Prospective Evaluation of Stereotactic Body Radiotherapy for Metastatic Prostate Cancer

PROSPECTIVE EVALUATION OF STEREOTACTIC BODY RADIOTHERAPY FOR METASTATIC PROSTATE CANCER

The investigators aim to test the safety and feasibility of prostate gland stereotactic body radiotherapy (SBRT) plus best systemic therapy in newly diagnosed metastatic prostate cancer.

Study Overview

• Status: Withdrawn
• Conditions: Metastatic Prostate Cancer
• Intervention / Treatment: Radiation: STEREOTACTIC BODY RADIOTHERAPY to the prostate gland

Detailed Description

The investigators and other investigators have previously documented the safety and efficacy of definitive intent stereotactic body radiotherapy (SBRT) in the treatment of localized prostate cancer.

In the metastatic setting for multiple malignancies, improved survival rates and disease outcomes have been shown with definitive treatment of the primary disease site. This concept of "cytoreductive" surgery or decreasing the primary tumor burden is now considered the standard of care for metastatic colon, ovarian, renal cell, and some breast carcinomas (plus post-surgery irradiation).

With new guidelines and declining rates of PSA screening, the incidence of newly diagnosed metastatic prostate cancer is expected to increase. A recent population-based study has concluded significant improvements in the definitive treatment of the local prostate cancer in the stage IV setting with either radical prostatectomy or conventional prostate radiation treatments/brachytherapy. To our knowledge, one prospective phase II trial is currently accruing patients to best systemic therapy or best systemic therapy (BST) plus definitive treatment with either radical prostatectomy or conventionally fractionated radiation therapy

The investigators hypothesize that the addition of primary disease SBRT to best systemic therapy for newly diagnosed metastatic prostate cancer would be associated with an acceptable safety profile, quality of life, disease progression, and overall survival. The addition of SBRT to best systemic therapy is also expected to be better-received for stage IV patients (with relatively limited prognosis), vs. fully fractionated radiation therapy, brachytherapy, or radical prostatectomy. The above endpoints would initially be tested in a prospective phase II multi-institutional trial and in comparison with historical controls.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Sharp HealthCare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Histologically-confirmed, adenocarcinoma of the prostate
• Clinical Stage T1b - T4, NX-0-1, M1
• Any Gleason score
• PSA<1000
• ECOG Performance Status 0-2
• No prior prostate radiation or other definitive therapy

Exclusion Criteria:

• Prior prostatectomy or cryotherapy of the prostate
• Prior radiotherapy to the prostate or lower pelvis
• Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
• Chemotherapy for a malignancy in the last 5 years
• History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STEREOTACTIC BODY RADIOTHERAPY; STEREOTACTIC BODY RADIOTHERAPY to the prostate gland	Radiation: STEREOTACTIC BODY RADIOTHERAPY to the prostate gland

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation related toxicity	Radiation related toxicity as per history and physical, and 1 or several of Patient questionnaires: SF-12 questionnaire AUA questionnaire EPIC-26 questionnaire SHIM questionnaire Utilization of Sexual Medications/Devices questionnaire	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	Feasibility in terms of accrual and practical treatment delivery	3-4 years

Collaborators and Investigators

• Sponsor: Sharp HealthCare

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2014
• Primary Completion (Actual): April 17, 2018
• Study Completion (Actual): April 17, 2018

Study Registration Dates

• First Submitted: July 30, 2014
• First Submitted That Met QC Criteria: July 31, 2014
• First Posted (Estimate): August 1, 2014

Study Record Updates

• Last Update Posted (Actual): April 20, 2018
• Last Update Submitted That Met QC Criteria: April 18, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Metastatic prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 140794