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Radiotherapy for Oligometastatic Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01859221
First received: May 13, 2013
Last updated: September 1, 2017
Last verified: September 2017
  Purpose
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.

Condition Intervention
Oligometastatic Prostate Cancer Radiation: Stereotactic radiation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Stereotactic Body Radiotherapy (SBRT) and Stereotactic Hypofractionated Radiotherapy (SHRT) for Oligometastatic Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University of Florida:

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. [ 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 Outcome Measures:
  • Improvement in overall survival of patients with metastatic prostate cancer. [ 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.

  • Treatment failure rates in patients treated with stereotactic radiation for metastatic prostate cancer. [ 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.

  • Quality of life in patients treated with stereotactic radiation for metastatic prostate cancer. [ 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.


Estimated Enrollment: 48
Study Start Date: May 2013
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Radiation: Stereotactic radiation
Stereotactic radiation
Experimental: 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.
Radiation: Stereotactic radiation
Stereotactic radiation

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.

Patients will be asked to complete questionnaires at regular intervals.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01859221

Locations
United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Roi Dagan, MD, MS University of Florida
  More Information

Publications:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01859221     History of Changes
Other Study ID Numbers: UFPTI 1301-OL01
Study First Received: May 13, 2013
Last Updated: September 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Prostate cancer
Oligometastatic prostate cancer
Proton radiation

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 19, 2017