NCT02206724

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2018

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

3.8 years

First QC Date

July 30, 2014

Last Update Submit

April 18, 2018

Conditions

Metastatic Prostate Cancer

Keywords

Metastatic prostate cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Feasibility

    3-4 years

Study Arms (1)

STEREOTACTIC BODY RADIOTHERAPY

EXPERIMENTAL

STEREOTACTIC BODY RADIOTHERAPY to the prostate gland

Radiation: STEREOTACTIC BODY RADIOTHERAPY to the prostate gland

Interventions

STEREOTACTIC BODY RADIOTHERAPY to the prostate glandRADIATION
STEREOTACTIC BODY RADIOTHERAPY

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sharp Healthcare

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2014

First Posted

August 1, 2014

Study Start

July 16, 2014

Primary Completion

April 17, 2018

Study Completion

April 17, 2018

Last Updated

April 20, 2018

Record last verified: 2018-04

Locations

US(1)