Know Cancer

or
forgot password

A Study of Hypofractionated Stereotactic Body Radiation Therapy (SBRT) Using Continuous Real-time Evaluation of Prostate Motion


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

Thank you

Trial Information

A Study of Hypofractionated Stereotactic Body Radiation Therapy (SBRT) Using Continuous Real-time Evaluation of Prostate Motion


Inclusion Criteria:



- 18 years of age or older

- Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180
days of enrollment

- Signed informed consent

- Gleason score ≤ 7

- If Gleason 7 (3+4=7 or 4+3=7) then <50% of biopsy cores must be positive for any
pathologic grade of prostate cancer

- If Gleason score <7 then there is no limit on the percentage of biopsy cores involved
by prostate cancer

- PSA (within 90 days prior to enrollment)

- ≤ 15 ng/ml prior to start of therapy if Gleason ≤ 6 and

- ≤ 10 ng/ml prior to start of therapy if Gleason 7

- No plan to use hormone therapy prior to evidence of biochemical failure(ie: No
neoadjuvant or adjuvant ADT)

- Tumor stage: T1a, T1b, T1c, T2a, T2b

- ECOG Performance Status 0-1

Exclusion Criteria:

- A history of other malignancy diagnosed within the previous 60 months except for
non-melanoma skin cancer.

- Any patients who have received other investigational therapy within the last 60 days

- Individuals that have previously been implanted with permanent Beacon transponders

- Patients that have any prosthetic implants in the pelvic region that contain metal or
conductive materials (e.g., an artificial hip)

- Patients with implanted pacemaker or defibrillators

- Patients who are felt to have body habitus not conducive to tracking with Calypso
beacons

- Positive lymph nodes or metastatic disease from prostate cancer

- Tumor stage: T2c, T3, or T4

- Previous pelvic radiation therapy

- Previous surgery or chemotherapy for prostate cancer

- Previous transuretheral resection of the prostate (TURP) or cryotherapy to the
prostate

- Prior hormone therapy or plans for concurrent or post treatment adjuvant hormonal
therapy or chemotherapy

- Hormone therapy to include LHRH agonist or oral anti-androgen

- Finasteride and Dutasteride use not excluded

- Concomitant antineoplastic therapy (including surgery, cryotherapy, conventionally
fractionated radiation therapy, and chemotherapy) while on this protocol

- History of Crohn's Disease or Ulcerative Colitis

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Evaluate the safety of the proposed hyperfractionation regimen

Outcome Description:

To evaluate the safety of the proposed hyperfractionation regimen of 5 fractions of radiation to treat prostate cancer with guidance of radiation using the Calypso 4D Treatment System (Calypso, and to compare it to that expected from conventional treatment, which would involve 40-42 smaller radiation fractions over 8-9 weeks.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Daniel Hamstra, Ph.D., MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2010.064

NCT ID:

NCT01288534

Start Date:

January 2011

Completion Date:

February 2018

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

University of Michigan Cancer CenterAnn Arbor, Michigan  48109
The Radiological Associates of SacrementoSacremento, California  95815