Phase II Stereotactic Body Radiotherapy (SBRT) and Stereotactic Hypofractionated Radiotherapy (SHRT) for Oligometastatic Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Florida
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Improvement in median progression-free survival in patients with metastatic prostate cancer over historic control rates in hormone receptive and castration resistant subgroups.
Study Overview
Brief Summary
The purpose of this phase II study is to evaluate the outcomes of patients treated with an investigational radiation regimen using stereotactic radiotherapy for oligometastatic prostate cancer and to establish efficacy (producing a desired result or effect) and safety in this setting.
Detailed Description
This study will serve as a component of a larger program investigating the benefits of stereotactic radiotherapy in patients with metastatic disease.
This particular study will serve as a benchmark analysis.
All patients will receive stereotactic radiotherapy directed at metastatic tumors.
If primary prostate cancer is active and has not previously been treated with radiation therapy, conventional radiation therapy (6-8 weeks of daily treatment) may be recommended. The metastatic tumor will be treated at the same time.
Hormone therapy will be recommended for all patients.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with metastatic cancer of the prostate,
- •Patients may have received prior surgery,
- •Prior radiation therapy, androgen deprivation therapy (ADT), immunotherapy, bone metastasis directed therapy, or chemotherapy for prostate cancer.
Exclusion Criteria
- •End-stage heart disease,
- •End-stage liver disease,
- •End-stage renal disease,
- •End stage pulmonary disease
- •Current brain or central nervous system metastasis.
Arms & Interventions
Castration Resistant
There are two different prognostic categories, hormones receptive and castration resistant, that have differing historical disease progression rates. We have therefore stratified the trial so that we can independently monitor the hypothesized improvement provided by radiation therapy in these two groups. Both groups will receive the same radiation modality which is interventional stereotactic radiation with two possible schedules of SBRT and SHRT.
Intervention: Stereotactic radiation (Radiation)
Hormone Receptive
There are two different prognostic categories, hormones receptive and castration resistant, that have differing historical disease progression rates. We have therefore stratified the trial so that we can independently monitor the hypothesized improvement provided by radiation therapy in these two groups. Both groups will receive the same radiation modality which is interventional stereotactic radiation with two possible schedules of SBRT and SHRT.
Intervention: Stereotactic radiation (Radiation)
Outcomes
Primary Outcomes
Improvement in median progression-free survival in patients with metastatic prostate cancer over historic control rates in hormone receptive and castration resistant subgroups.
Time Frame: 78 months after radiation treatment
Over the 78 month period, any occurrence of toxicity and/or treatment failure will be monitored via regular patient follow-up interviews. The cumulative rate at 78 months is analytic outcome of interest for each type of secondary outcome.
Secondary Outcomes
- Treatment failure rates in patients treated with stereotactic radiation for metastatic prostate cancer.(78 months after radiation treatment)
- Quality of life in patients treated with stereotactic radiation for metastatic prostate cancer.(78 months after radiation treatment)
- Improvement in overall survival of patients with metastatic prostate cancer.(78 months after radiation treatment)