Radiotherapy for Oligometastatic Prostate Cancer

Oligometastatic Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859221
• Other study ID #: UFPTI 1301-OL01
• Secondary ID: IRB201702654
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: September 13, 2022

Study information

• Verified date: September 2022
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 13, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Oligometastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Stereotactic radiation
Stereotactic radiation

Locations

Country	Name	City	State
United States	University of Florida Proton Therapy Institute	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in median progression-free survival in patients with metastatic prostate cancer over historic control rates in hormone receptive and castration resistant subgroups.	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.	78 months after radiation treatment
Secondary	Improvement in overall survival of patients with metastatic prostate cancer.	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.	78 months after radiation treatment
Secondary	Treatment failure rates in patients treated with stereotactic radiation for metastatic prostate cancer.	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.	78 months after radiation treatment
Secondary	Quality of life in patients treated with stereotactic radiation for metastatic prostate cancer.	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.	78 months after radiation treatment