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Phase II Stereotactic Body Radiotherapy (SBRT) and Stereotactic Hypofractionated Radiotherapy (SHRT) for Oligometastatic Prostate Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Oligometastatic Prostate Cancer

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Trial Information

Phase II Stereotactic Body Radiotherapy (SBRT) and Stereotactic Hypofractionated Radiotherapy (SHRT) for Oligometastatic Prostate Cancer


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.

Patients will be asked to complete questionnaires at regular intervals.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Improvement in median progression-free survival in patients with metastatic prostate cancer over historic control rates in hormone receptive and castration resistant subgroups.

Outcome Description:

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.

Outcome Time Frame:

78 months after radiation treatment

Safety Issue:

Yes

Principal Investigator

Roi Dagan, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida

Authority:

United States: Institutional Review Board

Study ID:

UFPTI 1301-OL01

NCT ID:

NCT01859221

Start Date:

May 2013

Completion Date:

January 2020

Related Keywords:

  • Oligometastatic Prostate Cancer
  • Prostate cancer
  • Oligometastatic prostate cancer
  • Proton radiation
  • Prostatic Neoplasms

Name

Location

University of Florida Proton Therapy InstituteJacksonville, Florida  32206