Skip to main content
OpenTrials
Completed

NCT Number: NCT01859221

Radiotherapy for Oligometastatic Prostate Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oligometastatic Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stereotactic Radiation

Radiation

Stereotactic radiation

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
May 21, 2013
Registry last updated
Sep 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.