CK-DESPOT: CyberKnife Dose Escalation Prostate Cancer Trial

• Sponsor: Crozer-Keystone Health System (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03822494
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Jul 12, 2018
• Anticipated Primary Completion Date: Jul 12, 2023
• Anticipated Study Completion Date: Jul 12, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Escalated CyberKnife SBRT	Radiation: CyberKnife SBRT; Radiation Therapy

Outcome Measures

Primary Outcome Measures

1. Bladder and Rectal Toxicity using NCI common toxicity criteria version 4.0 [24 Months]

   Genitourinary or Bowel Toxicity as a result of radiation therapy will be reported using

Secondary Outcome Measures

1. Biochemical Disease Free Survival [24 Months]

   Time in months from completion of SBRT to biochemical failure

2. Duration of local control [24 Months]

   time in months from SBRT completion to local failure

3. Distant Failure [24 Months]

   time in months from SBRT completion to distant failure

4. Disease Free Survival [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 [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 [5 years]

   ime in months from SBRT completion until death

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Crozer Keystone Health System/Philadelphia CyberKnife Center	Havertown	Pennsylvania	United States	19083

Sponsors and Collaborators

• Crozer-Keystone Health System

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - May 5, 2018

More Information

Publications

None provided.

• Responsible Party: Rachelle Lanciano M.D., Principal Investigator, Crozer-Keystone Health System
• ClinicalTrials.gov Identifier: NCT03822494
• Other Study ID Numbers: PCK-02
• First Posted: Jan 30, 2019
• Last Update Posted: Apr 21, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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., Principal Investigator, Crozer-Keystone Health System: radiation therapy; Cyberknife; SBRT; Protons
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Apr 21, 2021