Stanford APBI Trial

Clinical Trial

Overview

Intraoperative Radiotherapy (IORT) is one of three approaches used for accelerated, partial breast irradiation at Stanford.

Accelerated, partial breast irradiation (APBI) is a potentially important new way to incorporate radiotherapy in the treatment of women with breast cancer.

Currently, women with breast cancer who undergo a lumpectomy  typically have 6 1/2 weeks of radiation to the entire affected breast after surgery.  Accelerated, partial breast irradiation (APBI) changes this approach in two ways. It shortens the treatment time from 6 1/2 weeks to between 1 to 5 days, and reduces the treatment area from the entire breast to the area of the breast immediately around the lumpectomy site. This is the part of the breast where most cancers are likely to recur.

In many ways APBI is to current whole breast radiotherapy what a lumpectomy is to a mastectomy. The goal is to use a less invasive more focused treatment without compromising survival.

APBI has been used in limited trials in several hundred patients over the last 10 years. These trials show that in properly selected breast cancer patients APBI  worked just as well as whole breast radiotherapy. In the initial studies, investigators relied on the placement of many catheters in the breast tissue (interstial brachytherapy). Newer techniques will hopefully provide the same good results but will deliver the radiation in faster and/or more convenient ways. This could increase interest in APBI and allow additional clinical trials that test the safety and effectiveness of the newer approaches. These newer approaches could increase quality of life for many women with breast cancer.

Investigators at Stanford University Medical Center are currently offering an IRB approved clinical trial that uses three new approaches for APBI. These three approaches are:

    Intraoperative Radiotherapy (IORT) - 1 day

    Intracavitary Brachytherapy (MammoSite) - 5 days

    3-D Conformal/External Beam Radiotherapy - 5 days

The Stanford trial is led by Dr. Frederick Dirbas, Assistant Professor of Surgery, and by Dr. Donald Goffinet, Professor of Radiation Oncology. For further information about the trial please contact Janelle Maxwell or Triona Dolphin at (650) 498-7740.

Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Intermediate Risk Prostate Cancer: Feasibility Study

The hypothesis of this feasibility study is that focal treatment with ExAblate MRgFUS has the potential to be a safe and effective non-invasive treatment for low to intermediate risk, organ-confined prostate cancer involving low incidence of morbidity. The study hypothesis will be tested by measuring treatment-related safety and initial effectiveness parameters in the ExAblate MRgFUS treated patients, as described above.

Based on the result of this study, InSightec will initiate a larger study in an effort to approve low risk, organ-confined prostate cancer as an indication for its ExAblate MRgFUS device.

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • device: MRgFUS Treatment

Eligibility


Inclusion Criteria:

   1. Patient of age between 50 to 75 years, inclusive.

   2. Biopsy confirmed adenocarcinoma of the prostate, performed up to 6 months prior to
   scheduled treatment.

   3. Patient with low-intermediate risk, early-stage organ-confined prostate cancer (cT1c
   and cT2a, N0, M0), diagnosed with TRUS guided transperineal biopsy (TPBx) and
   voluntarily chooses MRgFUS as the non-invasive treatment, who may currently be on
   watchful waiting or active surveillance and not in need of imminent radical therapy.

   4. Patient with PSA less than or equal to 10 ng/mL

   5. Gleason score 6 or 7 (no 5 grades), based on TRUS guided Transperineal Mapping Biopsy,
   as defined in the protocol.

   6. Up to two (2) cancerous lesions may be identified in the prostate; each tumor is not
   more than 10 mm in maximal linear dimension; each tumor should comply with the maximal
   7 Gleason score requirement.

   7. Positive TRUS-guided transperineal biopsy (TPBx) cores, detected in a maximum of four
   (4) sectors, (2 for each cancerous focus) out of 16 sectors (or out of 12 sectors in
   prostates with volume <20 cc)

   8. Low grade tumors may or may not be visible by multi-parametric MRI. Thus, in case of
   MRI-visible tumor, tumor should be in capsular contact of less than 5 mm, on axial
   images.

   9. No definite evidence of extracapsular extension or seminal invasion by MRI

10. Patient eligible for epidural anesthesia, and general anesthesia (in case of
   complication, requiring intervention).

11. Patient is willing and able to give consent and attend all study visits as defined in
   the protocol

12. Prostate gland volume should be no greater than 70 cc, volumetrically measured.

Exclusion Criteria:

   1. ASA status > 2

   2. Contraindications to MRI 2.1. Claustrophobia 2.2. Implanted ferromagnetic materials or
   foreign objects 2.3. Known intolerance to the MRI contrast agent (e.g. Gadolinium or
   Magnevist) 2.4. Known contraindication to utilization of MRI contrast agent

   3. Severely abnormal coagulation (INR>1.5)

   4. Patient with unstable cardiac status including:

   4.1. Unstable angina pectoris on medication 4.2. Documented myocardial infarction
   within 40 days prior to enrolment 4.3. Congestive heart failure NYHA class IV 4.4.
   Unstable arrhythmia status, already on anti-arrhythmic drugs

   5. Severe hypertension (diastolic BP > 100 on medication)

   6. Severe cerebrovascular disease (multiple CVA or CVA within 6 months)

   7. History of orchiectomy, PCa-specific chemotherapy, cryotherapy, Photodynamic therapy
   or radical prostatectomy for treatment of prostate cancer; any prior radiation therapy
   to the pelvis for prostate cancer or any other malignancy.

   8. Patient under medications that can affect PSA for the last 3 months prior to MRgFUS
   treatment (Androgen Deprivation Treatment; alpha reductase inhibitors)

   9. Individuals who are not able or willing to tolerate the required prolonged stationary
   supine position during treatment (approximately 3 hrs.)

10. Any rectal pathology, anomaly or previous treatment, which can change acoustic
   properties of rectal wall or prevent safe probe insertion (e.g., fistula, stenosis,
   fibrosis).

11. Any spinal pathology which can prevent safe administration of epidural anesthesia

12. Identified calcification of 2 mm or more in largest diameter neighboring the rectal
   wall (in a distance of less than 5 mm) and interfering with the acoustic beam path.

13. Lower limb musculo-skeletal fixed deformities.

14. Prostate with multiple cystic lesions.

15. Evidence for seminal vesicle/lymph node involvement of cancer.

16. Subjects with distance of the less than 2mm margin between the tumor and the prostate
   capsule

17. Bladder cancer

18. Patient that had TURP procedure before

19. Urethral stricture/bladder neck contracture

20. Patient with baseline symptoms of incontinence defined as urine leak in any of the
   following circumstances:

   20.1. Before the patient can get to the toilet 20.2. When coughing or sneezing 20.3.
   While being asleep 20.4. While being physically active/exercising 20.5. After
   finishing urinating and being dressed 20.6. Leaking for no obvious reason

21. Patient with baseline impotence scoring 17 or below in the IIEF-5 (SHIM) questionnaire

22. Active UTI

23. Prostatitis NIH categories I, II and III

24. Implant near (<1 cm) the prostate

25. Interest in future fertility

26. Current participation in another clinical investigation of a medical device or a drug
   or has participated in such a study within 30 days prior to study enrollment

Ages Eligible for Study

50 Years - 75 Years

Genders Eligible for Study

Male

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Denise Haas
650-736-1252
Not Recruiting

What's New

Stanford’s APBI trial has now been expanded to include women with  ductal carcinoma in situ (DCIS). Please call 650-498-7740 for more information.