Description:
Stereotactic body radiation therapy (SBRT) has been employed in the treatment of prostate
cancer. Multiple single institution experiences suggest high biochemical control rates with
acceptable toxicity in low risk prostate cancer but efficacy data in unfavorable type
prostate cancer is less convincing. CyberKnife-SBRT (CK-SBRT) can be used to escalate
radiation dose delivery to the prostate while sparing normal tissue.
Title
- Brief Title: CyberKnife Dose Escalation Prostate Cancer Trial
- Official Title: CyberKnife Dose Escalation for Unfavorable and High-risk Prostate Cancer
Clinical Trial IDs
- ORG STUDY ID:
PCK-02
- NCT ID:
NCT03822494
Conditions
- Prostate Cancer
- Prostate Adenocarcinoma
- Prostate Neoplasm
Purpose
Stereotactic body radiation therapy (SBRT) has been employed in the treatment of prostate
cancer. Multiple single institution experiences suggest high biochemical control rates with
acceptable toxicity in low risk prostate cancer but efficacy data in unfavorable type
prostate cancer is less convincing. CyberKnife-SBRT (CK-SBRT) can be used to escalate
radiation dose delivery to the prostate while sparing normal tissue.
Detailed Description
The optimal radiation schedule for the curative treatment of prostate cancer remains unknown.
Prostate cancer patients receiving radiation therapy are typically treated 5 days per week
for 8-9 weeks. Recent data suggest that large radiation fraction sizes are radio-biologically
favorable over lower fraction sizes in prostate cancer radiotherapy. The sensitivity of a
tumor or normal tissue to fraction size of radiation can be approximated by the alpha-beta
ratio. It has been suggested that the alpha/beta ratio for prostate cancer is actually as low
as 1.5 implying that the current radiation therapy paradigm for prostate cancer treatment
might be fundamentally flawed, as high fraction sizes would be expected to damage tumor more
readily.
Typical prostate SBRT doses do not appear to have similar efficacy in higher risk prostate
cancer suggesting even higher doses are required. Many techniques including dose escalated
external beam radiation therapy (EBRT), proton therapy (PT) and brachytherapy have been
employed to increase dose to the prostate. Data from the ASCEND-RT trial utilizing low dose
rate brachytherapy boost showed a dramatic 21% improvement in biochemical control at 9 years
favoring brachytherapy boost compared to conventional dose escalated EBRT radiation therapy.
However, no corresponding benefit was identified in overall survival, incidence of bone
metastases or prostate cancer specific mortality while a 3 fold increase in late urinary
toxicity was noted.
SBRT is well tolerated with minimal acute and late side effects. In this protocol, CK-SBRT
will be used to target the microscopic and gross disease in the prostate, seminal vesicles.
An escalated dose of 40 Gy in 5 fractions will be delivered to the entire target volume while
any nodules visible within the prostate gland on endorectal MRI will receive 50 Gy in 5
fractions.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Escalated CyberKnife SBRT | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate diagnosed within 360 days of
enrollment.
- Prostate Specific Antigen (PSA) documented within 90 days prior to registration.
- Clinical staging completed within 90 days of registration.
- No Nodal or Distant Metastases documented on CT or MRI of the pelvis and bone scan.
- Unfavorable Risk Prostate Carcinoma as Described is documented.
- No prior pelvic radiotherapy.
- No prior Trans-urethral resection of the prostate (TURP).
- Prostate volume < 100 cc
- American Urologic Association (AUA) score < 20
- No recent (within 5 years) or concurrent cancers other than non-melanoma skin cancers.
- Patient must have no medical or psychiatric illnesses that would interfere with
treatment or follow-up.
- No implanted hardware adjacent to the prostate that would prohibit appropriate
treatment planning and treatment delivery is allowed.
- Candidate for rectal spacer placement
Exclusion Criteria:
- Other cancer diagnosis other than non-melanoma skin cancer with 5 years
- Prostate size greater than 100cc
- AUA greater than 20
- Implanted hardware impacting imaging
- Metastatic prostate cancer
- Contraindication to hormone therapy
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Bladder and Rectal Toxicity using NCI common toxicity criteria version 4.0 |
Time Frame: | 24 Months |
Safety Issue: | |
Description: | Genitourinary or Bowel Toxicity as a result of radiation therapy will be reported using |
Secondary Outcome Measures
Measure: | Biochemical Disease Free Survival |
Time Frame: | 24 Months |
Safety Issue: | |
Description: | Time in months from completion of SBRT to biochemical failure |
Measure: | Duration of local control |
Time Frame: | 24 Months |
Safety Issue: | |
Description: | time in months from SBRT completion to local failure |
Measure: | Distant Failure |
Time Frame: | 24 Months |
Safety Issue: | |
Description: | time in months from SBRT completion to distant failure |
Measure: | Disease Free Survival |
Time Frame: | 24 Months |
Safety Issue: | |
Description: | time in months from the date that the patient is determined to be free of disease to the date of known disease recurrence for any measure of disease. |
Measure: | Disease Specific Survival |
Time Frame: | 24 Months |
Safety Issue: | |
Description: | time in months from completion of SBRT to death due to prostate cancer, other causes with active malignancy, or complications from treatment. |
Measure: | Overall Survival |
Time Frame: | 5 years |
Safety Issue: | |
Description: | ime in months from SBRT completion until death |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Crozer-Keystone Health System |
Trial Keywords
- radiation therapy
- Cyberknife
- SBRT
- Protons
Last Updated
April 21, 2021