Prostate Cancer
Conditions
Keywords
Androgen Deprivation Therapy, Ultra-Hypofractionated SBRT, 16-1686
Brief summary
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.
Interventions
DRUGDegarelix
Degarelix monthly for 6 months
RADIATIONstereotactic body radiosurgery (SBRT)
SBRT 8 Gy x 5
Sponsors
Ferring Pharmaceuticals
University of Texas Southwestern Medical Center
University of Michigan
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Eligible patients with intermediate risk disease will be randomized to ADT with SBRT versus SBRT alone. PSA and testosterone testing every 6 months, Biopsy 24-30 months after SBRT
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With a Positive Biopsy | 2 years | compare 2-year biopsy positivity rate of intermediate risk prostate cancer patients treated with SBRT + short course ADT versus SBRT alone. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Degarelix in Conjunction With Stereotactic Body Radiosurgery Degarelix monthly for 6 months SBRT 8 Gy x 5
Degarelix: Degarelix monthly for 6 months
stereotactic body radiosurgery (SBRT): SBRT 8 Gy x 5 | 27 |
| Stereotactic Body Radiosurgery (SBRT) SBRT 8 Gy x 5
stereotactic body radiosurgery (SBRT): SBRT 8 Gy x 5 | 29 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
Baseline characteristics
| Characteristic | Degarelix in Conjunction With Stereotactic Body Radiosurgery | Total | Stereotactic Body Radiosurgery (SBRT) |
|---|---|---|---|
| Age, Continuous | 68 years | 68 years | 70 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 50 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 12 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 19 Participants | 38 Participants | 19 Participants |
| Region of Enrollment United States | 27 Participants | 56 Participants | 29 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 27 Participants | 56 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 27 | 0 / 29 |
| other Total, other adverse events | 2 / 27 | 0 / 29 |
| serious Total, serious adverse events | 1 / 27 | 0 / 29 |
Outcome results
Primary
Number of Patients With a Positive Biopsy
compare 2-year biopsy positivity rate of intermediate risk prostate cancer patients treated with SBRT + short course ADT versus SBRT alone.
Time frame: 2 years
Population: N/A - data were not collected