NCT03822494

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
27mo left

Started Jul 2018

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jul 2018Jul 2028

Study Start

First participant enrolled

July 12, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2023

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2028

Expected
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

4.9 years

First QC Date

January 28, 2019

Last Update Submit

February 19, 2025

Conditions

Prostate CancerProstate AdenocarcinomaProstate Neoplasm

Keywords

radiation therapyCyberknifeSBRTProtons

Outcome Measures

Primary Outcomes (1)

  • Bladder and Rectal Toxicity using NCI common toxicity criteria version 4.0

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

    24 Months

Secondary Outcomes (6)

  • Biochemical Disease Free Survival

    24 Months

  • Duration of local control

    24 Months

  • Distant Failure

    24 Months

  • Disease Free Survival

    24 Months

  • Disease Specific Survival

    24 Months

  • +1 more secondary outcomes

Study Arms (1)

Dose Escalated CyberKnife SBRT

EXPERIMENTAL

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.

Radiation: CyberKnife SBRT

Interventions

CyberKnife SBRTRADIATION

Radiation Therapy

Dose Escalated CyberKnife SBRT

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsBiological males with prostate cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philadelphia CyberKnife

Philadelphia, Pennsylvania, 19083, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Rachelle Lanciano, MD

    Philadelphia CyberKnife -Crozer Health

    STUDY CHAIR

  • Rachelle Lanciano, MD

    Philadelphia CyberKnife -Crozer Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 28, 2019

First Posted

January 30, 2019

Study Start

July 12, 2018

Primary Completion

June 21, 2023

Study Completion (Estimated)

July 12, 2028

Last Updated

February 21, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)