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

Gastrointestinal Agents

All Drugs and Chemicals

Herbal and Botanical

Pancrelipase

Pancreatin

Cola

Participants will be robotic surgeons in urologic, gynecologic, colorectal, hepatobiliary, gastric, and thoracic surgery

Surgeons will perform and participants will undergo robotic surgery according to the standard of care. No additional interventions will be performed on participating participants.

Robotic Surgery

Alvin Goh, MD

The purpose of this study is to develop new tools to understand surgeon performance to improve surgical training and participant outcomes after surgery.

Improving Surgeon Performance Measures for Robot-Assisted Surgery

Generalized Robotic Skills Assessment Using Machine Learning-Based Analysis Across Multiple Surgical Specialties

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

For the primary objective, we will capture Automated Performance Metrics/APMs and will determine the association between these and other metrics and surgeon experience, which will be used to construct validation.

APMs that will be used in the study:

Time Metrics

Camera Metrics

Instrument Metrics

System Metrics

Articulation Metrics

Memorial Sloan Kettering Cancer Center

This treatment concentrates large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. CyberKnife Stereotactic Radiosurgery is not investigational and is considered standard of care.

Five treatments given over about one week.

Mary Monahan

The purpose of this study is to find out the effects (good and bad) of highly focused radiation on you and your prostate cancer. The purpose of this evaluation is to see if this treatment causes fewer side effects that other standard treatment approaches, and to evaluate the effect of this treatment on your prostate tumor and your quality of life over time.

Stereotactic Body Radiotherapy for Stage I-III Prostate Cancer

Function-Preserving Stereotactic Body Radiotherapy for Clinical State I-III Prostate Cancer

Measure quality of life after five years following cyberknife stereotactic radiosurgery.

In the low- and intermediate-risk prostate cancer groups, to determine whether study treatment improves patient-reported quality of life outcomes compared to the approach used in a previous multi-center cyberknife stereotactic radiosurgery trial.

In the high-risk group, to estimate rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities following cyberknife stereotactic radiosurgery.

After five years following cyberknife stereotactic radiosurgery, estimate rates of toxicities related to treatment.

Measure disease free survival after five years following cyberknife stereotactic radiosurgery.

Measure overall survival after five years following cyberknife stereotactic radiosurgery.

Swedish Medical Center

38 Gy delivered in 4 fractions of 9.5 Gy per fraction

38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 2 mm around the prostate

CyberKnife Stereotactic Radiosurgery - Low Risk

38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 5mm posterolaterally

CyberKnife Stereotactic Radiosurgery - Intermediate Risk

Donald B Fuller, MD

George Mardirossian, PhD

The purpose of this study is to investigate the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer and to evaluate the effects of this treatment on the quality of life over time.

In this study, CyberKnife radiosurgery will be used to produce dose distributions comparable to those created by High Dose Rate (HDR) brachytherapy treatment, without the use of invasive catheters. The radiosurgery volumes will closely be made to resemble HDR brachytherapy therapeutic volumes with similar dose limitation objectives to adjacent normal tissues.

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 Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry

Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry

To estimate the rates of acute and late Grade 3-5 gastrointestinal and genitourinary toxicities (adverse events \[AE\]) observed in both low-risk and intermediate-risk cohorts 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 survival curves for bDFS were created and the 5-yr and 10-yr percentages are reported.

The Phoenix definition uses a Prostate Specific Antigen (PSA) value exceeding the patients 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.

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

Patients with CS T1b-T2a and Gleason 2-6 and PSA ≤ 10

Low Risk

Patients with 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

Intermediate Risk

Total

Native Hawaiian or Pacific Islander

Tumor Clinical Stage (CS)

The pathologist looking at the biopsy sample will assign one Gleason grade to the most predominant pattern in the biopsy and a second Gleason grade to the second most predominant pattern. The two grades will then be added together to determine the Gleason score. Gleason scores range from 2-10. 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.

Low: CS T1b-T2a, Gleason 2-6, PSA ≤ 10 ng/ml

A limitation of this study is that of the 18 sites originally enrolling eligible patients, only 7 opted to participate in the extension of follow-up through 10 years. However, from these 7 sites, 130 patients, out of the 151 total patients who completed 5-year follow-up, consented to continue follow-up beyond 5 years.

Patients with Clinical Stage (CS) Tumor (T)1b-T2a and Gleason 2-6 and Prostate Specific Antigen (PSA) ≤ 10 ng/ml

Patients with CS T2b and Gleason 2-6 and PSA ≤ 10 ng/ml or CS T1b-T2b and Gleason 2-6 and PSA ≤ 20 ng/ml or Gleason 7 and PSA ≤ 10 ng/ml

Patients with CS T1b-T2a and Gleason 2-6 and PSA ≤ 10 ng/mL

Probability of surviving prostate cancer at 5 years post-CyberKnife treatment

Probability of surviving prostate cancer at 10 years post-CyberKnife treatment

CS T1b-T2a, Gleason Score 2-6, PSA \< or = 10 ng/ml

38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 2 mm around the prostate

CS T2b, Gleason Score 2-6, PSA \< or = 10 ng/ml or CS T1b-T2b, Gleason Score 2-6, PSA \< or = 20 ng/ml or CS T1b-T2b, Gleason Score 7 and PSA \< or = 10 ng/ml

38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 5mm posterolaterally

AUA questionnaires were to be completed by patients for each follow-up visit. All questions need to be completed in order to calculate the score. During follow-up, patients may have withdrawn from the study, did not consent to continue follow-up through 10 years, were lost to follow-up, decided not to complete a questionnaire, or did not fully complete a questionnaire. Scores were calculated on fully completed questionnaires even if received/dated outside protocol specified visit window.

EPIC questionnaires were completed by patients at follow-up visits. 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.

Patients with clinical stage (CS) Tumor (T) 1b-T2a and Gleason 2-6 and Prostate specific Antigen (PSA) ≤ 10 ng/ml

Central Nervous System Depressants

Anesthetics

in Group 3D, an intrafascial nerve-sparing (NS) technique will be performed on the side of the lesion; contralaterally an intra-, inter- or extra-fascial NS technique will be performed. After removal of the prostate, virtual images of the prostate will be projected into the lodge using AI software and will be displayed thanks to the Tile-Pro. The virtual 3D model will allow identifying the extracapsular extension of the tumor lesion, projected at the level of the preserved neurovascular bundle.

A first selective excisional biopsy at the level of the suspected ECE on the NVB will be sent for extemporaneous histological examination. Under 3D AR guidance, a second selective biopsy will then be performed on the NVB at the same level as the first, however involving a larger and thicker layer of tissue. the biopsies will be sent for extemporaneous histological examination. In case of positivity, the entire NVB will be removed

For the no-3D group, the intra-, inter- or extra-fascial NS technique during robotic prostatectomy will be performed according to the clinical indication.

At the end of the demolitive phase a selective biopsu was performed in a cognitive fashion accordin with the information provided by MRI images.

Reconstructive phase was performed according to our previously described total anatomical reconstruction (TAR) technique for both arms.

The operation is performed using the "Da Vinci HD" robotic system which allows the use of laparoscopic instruments, with greater mobility and the possibility of easier and more precise control of movements in three dimensions. Furthermore, the system allows the surgeon a three-dimensional view of the operating field. The surgery is performed under general anesthesia. Six or more trocars are positioned, into which the instruments operated by the robot or directly by the surgical assistants are inserted.

Then a radical prostatectomy is performed.

3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy

Enrico Checcucci, MD

Marco Asioli

Francesco Porpiglia, MD

This is a prospective randomized multicenter study aimed at comparing 3D AI-AR-RARP vs. no 3D, verifying the impact of this new technology on oncological and functional outcomes after the procedure.

Considering that prostate cancer lesions are not identifiable during surgery, except in the case of extensive and advanced tumors, the surgeon does not have a real-time perception of the location of the tumor. The absence of clear spatial visualization can therefore lead to a positive surgical margin, particularly in tumors in the T3 stage (invasion of the prostatic capsule or seminal vesicles).

Our hypothesis is that with the help of AI 3D AR during surgery, positive surgical margins can be avoided, or at least reduced, while preserving the neurovascular bundles, with a consequent improvement not only in postoperative functional outcomes (continence and potency), but also oncological ones (less biochemical disease recovery (BCR), less need for salvage radiotherapy, lower risk of metastasis).

Patients will be randomized using an Excel® macro in 2 group: 3D and no3D, stratifying them by age, PSA, cT, PSA density, prostate volume, lesion volume, extracapsular extension (ECE), seminal vesicle invasion (SVI), biopsy ISUP.

Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention

RIDERS: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention: a Prospective Multicenter Randomized Controlled Trial

Verify the potential application of AI as an alert system during surgery in order to reduce the rate of possible intraoperative complications

Verify oncological outcomes in prostate cancer patients with evidence of bulging or extracapsular disease (ECE or rT3) on preoperative MRI, in terms of positive margin rate (PSM) following surgery

Evaluation of continence recovery rate. Continence was defined as use of 0-1 pads/die. Furthermore 24/h pad test was performed in case of persistence of incontinence to evaluate the different degree of urine losses, and was classified according to ICS definitions.

Evaluation of erection recovery in terms of IIEF-5 (International Index of Erectile Function Questionnaire).

Evaluation of patients' oncological outcomes during the follow up in terms of biochemical recurrence (BCR) and occurrence of local/distant recurrence detected with different imaging techniques during the FU according to clinical indication

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
Improving Surgeon Performance Measures for Robot-Assisted Surgery	NCT06037837	Surgery	Robotic Surgery	18 Years -	Memorial Sloan Kettering Cancer Center
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
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
Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention	NCT06318559	Cancer of Prost...	3D Robot-assist...	40 Years - 99 Years	Fondazione del Piemonte per l'Oncologia

Spots Global Cancer Trial Database for prostate surgery