Prospective Evaluation of Stereotactic Body Radiotherapy for Metastatic Prostate Cancer

Metastatic Prostate Cancer Clinical Trial

Official title:

PROSPECTIVE EVALUATION OF STEREOTACTIC BODY RADIOTHERAPY FOR METASTATIC PROSTATE CANCER

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02206724
• Other study ID #: 140794
• Status: Withdrawn
• Phase: N/A
• First received: July 30, 2014
• Last updated: April 18, 2018
• Start date: July 16, 2014
• Est. completion date: April 17, 2018

Study information

• Verified date: April 2018
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 17, 2018
• Est. primary completion date: April 17, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• STEREOTACTIC BODY RADIOTHERAPY to the prostate gland

Locations

Country	Name	City	State
United States	Sharp Healthcare	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Sharp HealthCare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility	Feasibility in terms of accrual and practical treatment delivery	3-4 years