CyberKnife Dose Escalation Prostate Cancer Trial (CK-DESPOT)
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|ClinicalTrials.gov Identifier: NCT03822494|
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : November 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Prostate Adenocarcinoma Prostate Neoplasm||Radiation: CyberKnife SBRT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CyberKnife Dose Escalation for Unfavorable and High-risk Prostate Cancer|
|Actual Study Start Date :||July 12, 2018|
|Estimated Primary Completion Date :||July 12, 2023|
|Estimated Study Completion Date :||July 12, 2028|
|Experimental: Dose Escalated CyberKnife SBRT||
Radiation: CyberKnife SBRT
- Bladder and Rectal Toxicity using NCI common toxicity criteria version 4.0 [ Time Frame: 24 Months ]Genitourinary or Bowel Toxicity as a result of radiation therapy will be reported using
- Biochemical Disease Free Survival [ Time Frame: 24 Months ]Time in months from completion of SBRT to biochemical failure
- Duration of local control [ Time Frame: 24 Months ]time in months from SBRT completion to local failure
- Distant Failure [ Time Frame: 24 Months ]time in months from SBRT completion to distant failure
- Disease Free Survival [ Time Frame: 24 Months ]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.
- Disease Specific Survival [ Time Frame: 24 Months ]time in months from completion of SBRT to death due to prostate cancer, other causes with active malignancy, or complications from treatment.
- Overall Survival [ Time Frame: 5 years ]ime in months from SBRT completion until death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822494
|Contact: Rachelle Lanciano, MDemail@example.com|
|Contact: Michael Good, RNfirstname.lastname@example.org|
|United States, Pennsylvania|
|Crozer Keystone Health System/Philadelphia CyberKnife Center||Recruiting|
|Havertown, Pennsylvania, United States, 19083|
|Contact: Shilecion Cooper, RN 610-446-6850|