NCT01859221 - Radiotherapy for Oligometastatic Prostate Cancer | Crick

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

39

Conditions

Oligometastatic Prostate Cancer

Interventions

Stereotactic radiationRADIATION

Stereotactic radiation

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 78 months after radiation treatment

Secondary Outcomes

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.

Time frame: 78 months after radiation treatment

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.

Time frame: 78 months after radiation treatment

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.

Time frame: 78 months after radiation treatment