Radiotherapy for Oligometastatic Prostate Cancer

Not Applicable

Completed

• Conditions: Oligometastatic Prostate Cancer
• Interventions: Radiation: Stereotactic radiation

• Registration Number: NCT01859221
• Lead Sponsor: University of Florida

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-17
• Study First Posted: 2013-05-21
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-12
• Primary Completion: 2022-09-13
• Study Completion: 2022-09-13
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 39

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hormone Receptive	Stereotactic radiation	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.
Castration Resistant	Stereotactic radiation	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.

Primary Outcome Measures

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

Name	Time	Method
Treatment failure rates in patients treated with stereotactic radiation for metastatic prostate cancer.	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.	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.
Improvement in overall survival of patients with metastatic prostate cancer.	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.

Trial Locations

Locations (1)

University of Florida Proton Therapy Institute; 🇺🇸 Jacksonville, Florida, United States