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

Patients undergo daily adaptive online replanning for SBRT to the prostate fossa on study. Patients also undergo MRI and may undergo PET/CT during screening.

Patients undergo daily adaptive online replanning for SBRT to the prostate fossa and pelvic lymph nodes on study. Patients also undergo MRI and may undergo PET/CT during screening.

Computed Tomography

Undergo daily adaptive online replanning for SBRT

Image-Guided Adaptive Radiation Therapy

Magnetic Resonance Imaging

Positron Emission Tomography

Questionnaire Administration

Stereotactic Body Radiation Therapy

Bradley J. Stish, M.D.

This clinical trial evaluates the feasibility, safety, and tolerability of stereotactic ablative radiotherapy (SABR) using daily adaptive radiation techniques to the prostate fossa and/or pelvic lymph nodes in patients with prostate cancer who have undergone surgical removal of the prostate (radical prostatectomy). For patients with prostate cancer who develop a rising prostate specific antigen (PSA) after radical prostatectomy, salvage radiation therapy is the standard of care treatment. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. All patients receiving salvage radiation following radical prostatectomy typically have treatment directed to the prostate fossa, which is the anatomical region around the operative bed that is at highest risk for containing left over tumor. Many patients receiving salvage radiation therapy can also benefit from treatment of the pelvic lymph nodes. Adaptive radiotherapy is an emerging treatment technique that uses daily imaging to adjust treatment volumes, ensure accurate dose delivery, and allow the use of smaller planning target volume margins. Adaptive radiation is ideally suited for the further implementation of SABR treatment regimens directed to the prostate fossa with or without inclusion of the pelvic lymph nodes. While daily adaptive radiation therapy has been reported in other disease settings, there is currently no data about its use for post-prostatectomy radiation. Using daily adaptive radiation techniques may help researchers learn how to minimize exposure to normal tissue and shorten the number of required treatments to better target the radiation dose in prostate cancer patients post-prostatectomy.

PRIMARY OBJECTIVE:

I. To demonstrate the safety of daily, adaptive online replanning in patients treated with stereotactic body radiation therapy (SBRT) to the prostate +/- pelvic lymph nodes as defined by observation of a grade 3 genitourinary and gastrointestinal toxicity rate of less than or equal to 5%.

SECONDARY OBJECTIVES:

I. To determine the feasibility of daily, adaptive online replanning for patients receiving SBRT to the prostate fossa +/- pelvic lymph nodes.

II. To assess the efficacy of daily, adaptive SBRT to the prostate fossa. III. To measure the change in patient reported urinary, bowel, and sexual outcomes following protocol treatment.

EXPLORATORY OBJECTIVE:

I. To assess the dosimetric benefits of daily adaptive replanning for prostate fossa/pelvic lymph node SBRT.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP I: Patients undergo daily adaptive online replanning for SBRT to the prostate fossa on study. Patients also undergo (MRI) of the prostate fossa and pelvis and may undergo positron emission tomography/computed tomography (PET/CT) during screening.

GROUP II: Patients undergo daily adaptive online replanning for SBRT to the prostate fossa and pelvic lymph nodes on study. Patients also undergo MRI of the prostate fossa and pelvis and may undergo PET/CT during screening.

Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer

Daily Adaptive Post-Prostatectomy Radiation With Stereotactic Ablative Radiotherapy (DAPPER)

Acute and late Common Terminology Criteria for Adverse Events version 5.0 grade 2 or greater genitourinary and gastrointestinal toxicity will be recorded for all patients. Will report the overall grade 3+ toxicity rate along with a 95% confidence interval for this endpoint. Metrics related to treatment times for each fraction, physician choice of baseline vs adaptive plan, and any potential patient safety issue related to the adaptive planning process will be assessed as well.

Measured by the successful completion of the daily adaptive radiation planning process, allowing the physician to choose this adaptive plan or the preexisting baseline plan. Successful completion of the daily adaptive radiation planning process will be recorded on a per fraction basis for each patient in the Ethos treatment planning system. Will be met if \>= 90% of all fractions are completed. Metrics related to treatment times for each fraction, physician choice of baseline versus (vs) adaptive plan, and any potential patient safety issue related to the adaptive planning process will be assessed as well. Will be reported descriptively, including the overall rates and 95% confidence intervals. The continuous variables will be compared between the groups (baseline vs adaptive plans) using the Wilcoxon Rank-Sum test and categorical variables will associated with the groups via chi-square tests. Graphical methods will be used as well, such as boxplots to display the continuous data

Local failure will be considered to have occurred if the patient develops a biopsy proven or radiographically confirmed site of recurrent disease within a planning target volume at any time following completion of protocol treatment. Patients will be recorded as experiencing an event on the date they were noted to meet the definition for recurrence. Will be reported as cumulative incidence with 95% confidence intervals. All baseline variables will be assessed for correlations with efficacy outcomes using the Wilcoxon Rank-Sum test for continuous variables and chi-square tests for categorical variables. Kaplan-Meier plots will be used as a graphical method to report data.

Biochemical failure is defined by prostate specific antigen (PSA) measurements following treatment. A biochemical failure will be declared if a patient's PSA rises more than 0.4 ng/ml above their post-radiation therapy nadir. Biochemical failure can also occur if a patient begins a new prostate cancer-directed therapy following radiation therapy prior to reaching the PSA threshold for biochemical failure. Patients will be recorded as experiencing an event on the date they were noted to meet the definition for recurrence. Will be reported as cumulative incidence with 95% confidence intervals. All baseline variables will be assessed for correlations with efficacy outcomes using the Wilcoxon Rank-Sum test for continuous variables and chi-square tests for categorical variables. Kaplan-Meier plots will be used as a graphical method to report data.

Distant metastasis is defined as radiographic or histologic confirmed disease progression within non-regional lymph nodes (M1a), bones, or visceral organs. Patients will be recorded as experiencing an event on the date they were noted to meet the definition for recurrence. Will be reported as cumulative incidence with 95% confidence intervals. All baseline variables will be assessed for correlations with efficacy outcomes using the Wilcoxon Rank-Sum test for continuous variables and chi-square tests for categorical variables. Kaplan-Meier plots will be used as a graphical method to report data.

EPIC-26 contains 26 item in 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better Health Related Quality of Life. Will calculate the number of patients experiencing a minimally important difference (MID). MID will be considered a chance of \>0.5 standard deviations from the pre-treatments median score within a specific domain.

EPIC-26 contains 26 item in 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better Health Related Quality of Life. Will measure changes in each domain and report these with 95% confidence intervals over time and associate outcomes with baseline variables.

Mayo Clinic

Principal Investigator

Symptoms and General Pathology

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Uterine Cervical Neoplasms

Syndrome

Carcinoma

Ovarian Neoplasms

Urinary Bladder Neoplasms

Vaginal Neoplasms

Vulvar Neoplasms

Pelvic Neoplasms

Low Anterior Resection Syndrome

Fecal Incontinence

Uterine Neoplasms

Anus Neoplasms

Rectal Diseases

Intestinal Diseases

Gastrointestinal Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Uterine Cervical Diseases

Uterine Diseases

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Colonic Diseases

Postoperative Complications

Vulvar Diseases

Vaginal Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Anus Diseases

Ovarian Cancer

Vaginal Cancer

Anal Cancer

Vulvar Cancer

All Drugs and Chemicals

Neurotransmitter Agents

Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.

Explantation

Quality-of-Life Assessment

Undergo sacral nerve stimulator implantation

Sacral Nerve Stimulator

Undergo sacral nerve stimulator battery implantation

Sacral Nerve Stimulator Battery

Therapeutic Conventional Surgery

Craig A Messick, MD

This phase II trial studies how well sacral nerve stimulation works in treating low anterior resection syndrome or fecal incontinence (the body's passage of stool without control) in patients with rectal cancer that has spread to nearby tissues or lymph nodes, or other pelvic cancer. Sacral nerve stimulation is a permanent implant that may improve bowel functions by stimulating the nerves that control the muscles related to bowel function.

PRIMARY OBJECTIVES:

I. To investigate the efficacy of sacral nerve stimulator placement in patients with fecal incontinence (FI) or low anterior resection syndrome (LARS) who have previously undergone chemoradiation treatment (XRT) and/or a restorative partial or complete proctectomy with colorectal or coloanal anastomosis for cancer treatment as per standard of care (restorative surgery cohort).

II. To evaluate the feasibility of sacral nerve stimulator placement in patients with fecal incontinence (FI) or other defecatory dysfunction who have received pelvic radiation treatment without undergoing rectal or other pelvic surgery as per standard of cancer care (radiation only cohort).

SECONDARY OBJECTIVES:

I. To evaluate the effectiveness of sacral nerve stimulation (SNS) as measured by validated questionnaires in patients with FI or LARS within both patient cohorts.

II. To evaluate pelvic floor and sphincter physiology using anorectal manometry (ARM) before and after SNS in patients with FI or LARS within both patient cohorts.

III. To assess potential impact of SNS on urinary incontinence measuring a post-void urinary bladder residual and validated urinary symptom questionnaires in both patient cohorts.

IV. To assess efficacy of SNS on long-term bowel dysfunction at 1 and 3 years post battery implantation as measured by validated questionnaires for both patient cohorts.

OUTLINE:

Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.

After completion of study, patients are followed up at 1 month, 1 year, and 3 years.

Sacral Nerve Stimulation in Treating Low Anterior Resection Syndrome or Fecal Incontinence in Patients With Locally Advanced Rectal Cancer or Other Pelvic Cancer, the RESTORE Study

A Phase II Study of Sacral Nerve Stimulation for Low Anterior Resection Syndrome or Fecal Incontinence in Patients Following a Low Anterior Resection or Proctectomy With Coloanal Anastomosis or in Patients After Pelvic Chemoradiation (RESTORE)

SNS success will be measured as a patient having the battery implanted at visit 3. Patients who do not have the SNS placed, for any reason other than insurance coverage issues, will count as not having a success. Fecal incontinence will be measured by the physician as the total number of gas, mucus, liquid stool, and solid stool accidental leakage events reported in the bowel diaries. Improvement will be determined by the physician based on bowel diary comparisons recorded before SNS lead placement at visit 1 to after lead placement at visit 2. The proportion of patients who experience SNS success will be reported with a 90% credible interval using a beta (1,1)

Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

Will be measured using bladder diaries and a post-void urinary bladder residual and validated urinary symptom questionnaire.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Experimental: Sacral Nerve Stimulation (SNS)

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Craig Messick

Sacral Nerve Stimulation (SNS) Success

Fecal Incontinence Severity Index Questionnaire Summary

Fecal Incontinence Quality of Life Questionnaire Summary

Euroqol-5 Dimensions-5 Levels (EQ-5D-5L)

International Consultation on Incontinence Society - Female Lower Urinary Tract Symptoms

Memorial Sloan Kettering Cancer Center Bowel Function Questionnaire (BFQ)

Low Anterior Resection Syndrome Score BFQ

Cleveland Clinic Incontinence Score

Impact of SNS on Bowel Dysfunction

Impact of SNS on Urinary Incontinence

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer	NCT05830838	Malignant Prost...	Computed Tomogr... Image-Guided Ad... Magnetic Resona... Positron Emissi... Questionnaire A... Stereotactic Bo...	18 Years -	Mayo Clinic
Sacral Nerve Stimulation in Treating Low Anterior Resection Syndrome or Fecal Incontinence in Patients With Locally Advanced Rectal Cancer or Other Pelvic Cancer, the RESTORE Study	NCT04066894	Low Anterior Re... Malignant Anal ... Malignant Bladd... Malignant Cervi... Malignant Ovari... Malignant Pelvi... Malignant Prost... Malignant Uteri... Malignant Vagin... Malignant Vulva... Rectal Carcinom...	Explantation Quality-of-Life... Questionnaire A... Sacral Nerve St... Sacral Nerve St... Therapeutic Con...	18 Years -	M.D. Anderson Cancer Center
Sacral Nerve Stimulation in Treating Low Anterior Resection Syndrome or Fecal Incontinence in Patients With Locally Advanced Rectal Cancer or Other Pelvic Cancer, the RESTORE Study	NCT04066894	Low Anterior Re... Malignant Anal ... Malignant Bladd... Malignant Cervi... Malignant Ovari... Malignant Pelvi... Malignant Prost... Malignant Uteri... Malignant Vagin... Malignant Vulva... Rectal Carcinom...	Explantation Quality-of-Life... Questionnaire A... Sacral Nerve St... Sacral Nerve St... Therapeutic Con...	18 Years -	M.D. Anderson Cancer Center
Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer	NCT05830838	Malignant Prost...	Computed Tomogr... Image-Guided Ad... Magnetic Resona... Positron Emissi... Questionnaire A... Stereotactic Bo...	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for malignant prostate neoplasm