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WithdrawnNCT02206724Updated Apr 20, 2018

Prospective Evaluation of Stereotactic Body Radiotherapy for Metastatic Prostate Cancer

An interventional study of STEREOTACTIC BODY RADIOTHERAPY to the prostate gland in Metastatic Prostate Cancer, sponsored by Sharp HealthCare. Withdrawn at 1 site in United States. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-04-20.

Sponsored by Sharp HealthCare · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Unable to enroll patients
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Metastatic Prostate Cancer

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Keywords

  • Metastatic prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

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Lead sponsor

Sharp HealthCare is the lead sponsor of 40 studies on the registry; 4 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    STEREOTACTIC BODY RADIOTHERAPY

    STEREOTACTIC BODY RADIOTHERAPY to the prostate gland

    Radiation: STEREOTACTIC BODY RADIOTHERAPY to the prostate gland

Interventions

  • RadiationSTEREOTACTIC BODY RADIOTHERAPY to the prostate gland
06

What researchers measure

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

    Time frame: 5 years

Secondary outcomes

  1. Feasibility

    Feasibility in terms of accrual and practical treatment delivery

    Time frame: 3-4 years

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Study locations

1 site
  • Sharp Healthcare
    San Diego, California 92123, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02206724
Lead sponsor
Sharp HealthCare
Responsible party
Sponsor
First posted
Aug 1, 2014
Start date
Jul 16, 2014
Primary completion
Apr 17, 2018
Completion
Apr 17, 2018
Last update
Apr 20, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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