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CyberKnife Dose Escalation Prostate Cancer Trial (CK-DESPOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03822494
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
Rachelle Lanciano M.D., Crozer-Keystone Health System

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Prostate Adenocarcinoma Prostate Neoplasm Radiation: CyberKnife SBRT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Dose Escalated CyberKnife SBRT Radiation: CyberKnife SBRT
Radiation Therapy




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Biochemical Disease Free Survival [ Time Frame: 24 Months ]
    Time in months from completion of SBRT to biochemical failure

  2. Duration of local control [ Time Frame: 24 Months ]
    time in months from SBRT completion to local failure

  3. Distant Failure [ Time Frame: 24 Months ]
    time in months from SBRT completion to distant failure

  4. 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.

  5. 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.

  6. Overall Survival [ Time Frame: 5 years ]
    ime in months from SBRT completion until death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Biological males with prostate cancer
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Rachelle Lanciano, MD 610-446-6850 rachelle.lanciano@crozer.org
Contact: Michael Good, RN 610-446-6850 mgood@allianceoncology.com

Locations
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United States, Pennsylvania
Crozer Keystone Health System/Philadelphia CyberKnife Center Recruiting
Havertown, Pennsylvania, United States, 19083
Contact: Shilecion Cooper, RN    610-446-6850      
Sponsors and Collaborators
Crozer-Keystone Health System
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Responsible Party: Rachelle Lanciano M.D., Principal Investigator, Crozer-Keystone Health System
ClinicalTrials.gov Identifier: NCT03822494    
Other Study ID Numbers: PCK-02
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Rachelle Lanciano M.D., Crozer-Keystone Health System:
radiation therapy
Cyberknife
SBRT
Protons
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases