Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction in patients with low and intermediate risk prostate cancer.

36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction

CyberKnife Stereotactic Radiosurgery

Robert Meier, MD

Irving Kaplan, MD

Martin Sanda, MD

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

The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.

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

Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution

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.

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.

To determine the rates of local failure, distant failure, disease-free survival, disease-specific survival, and overall survival following CyberKnife treatment in prostate cancer patients. Kaplan Meier estimates for 5-yr and 10-yr are reported.

AUA-SI is a 7-item self-report measure used to assess urinary urgency, frequency, and voiding symptoms with scores ranging from 0 (no symptom) to 5 (symptom occurs almost always).

Total score: 0-7 mild symptoms; 8-19 moderate symptoms; 20-35 severe symptoms

EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal.

Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.

Accuray Incorporated

All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.

Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction

Age, Continuous

Sex: Female, Male

American Indian or Alaska Native

Asian

Black/African American

Hispanic/Latino

Native Hawaiian or Other Pacific Islander

White

Unknown

Race/Ethnicity, Customized

United States

Region of Enrollment

T1b = Tumor incidental histological finding in >5% of tissue resected

T1c = Tumor identified by needle biopsy found in one or both sides, but not palpable

T2a = Tumor involves ½ of one side or less

T2b = Tumor involves >½ of one side but not both sides

Clinical T category of prostate cancer, estimated by investigator at the time of patient screening.

Clinical Stage (Tumor)

Gleason 2 - 6

Gleason 7

The Gleason score is calculated by adding together the two grades of cancer cells that make up the largest areas of the biopsied tissue sample. The Gleason score usually ranges from 6 to 10. Cancer cells that look similar to healthy cells receive a low score. Cancer cells that look less like healthy cells or look more aggressive receive a higher score.

Patients with Gleason scores 2-6 are in the Low Risk Group. Patients with Gleason scores of 7 are in the Intermediate Risk Group.

Total Gleason Score

Prostate Specific Antigen (PSA)

0 = Fully active, able to carry on all pre-disease performance without restriction

1 = Restricted in physically strenuous activity

2 = Capable of all selfcare but unable to carry out any work activities

3 = Capable of only limited selfcare

Unreported

The ECOG Performance Status Scale describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.).

It was developed by the ECOG and published in 1982.

Eastern Cooperative Oncology Group (ECOG) Performance Status

Low: Clinical Stage (CS) T1b-T2a, Gleason 2-6, Prostate Specific Antigen (PSA) ≤ 10 ng/ml

Intermediate: CS T2b, Gleason 2-6, PSA ≤ 10 ng/ml

Intermediate: CS T1b-T2b, and Gleason 2-6, PSA ≤ 20 ng/ml

Intermediate: CS T1b-T2b and Gleason 7, PSA ≤ 10 ng/ml

American Joint Committee on Cancer (AJCC) 6th Edition Risk Group

A limitation of this study is that of the 21 sites originally enrolling eligible patients, only 14 opted to continue beyond year 5. While 189 patients were followed through year 5, only 135 of these consented to continued follow-up. We also note that several patients were due for their 10-year follow-up during Coronavirus Disease (COVID) lockdowns, hampering study activities such as monitoring visits as well as patient compliance with protocol-required visit windows.

Director of Clinical Affairs

Probability of experiencing Acute GI Grade 3+ event(s)

Probability of experiencing Acute GU Grade 3+ event(s)

Probability of experiencing Late GI Grade 3+ events 5 years post treatment

Probability of experiencing Late GU Grade 3+ events 5 years post treatment

Probability of experiencing Late GI Grade 3+ event(s) at 10 years post CK treatment

Probability of experiencing Late GU Grade 3+ event(s) at 10 years post CK treatment

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

Probability of remaining disease-free at 5 years post-CyberKnife treatment

Probability of remaining disease-free at 10 years post-CyberKnife treatment

Biochemical Disease-Free Survival (bDFS)

Probability of remaining free from Local Failure at 5 years post-CyberKnife treatment

Probability of remaining free from Local Failure at 10 years post-CyberKnife treatment

Probability of remaining free from Distant Failure at 5 years post-CyberKnife treatment

Probability of remaining free from Distant Failure at 10 years post-CyberKnife treatment

Probability of remaining free from disease at 5 years post-CyberKnife treatment

Probability of remaining free from disease at 10 years post-CyberKnife treatment

Probability of remaining free from prostate cancer at 5 years post-CyberKnife treatment

Probability of remaining free from prostate cancer at 10 years post-CyberKnife treatment

Probability of Overall survival at 5 years post-CyberKnife treatment

Probability of Overall survival at 10 years post-CyberKnife treatment

Disease Control and Survival Outcomes

Baseline

Last Day of Treatment

1 Week Post Treatment

1 Month Post Treatment

3 Months Post Treatment

6 Months Post Treatment

12 Months Post Treatment

18 Months Post Treatment

24 Months Post Treatment

36 Months Post Treatment

48 Months Post Treatment

60 Months Post Treatment

72 Months Post Treatment

84 Months Post Treatment

96 Months Post Treatment

108 Months Post Treatment

120 Months Post Treatment

AUA questionnaires were completed by patients for milestone follow-up visits, with 306/310 patients completing a baseline questionnaire. All questions needed to be completed in order to calculate the score. Scores obtained per instructions (if possible) and analyzed even if questionnaires were received/dated outside protocol specified visit window.

Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI)

EPIC questionnaires were completed by patients at follow-up visits, with 300/310 patients completing a baseline questionnaire. A minimum number of questions needed to be completed within each domain in order to calculate a domain score. Domain scores obtained per instructions (if possible) and analyzed even if questionnaires were received/dated outside protocol specified visit window.

Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence

Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive

Quality of Life Assessments: EPIC-26 Bowel

Quality of Life Assessments: EPIC-26 Sexual

Overall Study

Single arm study using the Novalis Tx to perform radiosurgery to treat low grade prostate cancer.

Stereotactic Radiosurgery using the Novalis Tx

Jennifer Joiner

Jeremy Legg

Lori A Coleman, MD

P. Brian Volpp, MD, MPH

Kelly D Dewitt, MD

Barry Uhl, MD

Geoffrey Weinstein, MD

Phillip Zentner, MD

The purpose of this trial is to evaluate a short course of very focused (stereotactic) external beam radiation therapy for the treatment of early stage prostate cancer.

The investigators will gather scientific information about the tolerance and side effects this type of radiation. The investigators will then compare these results with those of standard 8 week course of external beam radiation therapy to see if this study treatment is equally or more effective in treating prostate cancer.

Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer

Phase 1 Study of Stereotactic Hypofractionated Radiosurgery of Low Grade Prostate Cancer/Early Stage

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution	NCT00643994	Prostate Cancer Prostatic Cance... Prostate Neopla... Prostatic Neopl... Cancer of the P...	CyberKnife Ster...	18 Years -	Accuray Incorporated
Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer	NCT00969202	Prostate Cancer	Stereotactic Ra...	18 Years - 99 Years	San Diego Radiosurgery
The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study	NCT04075305	Oncology Breast Cancer Prostate Cancer Gynecologic Can... Brain Tumor Brain Cancer Gynecologic Tum... Prostate Tumor Prostate Neopla... Breast Tumor Radiation Toxic... Quality of Life Rectal Cancer Rectal Tumor Rectal Neoplasm... Lung Cancer Lung Tumor Lung Neoplasm Esophageal Canc... Esophagus Cance... Esophageal Tumo... Esophageal Neop... Esophagus Tumor Esophagus Neopl... Pancreatic Canc... Pancreatic Tumo... Pancreatic Neop... Head and Neck C... Head and Neck N... Head and Neck T... Tumor Neoplasms Bladder Cancer Bladder Neoplas... Liver Cancer Liver Neoplasms Liver Metastase... Oligometastases	Radiation thera...	18 Years -	UMC Utrecht
Remimazolam Versus Propofol for General Anesthesia Induction in Patients on Renin-angiotensin System Blockers Undergoing Robot-assisted Laparoscopic Prostatectomy	NCT06093971	Prostate Tumor	remimazolam Propofol	19 Years -	Yonsei University
Stereotactic Body Radiotherapy for Stage I-III Prostate Cancer	NCT02334579	Prostate Cancer Prostatic Cance... Prostate Neopla... Prostatic Neopl... Cancer of the P...	CyberKnife Ster...	18 Years -	Swedish Medical Center
Prostate Conformal Cryotherapy	NCT00877682	Prostate Cancer	Cryoablation	-	M.D. Anderson Cancer Center
CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry	NCT00643617	Prostate Cancer Prostatic Cance... Prostatic Neopl... Prostate Neopla... Cancer of the P...	CyberKnife Ster... CyberKnife Ster...	18 Years -	Accuray Incorporated
Comparison of Two Insertion Technique of I-gel	NCT01826565	Prostate Cancer Prostate Tumor Bladder Cancer Bladder Tumor	Rotational tech...	18 Years - 80 Years	Seoul National University Hospital

Spots Global Cancer Trial Database for prostate tumor