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Radiotherapy for Oligometastatic Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01859221
Recruitment Status : Completed
First Posted : May 21, 2013
Last Update Posted : September 14, 2022
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Description
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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.

Condition or disease Intervention/treatment Phase
Oligometastatic Prostate Cancer Radiation: Stereotactic radiation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
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
Study Start Date : May 2013
Actual Primary Completion Date : September 13, 2022
Actual Study Completion Date : September 13, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859221


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

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01859221    
Other Study ID Numbers: UFPTI 1301-OL01
IRB201702654 ( Other Identifier: University of Florida )
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: September 14, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases