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Radiation Therapy

Stereotactic radiation for Prostate Cancer

N/A
Waitlist Available
Led By Roi Dagan, MD, MS
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 78 months after radiation treatment
Awards & highlights

Study Summary

This trial is testing a new radiation therapy for prostate cancer that has spread to a few other parts of the body. They want to see if it is effective and safe.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~78 months after radiation treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 78 months after radiation treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement in median progression-free survival in patients with metastatic prostate cancer over historic control rates in hormone receptive and castration resistant subgroups.
Secondary outcome measures
Improvement in overall survival of patients with metastatic prostate cancer.
Quality of life in patients treated with stereotactic radiation for metastatic prostate cancer.
Treatment failure rates in patients treated with stereotactic radiation for metastatic prostate cancer.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Hormone ReceptiveExperimental Treatment1 Intervention
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.
Group II: Castration ResistantExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic radiation
2009
Completed Phase 1
~90

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,339 Previous Clinical Trials
717,316 Total Patients Enrolled
10 Trials studying Prostate Cancer
3,818 Patients Enrolled for Prostate Cancer
Roi Dagan, MD, MSPrincipal InvestigatorUniversity of Florida
4 Previous Clinical Trials
204 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
European Journal of CancerJournal
New Response Evaluation Criteria in Solid Tumours: Revised RECIST Guideline (version 1.1)
Eisenhauer, E.A., P. Therasse, J. Bogaerts, L.H. Schwartz, D. Sargent, R. Ford, J. Dancey, et al.. 2009. “New Response Evaluation Criteria in Solid Tumours: Revised RECIST Guideline (version 1.1)”. European Journal of Cancer. Elsevier BV. doi:10.1016/j.ejca.2008.10.026.
The LancetJournal
Combined Androgen Deprivation Therapy and Radiation Therapy for Locally Advanced Prostate Cancer: A Randomised, Phase 3 Trial
Warde, Padraig, Malcolm Mason, Keyue Ding, Peter Kirkbride, Michael Brundage, Richard Cowan, Mary Gospodarowicz, et al.. 2011. “Combined Androgen Deprivation Therapy and Radiation Therapy for Locally Advanced Prostate Cancer: A Randomised, Phase 3 Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(11)61095-7.
CA: A Cancer Journal for CliniciansJournal
Cancer Statistics, 2012
Siegel, Rebecca, Deepa Naishadham, and Ahmedin Jemal. 2012. “Cancer Statistics, 2012”. CA: A Cancer Journal for Clinicians. Wiley. doi:10.3322/caac.20138.
New England Journal of MedicineJournal
Sipuleucel-t Immunotherapy for Castration-resistant Prostate Cancer
Kantoff, Philip W., Celestia S. Higano, Neal D. Shore, E. Roy Berger, Eric J. Small, David F. Penson, Charles H. Redfern, et al.. 2010. “Sipuleucel-t Immunotherapy for Castration-resistant Prostate Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1001294.
~3 spots leftby Apr 2025
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