COMPLETEDResults postedNA

CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution

The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.

Sponsor

Accuray Incorporated

Enrollment

379 participants

Sites

23 locations

Start Date

December 2007

Completion

January 2021

Prostate CancerProstatic CancerProstate NeoplasmsProstatic NeoplasmsCancer of the Prostate

Enrollment & Timeline

Completed

Target N

379

participants

Sites

locations

Duration

13.1 years

total trial span

Rate

pts/month needed

At 23 sites, each site needs to enroll approximately 0.1 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

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Primary Outcomes

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Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Multicenter Trial of Stereotactic Body Radiation Therapy for Low- and Intermediate-Risk Prostate Cancer: Survival and Toxicity Endpoints.

Meier Robert M, Bloch Daniel A, Cotrutz Cristian et al.International journal of radiation oncology, biology, physics2019

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

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Fetching protocol from ClinicalTrials.gov…

COMPLETEDResults postedNA

CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution

The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.

Sponsor

Accuray Incorporated

Enrollment

379 participants

Sites

23 locations

Start Date

December 2007

Completion

January 2021

Prostate CancerProstatic CancerProstate NeoplasmsProstatic NeoplasmsCancer of the Prostate

Enrollment & Timeline

Completed

Target N

379

participants

Sites

locations

Duration

13.1 years

total trial span

Rate

pts/month needed

At 23 sites, each site needs to enroll approximately 0.1 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Multicenter Trial of Stereotactic Body Radiation Therapy for Low- and Intermediate-Risk Prostate Cancer: Survival and Toxicity Endpoints.

Meier Robert M, Bloch Daniel A, Cotrutz Cristian et al.International journal of radiation oncology, biology, physics2019

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity

Primary Safety Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.

To estimate the rates of acute and late Grade 3-5 gastrointestinal and genitourinary toxicities (adverse events \[AE\]) observed during the 5 years following CyberKnife (CK) treatment for prostate cancer. Kaplan Meier estimates for 5-yr and 10-yr are reported. Adverse events occurring within 3 months of treatment were categorized as acute toxicities, and those developing after 3 months were considered late toxicities. The rates were determined using the first Grade 3 or higher adverse event per patient, reported as possibly, probably, or definitely related to CK treatment. The Common Toxicity Criteria for Adverse Events (CTCAE) Version 3.0 was used to determine the Grade or severity of adverse events in this study, with Grade 3 being severe or medically significant but not immediately life-threatening, Grade 4 being life-threatening and Grade 5 being death related to the adverse event.

Biochemical Disease-Free Survival (bDFS)

Primary Efficacy Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.

To determine the rate of biochemical Disease-Free Survival (bDFS), using the Phoenix definition, following CyberKnife treatment. Kaplan Meier estimates for 5-yr and 10-yr are reported. The Phoenix definition uses a Prostate Specific Antigen (PSA) value exceeding the patient's lowest PSA value (nadir) + 2 ng/mL as an indicator of disease recurrence. The percentage of patients who did not have such a PSA rise or receive any interventional therapy to treat prostate cancer are reported below.

Eligibility

Min Age

18 Years

Sex

male

Healthy Volunteers

View full criteria

Inclusion Criteria:

* Patient must be at least 18 years of age
* Histologically proven prostate adenocarcinoma
* Patients belonging in one of the following risk groups:

Low: Clinical Stage (CS) T1b-T2a and Gleason 2-6 and Prostate Specific Antigen (PSA) ≤ 10, or Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10 or CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml or Gleason 7 and PSA ≤ 10 ng/ml

* Prostate volume: ≤ 100 cc
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

* Prior prostatectomy or cryotherapy of the prostate
* Prior radiotherapy to the prostate or lower pelvis
* Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
* Chemotherapy for a malignancy in the last 5 years
* History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.
* Hormone ablation for two months prior to enrollment, or during treatment.

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CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (23)