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VIRTUAL HDR CYBERKNIFE RADIOSURGERY FOR LOCALLY RECURRENT PROSTATIC CARCINOMA: A PHASE II STUDY


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Recurrent Prostate Cancer

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Trial Information

VIRTUAL HDR CYBERKNIFE RADIOSURGERY FOR LOCALLY RECURRENT PROSTATIC CARCINOMA: A PHASE II STUDY


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Establish pattern of PSA decline

Outcome Time Frame:

Post CyberKnife Radiosurgery - 5 year f/up

Safety Issue:

No

Principal Investigator

Donald B Fuller, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

CyberKnife Centers of San Diego

Authority:

United States: Institutional Review Board

Study ID:

CK Recurrent Prostate SD

NCT ID:

NCT00851916

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Recurrent Prostate Cancer
  • Prostatic Neoplasms

Name

Location

CybeKnife Centers of San DiegoSan Diego, California  92024