Recruiting
Phase 2

CyberKnife

Sponsor:

CyberKnife Centers of San Diego

Code:

NCT00851916

Conditions

Recurrent Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CyberKnife Radiosurgery

Study Details

Brief summary:

The purpose of this study is to scientifically evaluate the effects (good and bad) of a new type of radiation treatment in patients with locally recurrent prostate cancer after prior radiotherapy. The treatment is known as prostate radiosurgery, and is distinguished from traditional radiotherapy by the application of smaller, more precisely controlled margins around the area targeted for full dose radiation, and far fewer treatments, using a much larger dose per treatment.

This research is being done to see what advantages, if any, prostate radiosurgery may have over other salvage treatment methods, including brachytherapy, cryosurgery, high intensity focused ultrasound (HIFU), hormonal therapy and radical prostatectomy.

Conditions

Recurrent Prostate Cancer

Study ID

NCT00851916

Start date

Feb, 2009

Status verified date

Jul, 2017

Primary completion date

Feb, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically confirmed recurrent adenocarcinoma of the prostate, clinical stage T1 - T3 (AJCC 6th Edition, see Appendix II), NX/N0, M0, following prior prostate radiotherapy.
  • Karnofsky performance status >80.
  • Greater than 5 year life expectancy
  • Greater than 2 years since the original course of radiotherapy.
  • Absence of distant metastases by radiologic or pathologic assessment.
  • Absence of lymph node involvement by radiologic or pathologic assessment.
  • Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:

  • Stage T4 disease (AJCC 6th Edition, see Appendix II).
  • Less than 2 years since the original course of radiotherapy.
  • Lymph node involvement (N1).
  • Evidence of distant metastases (M1).
  • Radical surgery for carcinoma of the prostate
  • Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years.
  • Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
  • History of inflammatory bowel disease
  • Late GI or GU Morbidity > Grade 1 from the prior course of radiotherapy

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: CyberKnife Radiosurgery

Single arm study using CyberKnife radiosurgery to treat recurrent prostate cancer patients that have already received external beam radiotherapy.

Interventions

CyberKnife Radiosurgery

CyberKnife Radiosurgery

Primary outcome measure

  • Establish pattern of PSA decline [ Time Frame: Post CyberKnife Radiosurgery - 5 year f/up ]

Central Contacts and Locations

Central contacts

Carlyn Tripp

619-230-0400ctripp@rmgmed.com

Locations

CybeKnife Centers of San Diego

Recruiting

San Diego, California, United States, 92024

Principal Investigator:

Donald B. Fuller, M.D.

More Information

Sponsor

CyberKnife Centers of San Diego

Last update posted

Jul 21, 2017

Last verified

Jul, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CyberKnife Centers of San Diego on 2017-07-21.