prior to enrollment.
- DCFPyL-PET/MRI or DCFPyL-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).
- Suspected pulmonary and/or liver metastases (greater >10 mm in largest axis).
- Patient receiving any other investigational agents.
- Patient is participating in a concurrent treatment protocol.
- 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.
- Liver Transaminases > 5-times the upper limit of normal.
- Prior salvage treatment to the primary prostate cancer or pelvis is allowed.
- Refusal to sign informed consent.
Data sourced from ClinicalTrials.gov (NCT02680587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.