Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients undergo Magnetic Resonance imaging (MR) guided laser thermal therapy with Visualase Thermal Therapy device.

MR guided laser ablation of prostate cancer

Visualase Thermal Therapy

magnetic resonance imaging

Aytekin Oto

Scott Eggener, MD

This phase II trial studies how well magnetic resonance (MR)-guided laser interstitial thermal therapy works in treating patients with prostate cancer. Laser therapy uses intense, narrow beams of light to cut and destroy tissue and may help treat prostate cancer

PRIMARY OBJECTIVES:

I. To evaluate the oncologic efficacy of laster interstitial thermal therapy (LITT) with primary endpoint of undetectable cancer on magnetic resonance imaging (MRI)-guided biopsy of treatment zone at 3 months following treatment.

SECONDARY OBJECTIVES:

I. To evaluate oncologic efficacy at 12 months following treatment based on biopsy of the treatment zone.

II. To determine treatment-related safety and toxicity. III. To longitudinally assess urinary and sexual function in the year following treatment.

OUTLINE:

Patients undergo MR-guided LITT.

After completion of study treatment, patients are followed up at 1, 3, and 12 months.

MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer

Phase II Evaluation of MR-Guided Laser Induced Interstitial Thermal Therapy (LITT) for Prostate Cancer

The primary study end point was the number of patients with no cancer on MRI guided biopsy of the ablation zone at 3 months.

A systematic 12-core biopsy was performed at 1 year and the number of patients with biopsy cancer was counted.

Treatment-related toxicity measured by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0

International Prostate Symptom Score (IPSS) measures urinary symptoms and continence and it ranged 0 to 35. Lower values are considered better outcome.

Sexual Health Inventory Score in Men (SHIM) measures sexual health and erectile function and it ranged 1 to 25. Lower values are considered better outcome.

National Cancer Institute (NCI)

University of Chicago

Patients undergo MR-guided laser ablation of prostate cancer

Visualase Thermal Therapy: MR guided laser ablation of prostate cancer

magnetic resonance imaging: Undergo MR-guided LITT

Treatment (LITT)

Age, Continuous

Sex: Female, Male

Dr. Aytekin Oto

Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment

The Number of Patients With Biopsy Cancer of the Treatment Zone

The Total Number of Patients With Any Adverse Events Related to the Treatment

At 1 month

At 3 month

At 12 month

Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS)

Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM)

Overall Study

CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).

Treatment Planning:

Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the Planning Treatment Volume (PTV) and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively.

CyberKnife radiosurgery

Sean P Collins, MD,PhD

Radiation therapy is a well-established treatment modality for clinically localized prostate cancer. Men who choose to undergo radiation treatments for prostate cancer will have to live with the side effects for many years. Attempts have been made to protect surrounding tissues while delivering high dosage of radiation to cancer. With the rectum being so close to the prostate, many patients still suffer from side effects caused by radiation injury to the rectum, especially those who received conventional external beam radiotherapy.

CyberKnife is an FDA approved radiosurgical devise. Its flexible robotic arm allows radiation beams to be delivered in different directions, providing a highly conformal, uniform dose with steep dose gradients. Therefore, treatment with the CyberKnife radiosurgical system should minimize the toxicity to the surrounding structures. CyberKnife System also incorporates a dynamic tracking system to allow the robot to correct the targeting of therapeutic beams during treatment. These improvements allow for dose escalation within the prostate with less normal tissue toxicity.

The purpose of this study is to estimate the proportion of patients with endoscopically detectable telangiectasia as the indication of radiation injury to the rectum, after CyberKnife Treatment for prostate cancer.

Radiation therapy is a well-established treatment modality for clinically localized prostate cancer. Current techniques include conventional external beam radiotherapy and intensity modulated radiation therapy (IMRT). The efficacy of conventional external beam radiation treatment (60-70 Gy in 2 Gy fractions) using several uniform fields has been documented. The 10-year disease-free survival rate for patients with disease confined to the prostate in the pre-Prostate Specific Antigen (PSA) era was approximately 50-70%. Analysis of these data suggested that dose escalation could improve local control in prostate cancer.

On average, men who choose to undergo radiation therapy treatments for prostate cancer will have to live with the side effects of therapy for many years. Chronic proctitis may occur after radiotherapy (RT) to the pelvic region. According to a published series, it clinically occurs after radiation therapy of localized prostate cancer at a frequency of 5-20%. It occurs months to years after treatment (average 8-12 months) with a large majority within two years following radiation therapy. Patient characteristics, such as a history of inflammatory bowel disease or chronic anticoagulation therapy, may increase an individual patient's risk of clinically significant proctitis. Patients with radiation-induced proctopathy have described symptoms of rectal pain, diarrhea, urgency, rectal bleeding, and increased frequency of bowel movements. Endoscopic evaluation shows telangiectasia, congested mucosa and ulcers. Rectal bleeding occurs from the neovascular telangiectasia seen in about 60% of patients receiving conventionally fractionated radiation therapy. The other symptoms probably develop from the decreased rectal compliance associated with rectal wall fibrosis. These symptoms are, in current reports, most often classified according to the NCI Common Toxicity Criteria grade for late gastrointestinal side effects. Due to the proximity of the rectum and bladder to the prostate, using conventional techniques, the prescription dose is limited to 65-70 Gy. Although attempts were made to protect the rectum, the incidence of rectal bleeding was unacceptable at doses greater than 70 Gy (20%).

The risk of proctitis and rectal bleeding appeared to be dependent upon both the radiation dose and the volume of the rectum in the high dose area. Radiation Oncologists' efforts to optimize the therapeutic ratio for prostate cancer treatment have therefore been directed toward limiting the high dose volume to the prostate while escalation the dose within that volume. Intensity modulated radiation therapy (IMRT) is a widely used technology to achieve this goal. It is accomplished by modulating the radiation beam intensity within each radiation field in accordance with an optimization algorithm. This has allowed greater dose-escalation without evident increase in acute complications, although follow-up is too short to fully assess control and complication rates. Whether IMRT will provide a degree of conformity that proves to eradicate prostate cancer with a high probability while sparing local structures is as yet unresolved.

Late Rectal Mucosal Injury Following CyberKnife RadioSurgery for Clinically Localized Prostate Cancer. The type, extent and incidence of rectal mucosal injury following CyberKnife radiosurgery are currently unknown. The severity of clinical proctitis following radiation therapy is commonly documented using the NCI Common toxicity criteria/Radiation Therapy Oncology Group/EORTC. Unfortunately, clinical proctitis has a low sensitivity for detecting rectal mucosal injury. Endoscopy gives the most accurate estimate of the extent and incidence of rectal mucosal injury. The Vienna rectoscopy score (VRS) was developed to quantify rectal mucosal changes following radiation therapy. In this study, endoscopic evaluation of mucosal damage from CyberKnife treatment will be documented and correlated with gastrointestinal side effects and treatment planning parameters.

Endoscopic Evaluation of Late Rectal Injury Following CyberKnife Radiosurgery for Prostate Cancer

Prospective Endoscopic Safety Evaluation of Late Rectal Mucosal Injury Following CyberKnife Radiosurgery for Clinically Localized Prostate Cancer

Telangiectasia is the primary outcome since it is a measure of tissue fibrosis (primary source of proctitis) and is a well-defined and measurable outcome.

No patients had outcome before the trial was terminated.

Progression-free survival will be defined as the time in months from study entry until progression or death. Patients who are alive and free from progression on the date of closing follow-up will be censored on that date. Data table reports the number of participants who were alive without progression at the end of the study.

Georgetown University

Assistant Professor

A total of 4 subjects out of 40 were accrued for this study. None of the 4 subjects have experienced any adverse events since the start of this study.

CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).

CyberKnife radiosurgery: Treatment Planning:

Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively.

CyberKnife Radiosurgery, Colonoscopy

Age, Categorical

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Sean Collins

Proportion of Patients With Endoscopically Detectable-telangiectasia (VRS Grade 1 or Higher).

CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).

CyberKnife radiosurgery: Treatment Planning:

Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the Planning Treatment Volume (PTV) and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively.

No patients had outcome before the trial was terminated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer	NCT01792024	Stage I Prostat... Stage II Prosta...	Visualase Therm... magnetic resona...	45 Years -	University of Chicago
Endoscopic Evaluation of Late Rectal Injury Following CyberKnife Radiosurgery for Prostate Cancer	NCT01618838	Stage II Prosta...	CyberKnife radi...	18 Years -	Georgetown University
Endoscopic Evaluation of Late Rectal Injury Following CyberKnife Radiosurgery for Prostate Cancer	NCT01618838	Stage II Prosta...	CyberKnife radi...	18 Years -	Georgetown University
Endoscopic Evaluation of Late Rectal Injury Following CyberKnife Radiosurgery for Prostate Cancer	NCT01618838	Stage II Prosta...	CyberKnife radi...	18 Years -	Georgetown University

Spots Global Cancer Trial Database for stage ii prostate carcinoma