CyberKnife Dose Escalation Prostate Cancer Trial

NCT ID: NCT03822494

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-12
• Study Completion Date: 2028-07-12

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.

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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma; Prostate Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalated CyberKnife SBRT

DE-SBRT will be delivered using the CyberKnife robotic radiosurgery system. Patients will be treated with five SBRT treatments (8 Gy per fraction to the PTV, and 9-10 Gy per fraction to any nodules identified on endorectal MRI) over 7-10 days.

Group Type: EXPERIMENTAL

CyberKnife SBRT

Intervention Type: RADIATION

Radiation Therapy

Interventions

CyberKnife SBRT

Radiation Therapy

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Crozer-Keystone Health System

OTHER

Sponsor Role: lead

Responsible Party

Rachelle Lanciano M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachelle Lanciano, MD

Role: STUDY_CHAIR

Philadelphia CyberKnife -Crozer Health

Rachelle Lanciano, MD

Role: PRINCIPAL_INVESTIGATOR

Philadelphia CyberKnife -Crozer Health

Locations

Philadelphia CyberKnife

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

PCK-02

Identifier Type: -

Identifier Source: org_study_id