Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer

Status:	Recruiting
Conditions:	Prostate Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	3/10/2019
Start Date:	March 28, 2017
End Date:	February 2020
Contact:	Michael Zelefsky, MD
Email:	zelefskm@mskcc.org
Phone:	212-639-6802

Phase III Randomized Trial Comparing Short Course Androgen Deprivation Therapy and Ultra-Hypofractionated SBRT Versus SBRT Alone For Intermediate Prostate Cancer

Stereotactic body radiation therapy (SBRT) is a very precise form of radiation therapy that
allows the physician to deliver more radiation dose in a single session. Because of this, the
number of radiation sessions can be reduced from the typical 45-48 sessions, as in
conventional daily session radiation, to 5 sessions given every other day over a week and a
half. Giving the radiation at a higher dose during each treatment may be more effective in
killing the prostate cancer cells than the standard way of using external radiation therapy
where a small amount of radiation is given over many sessions.

Androgen Deprivation Therapy (ADT) or hormonal therapy is one of the methods to treat
intermediate risk prostate cancer. This therapy works by reducing the level of testosterone
and stopping them from affecting your cancer. The ADT used in this study is known as
Degarelix. Degarelix is an approved medication that reduces the body's production of
testosterone; this medication is usually given to all men with intermediate risk prostate
cancer getting external radiation.

This study is a randomized study to find out whether combining stereotactic (also known as
precision) radiation to the prostate cancer combined with a short course of Degarelix will
result in a greater likelihood of killing the cancer in the prostate compared to stereotactic
radiation therapy given alone. It has been shown that the combination of radiation with
medications that interfere with testosterone production and its effects makes prostate cancer
cells more sensitive to the radiation.

Inclusion Criteria:

- Biopsy proven intermediate risk prostate cancer, which includes patients with any one
of the following variables:

- Gleason 7 disease

- PSA 10-20 ng/ml

- Clinical T2b-T2c disease Note: Patients who only have radiographic evidence of T3
disease (i.e. extracapsular extension, or seminal vesical invasion radiographically)
will not be excluded.

- Serum testosterone ≥ 240 ng/dL determined within 2 months prior to enrollment

- At least 4 weeks must have elapsed from major surgery

- KPS ≥ 80%

- Prostate size as determined on MRI to be < 90 cc. Prostate size can be determined on
CT scan if MRI is not available.

- 18 years of age or older

- IPSS ≤ 20

- Patient must be available for follow-up. After 2 years of follow-up following
post-treatment biopsy, telephone-based follow-up will be acceptable

- Laboratory test findings within 8 weeks of randomization:

- Adequate hepatic function with serum bilirubin ≤ 1.5 times the upper
institutional limits of normal (ULN), ALT and AST ≤ 2.5 x ULN. Patients with a
history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL
with a predominance of indirect bilirubin

- Adequate renal function with serum creatinine ≤ 1.5 x ULN

- Adequate hematologic function with absolute neutrophil counts ≥ 1,500 cell/mm3
and platelets ≥ 100,000 cells/mm3 and hemoglobin value ≥ 9 g/dL (Note: patients
whose anemia has been corrected to a hemoglobin value ≥ 9 g/dL with blood
transfusions are allowed)

Exclusion Criteria:

- CT or MRI evidence of metastatic disease to the bone.

- Patients with one or more positive lymph nodes considered suspicious as determined by
clinical assessment on MRI or CT

- Prior treatment for prostate cancer, including history of chemotherapy, hormonal
therapy within 30 days of enrollment or surgery for prostate cancer (except for prior
TURP or greenlight PVP which would be allowed)

- History of another malignancy within the previous 3 years except for the following:
adequately treated basal cell or squamous cell skin cancer, superficial bladder
cancer, currently in complete remission, or any other cancer that has been in complete
remission for at least 3 years

- Patients with Crohn's disease or ulcerative colitis

We found this trial at

sites

Memorial Sloan Kettering Cancer Center

1275 York Ave
New York, New York 10021

(212) 639-2000