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A Phase II Study of MR-Guided High Dose Rate Brachytherapy Boosts For Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostatic Neoplasms

Thank you

Trial Information

A Phase II Study of MR-Guided High Dose Rate Brachytherapy Boosts For Prostate Cancer


BACKGROUND

Brachytherapy, the placement of a radioactive source close to a tumor, is rapidly becoming
an important modality for patients with prostate cancer because higher and more conformal
doses can be safely delivered compared with external beam radiotherapy.

High dose rate (HDR) temporary implants offer several treatment and research based
advantages over permanent seeds, including exceptionally complex and accurate dosimetry in
reference to anatomic images.

Needle placement in brachytherapy procedures requires detailed image guidance, traditionally
obtained with trans-rectal ultrasound (TRUS). MRI offers a 3D dataset, arbitrary imaging
planes, and unparalleled soft tissue resolution of the anatomy, making it the modality of
choice for imaging the prostate gland.

A real-time MR-guided prostate permanent seed implant technique that utilizes both real-time
MRI and real-time dosimetry has been designed, implemented and reported. Results confirm
that TRUS-guided implants may be improved upon by using MRI. To our knowledge, HDR implants
have not yet been performed under MR guidance in a closed bore magnet.

OBJECTIVES

The primary objective is to determine the quality of prostate HDR brachytherapy implants
performed under MR-guidance.

Quality is defined by the percentage of the planning target volume (PTV) encompassed by a
given percentage of the prescribed dose. In this study an implant will be of "acceptable"
quality if 80% of the PTV is encompassed by the 100% isodose (V100 greater than or equal to
80%), in accordance with RTOG guidelines.

ELIGIBILITY

Pathologically confirmed prostate cancer with the following features:

- Gleason score greater than 6, or greater than T2a, or

- PSA greater than or equal to 10, and no evidence of bone metastases;

Age greater than or equal to 18 years;

ECOG performance status of 0 or 1

DESIGN

The study is designed with a "run-in" pilot phase with the objective of refining the
technique.

The evaluation phase is a two-stage optimal design to evaluate the quality of the implant
with an early look for futility.

This study has the potential to enroll a maximum of 27 patients.

Radiation treatment parameters will be patterned after established guidelines in the
literature such as those reported by the American Brachytherapy Society and the
William-Beaumont Hospital. There will be no attempted dose escalation or attempts to
prescribe the dose to unconventional target volumes in this phase of the project.

Inclusion Criteria


- INCLUSION CRITERIA:

Pathologically confirmed prostate cancer with the following features: Gleason score
greater than 6, or greater than T2a, or PSA greater than or equal to 10, and no evidence
of bone metastases

Age greater than or equal to 18 years

ECOG performance status of 0 or 1

Informed consent: All patients must sign a document of informed consent indicating their
understanding of the investigational nature and risks of the study before any protocol
related studies are performed (this does not include routine laboratory tests or imaging
studies required to establish eligibility).

EXCLUSION CRITERIA:

History of prior pelvic or prostate radiotherapy

TURP within the last 6 months or large TURP defect

Contraindication to implant procedure:

- Bleeding disorder

- Active anticoagulation at the time of implant

- Artificial heart valve

Contraindication to MRI:

- Patients weighing greater than 136 kgs (weight limit for the scanner tables)

- Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable
electronic devices.

Preexisting significant urinary obstructive symptoms as reflected by a high (greater than
18) International Prostate Symptom Score (IPSS)

Pubic arch interference or inadequate access to perineum as determined by preliminary MRI

Cognitively impaired patients who cannot give informed consent

Medically Unfit for Anesthesia as defined by an anesthesiology consultant

Other active malignancy (except for non-melanoma skin cancer or malignancy which was
treated with curative intent at least 3 years ago with no further evidence of recurrent
disease.)

Other urinary or medical conditions deemed by the PI or associates to make the patient
ineligible for high dose rate brachytherapy and EBRT.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Kevin A Camphausen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

020207

NCT ID:

NCT00039624

Start Date:

May 2002

Completion Date:

June 2010

Related Keywords:

  • Prostatic Neoplasms
  • Radiation Therapy
  • Prostate Cancer
  • MRI
  • Brachytherapy
  • Phase II
  • Neoplasms
  • Prostatic Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892