CyberKnife Radiosurgery for Locally Recurrent Prostate CA

NCT00851916 | Unknown Phase 2

• 1 other identifier: CK Recurrent Prostate SD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Establish pattern of PSA decline

  Post CyberKnife Radiosurgery - 5 year f/up

Secondary Outcomes (1)

• Quality of Life realitive to other commonly used radiation treatment methods for recurrent prostate cancer

  Post CyberKnife Radiosurgery/5 yr. f/up

Study Arms (1)

CyberKnife Radiosurgery

OTHER

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

Radiation: CyberKnife Radiosurgery

Interventions

CyberKnife Radiosurgery RADIATION

CyberKnife Radiosurgery

CyberKnife Radiosurgery

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CyberKnife Centers of San Diego: lead

Study Sites (1)

CybeKnife Centers of San Diego

San Diego, California, 92024, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Donald B Fuller, M.D.

  CyberKnife Centers of San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlyn Tripp

CONTACT

619-230-0400; ctripp@rmgmed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Donald Fuller, M.D.

Study Record Dates

• First Submitted: February 25, 2009
• First Posted: February 26, 2009
• Study Start: February 1, 2009
• Primary Completion: February 1, 2020
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

US (1)