Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Carcinoma

Adenocarcinoma

Recurrence

Disease Progression

Neoplasms, Second Primary

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients receive enzalutamide PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo a tumor biopsy of a metastatic site at study entry (prior to initiation of enzalutamide) and after the time of progression. Per the investigator, patients may continue treatment beyond progression.

Enzalutamide

Alexandra Sokolova, M.D.

This phase II trial studies genetic and molecular mechanisms in assessing response in patients with prostate cancer receiving enzalutamide therapy. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as enzalutamide, may lessen the amount of androgens made by the body. Studying samples of tissue and blood in the laboratory from patients with prostate cancer may help doctors better understand castration-resistant prostate cancer. It may also help doctors make improvements in prostate cancer treatment.

PRIMARY OBJECTIVE:

I. To assess the correlations between baseline molecular features and pathways and prostate-specific antigen (PSA) change (\</\>= 50% decline) at 12 weeks versus (vs.) baseline.

SECONDARY OBJECTIVES:

I. To measure PSA change at 12 weeks and at each study visit vs. baseline after enzalutamide treatment.

II. To measure objective response after enzalutamide treatment. III. To assess the correlations between the baseline molecular features and pathways and progression-free survival, disease-specific survival, and overall survival.

IV. To assess the correlations between the baseline molecular features and pathways and time to PSA progression.

V. To identify molecular features and cellular pathways present in tumors from men with metastatic castrate-resistant prostate cancer (CRPC) that are progressing despite enzalutamide treatment.

VI. To explore correlation between baseline molecular features and pathways and changes in circulating tumor cells (CTCs) counts.

VII. To explore correlation between baseline molecular features and pathways and objective response.

VIII. To assess the correlations between the baseline molecular features and pathways and degree of PSA decline at 12 weeks and maximal PSA decline observed while on study.

IX. To assess the correlations between the baseline molecular features and time on treatment.

EXPLORATORY OBJECTIVES:

I. To assess correlations between cell-free deoxyribonucleic acid (DNA) (cfDNA) molecular features from blood and molecular features and pathways from the biopsy samples.

II. To assess correlations between cfDNA molecular features and endpoints in the primary and secondary objectives listed above.

III. To assess correlations between cell-free DNA and tumor molecular features and changes in PSA after discontinuing enzalutamide.

IV. To explore correlations with baseline molecular features and tissue histology.

V. To explore correlations with baseline tissue histology and PSA change, time to PSA progression, time on treatment, progression-free survival, and overall survival.

OUTLINE:

Patients receive enzalutamide orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity. Patients undergo a tumor biopsy of a metastatic site at study entry (prior to initiation of enzalutamide) and after the time of progression. Patients may continue treatment beyond progression at the investigator's discretion.

After completion of study treatment, patients are followed up at 2-3 or 6 weeks and then every 12 weeks thereafter.

Genetic and Molecular Mechanisms in Assessing Response in Patients With Prostate Cancer Receiving Enzalutamide Therapy

Molecular Mechanisms Underlying Tumor Progression Despite Enzalutamide Treatment

The percentage of participants with a \>= 50% decline in PSA values will be reported with 95% exact confidence interval. For each participant, percentage decline in PSA values are calculated as 100% times the difference between PSA values taken at baseline and 12 weeks divided by PSA values at baseline. Percentage of participants determined as 100% times the number of participants with \>= 50% decline divided by overall number of participants.

Evaluate the association between PSA response at 12 weeks after initiating therapy, and TP53 copy number alterations and mutations at baseline. Simple Logistic regression was planned but due to sample size we used Fisher's Exact test. Percentage of patients in each arm with TP53 copy number alterations and mutations will be reported and odds ratio with two-sided 95% confidence interval will be calculated.

Evaluate the association between PSA response at 12 weeks after initiating therapy, and PTEN copy number alterations and mutations at baseline. Simple Logistic regression was planned but due to sample size we used Fisher's Exact test. Percentage of patients in each arm with PTEN copy number alterations and mutations will be reported and odds ratio with two-sided 95% confidence interval will be calculated.

Evaluate the association between PSA response at 12 weeks after initiating therapy, and RB1 copy number alterations and mutations at baseline. Simple Logistic regression was planned but due to sample size we used Fisher's Exact test. Percentage of patients in each arm with RB1 copy number alterations and mutations will be reported and odds ratio with two-sided 95% confidence interval will be calculated.

Median AR mRNA expression between responders and non-responders.

Median AR-V7 expression between responders and non-responders.

Evaluate the association between PSA response at 12 weeks after initiating therapy, and AR copy number alterations and mutations at baseline. Simple Logistic regression was planned but due to sample size we used Fisher's Exact test. Percentage of patients in each arm with AR copy number alterations and mutations will be reported and odds ratio with two-sided 95% confidence interval will be calculated.

The number of participants, responders and non-responders, that were found to have protein expression of AR.

Median Normalized Enrichment Score (NES) AR activity levels of responders and non-responders. Gene Set Enrichment Analysis (GSEA) is used to interpret gene expression data. GSEA enrichment score (ES) reflects the degree to which a gene set (GS) is overrepresented at the top or bottom of a ranked list of genes. ES is calculated by walking down the list, increasing a running-sum statistic when a gene is in the GS and decreasing when it's not. Magnitude of increment depends on correlation of the gene with the phenotype. ES is the max deviation from zero encountered in walking the list. Positive ES indicates GS enrichment at the top of the list; negative indicates GS enrichment at the bottom. GSEA calculates NES as actual ES divided by mean (ESs against all permutations of the dataset). Low AR activity has been linked to stemness and lineage plasticity that are recognized as a cause of acquired resistance to AR-targeting therapies.

The percentage of participants with an objective response will be reported with 95% exact confidence interval. Objective radiographic response is evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. For each participant, objective response is calculated as 100% times the difference between the sum of measurable target lesions at baseline and the smallest sum of measurable target lesions achieved after the initiation of therapy, divided by the sum of target lesions at baseline.

Correlations between baseline molecular features and pathways and PFS will be assessed using cox regression model. In addition, Kaplan-Meier plots will be used to graphically illustrate the survival distributions across the strata of categorical molecular predictors.

Correlations between baseline molecular features and pathways and DSS will be assessed using cox regression model. In addition, Kaplan-Meier plots will be used to graphically illustrate the survival distributions across the strata of categorical molecular predictors.

Correlations between baseline molecular features and pathways and OS will be assessed using cox regression model. In addition, Kaplan-Meier plots will be used to graphically illustrate the survival distributions across the strata of categorical molecular predictors.

Correlations between baseline molecular features and pathways and time to PSA progression will be assessed.

Random Forests classification will be used to identify molecular features and pathways present in patients with disease progression or who discontinue Enzalutamide treatment.

Linear regression model will be used to assess the association for changes in CTC counts from baseline and maximal prostate-specific antigen (PSA) observed while on study.

Degree of prostate-specific antigen (PSA) change from baseline to 12 weeks. PSA at week 12 minus PSA at baseline divided by PSA at baseline and multiplied by 100%. Decline shown as negative percent and incline shown as positive percent.

Correlations between baseline molecular features and pathways and maximal PSA decline observed will be assessed. Linear regression model will be used to assess the association for changes in circulating tumor cells (CTC) counts from baseline and maximal PSA observed while on study.

The association between molecular predictors and survival outcomes (e.g., progression-free survival \[PFS\], disease-free survival \[DSS\] and overall survival \[OS\]) and time on treatment will be assessed using cox regression model.

Astellas Pharma US, Inc.

Oregon Health and Science University

OHSU Knight Cancer Institute

Principal Investigator

Adverse events are collected from the start date of treatment with enzalutamide to the last date of treatment with enzalutamide. Adverse events are collected for any untoward clinical experience with the exception of lab abnormalities which are only reported if the test result is deemed Clinically Significant by the responsible or treating physician. Clinical significance is based on clinical judgement and individual patient situation, at the discretion of the physician.

Patients receive enzalutamide PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo a tumor biopsy of a metastatic site at study entry (prior to initiation of enzalutamide) and after the time of progression. Per the investigator, patients may continue treatment beyond progression.

Enzalutamide: Given PO

Treatment (Enzalutamide)

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Shawna Bailey, Data Manager

Evaluable patients will include those patients for whom data from genomic studies and IHC tests are available from the pre-treatment biopsy samples and who have completed at least 12 weeks of therapy or who have confirmed disease progression prior to 12 weeks of therapy, and for whom baseline and 12 week PSA data were available. 36 subjects shown in participant flow. 2 subjects were excluded from this PSA analysis: 1 had missing PSA data, 1 had falling PSA in setting of rapid disease progression

Percentage of Participants With a >= 50% Decline in Prostate-specific Antigen (PSA) Value

PSA Responder: A ≥ 50% reduction at 12 weeks after the initiation of therapy vs. baseline. Baseline PSA will be defined as the measurement obtained immediately prior to initiation of Enzalutamide on Day 1 of study.

Responders

PSA Non-Responder: A less than 50% reduction at 12 weeks after the initiation of therapy vs. baseline. Baseline PSA will be defined as the measurement obtained immediately prior to initiation of Enzalutamide on Day 1 of study.

PSA Non-responders

For the primary endpoint, evaluable patients will include those patients for whom data from genomic studies and IHC tests are available from the pre-treatment biopsy samples and who have completed at least 12 weeks of therapy or who have confirmed disease progression prior to 12 weeks of therapy. Targeted DNA sequencing was performed on 26 of 36 biopsies that contained sufficient material.

Percentage of Participants With Tumor Protein 53 Gene (TP53) Copy Number Alterations and Mutations

Percentage of Participants With Phosphatase and Tensin Homologue Gene (PTEN) Copy Number Alterations and Mutations

Percentage of Participants With Retinoblastoma Gene (RB1) Copy Number Alterations and Mutations

Non-responders

Evaluable patients will include those patients for whom data from genomic studies and IHC tests are available from the pre-treatment biopsy samples and who have completed at least 12 weeks of therapy or who have confirmed disease progression prior to 12 weeks of therapy, and for whom baseline and 12 week PSA data were available. RNA sequencing was performed on 25 of 36 biopsies that contained sufficient material.

Androgen Receptor (AR) Messenger RNA (mRNA) Expression

Androgen Receptor Variant 7 (AR-V7) Expression

PSA non-responders: A less than 50% reduction at 12 weeks after the initiation of therapy vs. baseline. Baseline PSA will be defined as the measurement obtained immediately prior to initiation of Enzalutamide on Day 1 of study.

For the primary endpoint, evaluable patients will include those patients for whom data from genomic studies and IHC tests are available from the pre-treatment biopsy samples and who have completed at least 12 weeks of therapy or who have confirmed disease progression prior to 12 weeks of therapy. AR immunohistochemistry was available in 22 patients with sufficient samples.

Percentage of Participants With Androgen Receptor (AR) Copy Number Alterations and Mutations

For the primary endpoint, evaluable patients will include those patients for whom data from genomic studies and IHC tests are available from the pre-treatment biopsy samples and who have completed at least 12 weeks of therapy or who have confirmed disease progression prior to 12 weeks of therapy. AR protein expression was analyzed using immunohistochemical analysis from 21 patients with sufficient samples.

Number of Participants With Protein Expression of AR

Androgen Receptor (AR) Activity Level

Prostate-specific Antigen (PSA) Changes

Only those subjects who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for objective response.

Percentage of Participants With an Objective Response

Progression-free Survival (PFS)

Disease-specific Survival (DSS)

Overall Survival (OS)

Time to Prostate-specific Antigen (PSA) Progression

Molecular Features and Cellular Pathways Present in Tumors That Are Progressing Despite Treatment With Enzalutamide

Changes in Circulating Tumor Cell (CTC) Counts

Degree of Prostate-specific Antigen (PSA) Decline

Maximal Prostate-specific Antigen (PSA) Decline Observed

Time on Treatment

Overall Study

Neoplasm Metastasis

Lymphatic Metastasis

Neoplastic Processes

All Drugs and Chemicals

Antineoplastic Agents

Micronutrients

Vitamins

Androgens

Hormones

Axitinib

Androgen Antagonists

Ascorbic Acid

Methyltestosterone

Testosterone

Testosterone undecanoate

Testosterone enanthate

Testosterone 17 beta-cypionate

Estrogens, Conjugated (USP)

Estrogens

Hormone Antagonists

Antioxidants

Protective Agents

Trace Elements

Antineoplastic Agents, Hormonal

Anabolic Androgenic Steroids

Anabolic Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

Vitamin C

Patients receive antiandrogen therapy per standard care and axitinib PO BID for 4 months. Patients then undergo radical prostatectomy and pelvic lymph node dissection.

Patients receive antiandrogen therapy per standard care for 4 months and then undergo radical prostatectomy and pelvic lymph node dissection.

Antiandrogen Therapy

Radical Prostatectomy

Regional Lymph Node Dissection

Amado J Zurita Saavedra

This randomized phase IIA trial studies how well antiandrogen therapy works with or without axitinib before surgery in treating patients with previously untreated prostate cancer that is known or suspected to have spread to lymph nodes. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as antiandrogen therapy may lessen the amount of androgen made by the body. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if antiandrogen therapy is more effective with or without axitinib before surgery in treating patients with prostate cancer.

PRIMARY OBJECTIVES:

I. To compare the proportion of patients progression-free one year after treatment with axitinib plus androgen deprivation versus (vs.) androgen deprivation therapy alone and surgery in newly diagnosed prostate cancer patients with lymph node metastases (TxN1M0 or TxNxM1a) or clinical suspicion of lymph node metastases.

SECONDARY OBJECTIVES:

I. To compare the rate of pathologic complete response (pCR) in the primary tumor.

II. To evaluate time to progression. III. Describe the perioperative and postoperative morbidity of pre-surgical treatment.

IV. Evaluate the effects of a 6-month time course of androgen deprivation with or without axitinib in prostate cancer tissue and blood.

V. Develop a prospective tissue archive of prostate tumors that have metastasized to lymph nodes.

OUTLINE:

Patients receive antiandrogen therapy per standard care for 8 weeks.

Patients are then randomized to 1 of 2 treatment arms.

ARM I: Patients receive antiandrogen therapy per standard care and axitinib orally (PO) twice daily (BID) for 4 months. Patients then undergo radical prostatectomy and pelvic lymph node dissection.

ARM II: Patients receive antiandrogen therapy per standard care for 4 months and then undergo radical prostatectomy and pelvic lymph node dissection.

After completion of study treatment, patients are followed up at 1 and 3 months, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then yearly thereafter.

Antiandrogen Therapy With or Without Axitinib Before Surgery in Treating Patients With Previously Untreated Prostate Cancer With Known or Suspected Lymph Node Metastasis

Pre-Surgical Androgen Deprivation Therapy With or Without Axitinib in Previously Untreated Prostate Cancer Patients With Known or Suspected Lymph Node Metastasis

Time to Prostate-specific antigen (PSA)-progression measured from the date of radical prostatectomy to the occurrence of a serum PSA \>1.0 ng/mL (confirmed by a second measurement at least 2 weeks apart). PSA-monitoring every 3 months after surgery for the first 12 months, every 4 months in the second year, every 6 months in the third to fifth year, and yearly thereafter until PSA or radiologic progression.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.

Laboratory Biomarker Analysis

Quality-of-Life Assessment

Stereotactic Body Radiation Therapy

Nicholas Nickols, MD, PhD

This phase I trial studies stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Delivering radiotherapy before prostatectomy by SBRT is more convenient, conformal, and may spare normal tissues better than delivering radiotherapy after prostatectomy.

PRIMARY OBJECTIVES:

I. To assess feasibility of pre-operative stereotactic body radiotherapy (SBRT) in prostate cancer patients at high risk for recurrence after prostatectomy.

SECONDARY OBJECTIVES:

I. To assess safety and acute toxicity of SBRT followed by prostatectomy. This will be based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and patient reported quality of life (Expanded Prostate Cancer Index Composite \[EPIC\] and International Prostate Symptom Score \[IPSS\] questionnaires).

II. Investigation of the radiobiology of SBRT in prostate cancer using resected prostate tumor tissue.

III. Evaluation of the nature of the immune response to prostate cancer generated by SBRT.

OUTLINE:

Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.

After completion of the study treatment, patients are followed up at 0 to 4 weeks, and every 3 months for 1 year.

Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery

Phase I Feasibility Trial of Preoperative Adjuvant Stereotactic Body Radiotherapy for Patients at High Risk of Local Failure After Prostatectomy

Based on the Common Terminology Criteria for Adverse Events (CTCAE) v4. Grade refers to the severity of the adverse event. Indications are Grade 1 is Mild, Grade 2 is Moderate, Grade 3 is Severe or medically significant but not immediately life threatening. Grade 0 refers to absence of an adverse event (ae).

The Expanded Prostate Cancer Index Composite Short Form (EPIC-26) is composed of 26 items and measures health-related quality of life across 5 prostate cancer domains. 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 a better quality of life.

The International Prostate Symptom Score is composed of seven questions and scored from 0 - 35, with higher scores indicating more severe symptoms.

Tissue specimens of the primary tumor as well as blood draws before and after treatment will be used to conduct biomarker and molecular analyses relevant to understanding the biology of prostate SBRT

Jonsson Comprehensive Cancer Center

Stereotactic Body Radiation Therapy (SBRT)

Gleason grade assigned based on predominant pattern in biopsy + a second Gleason grade to the second most predominate pattern. The two grades are added together to determine the Gleason score. Assigned Gleason scores range from 6 - 10, with 6 being low grade or better and 10 is high grade or worse.

Gleason Grade

Primary tumor, regional nodes, metastasis (TNM) staging system: A system to describe the amount and spread of cancer in a patient's body, using TNM. T describes the size of the tumor and any spread of cancer into nearby tissue; N describes spread of cancer to nearby lymph nodes; and M describes metastasis (spread of cancer to other parts of the body). Larger numbers indicate worse indication.

CStage

Nicholas Nickols, MD

Treatment Stereotactic Body Radiotherapy (SBRT)

Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications

Genitourinary Toxicities

Gastrointestinal toxicities

Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities

Urinary Incontinence

urinary irritative/obstructive

Bowel

Sexual Function

Hormonal

Change in score from baseline at 12 months. Quality-of-Life Assessment: Ancillary studies

Mean change in EPIC-26 score from baseline to 12 months. Three patients dd not complete the QOL assessment and therefore were not included in the analysis.

Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring.

Three patients dd not complete the QOL assessment and therefore were not included in the analysis.

Changes in Quality of Life as Measured on the International Prostate Symptom Score (IPSS) Questionnaire.

CD11b

CD68

CD163

Post SBRT and Radical Prostatectomy (RP)

Pre-treatment biopsies and surgical specimens from this trial were used to determine radiation-induced changes in macrophage subsets. Six participants had available paired biopsy cores and Radical Prostatectomy (RP) specimens for analysis.

Correlative Biomarker Analyses Using Tissue and Serial Blood Samples

CD3+CD8

CD3+CD4

CD4+FOXp3

Pre-treatment biopsies and surgical specimens from this trial were used to determine radiation-induced changes in T cell. Six participants had available paired biopsy cores and RP specimens for analysis.

Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.

Prolactin Release-Inhibiting Factors

Patients undergo SBRT QOD for 14 days. Patients may also receive ADT comprised of a luteinizing hormone-releasing hormone agonist or a gonadotropin-releasing hormone antagonist, and an oral anti-androgen for 6 months at the discretion of the treating physician.

Receive luteinizing hormone-releasing hormone agonist or gonadotropin-releasing hormone antagonist, and oral anti-androgen

Amar Kishan, MD

This phase II trial studies how well stereotactic body radiation therapy works in treating patients with prostate cancer that has not spread to other parts of the body and have undergone surgery. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue.

PRIMARY OBJECTIVES:

I. To determine the efficacy of postoperative stereotactic body radiation therapy (SBRT) at a dose of 34 grays (Gy) in five fractions, as compared with historical control efficacy rates in patients who received conventionally fractionated postoperative radiotherapy.

II. To determine the toxicity of postoperative SBRT at a dose of 34 Gy in five fractions, both via physician-scored and patient-reported metrics.

SECONDARY OBJECTIVES:

I. To determine the proportion of SBRT fractions for which on-line adaptive radiotherapy is required due to changes in organ-at-risk anatomy, in the subset of patients treated with magnetic resonance imaging (MRI)-guided radiotherapy.

II. To gather biomarkers that may elucidate predictors of increased efficacy or increased toxicity.

TERTIARY OBJECTIVES:

I. To compare toxicity profiles (both physician-scored and patient-reported) between patients treated utilizing a linear accelerator versus a tri-60Co teletherapy platform.

OUTLINE:

Patients undergo SBRT every other day (QOD) for 14 days. Patients may also receive androgen deprivation therapy (ADT) comprised of a luteinizing hormone-releasing hormone agonist or a gonadotropin-releasing hormone antagonist, and an oral anti-androgen for 6 months at the discretion of the treating physician.

After completion of study treatment, patients are followed up at 1 month, every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery

Prospective Study of Stereotactic Body Radiotherapy (SBRT) Following Radical Prostatectomy

Comparative analysis will be performed to assess physician-scored toxicity profiles for treated utilizing a linear accelerator. Unpaired t-test or Wilcoxon rank sum test will be used for quantitative toxicity metrics.

Comparative analysis will be performed to assess patient-reported toxicity profiles for treated utilizing a linear accelerator. Unpaired t-test or Wilcoxon rank sum test will be used for quantitative toxicity metrics.

Comparative analysis will be performed to assess toxicity profiles with patients treated utilizing a linear accelerator. Chi-square test or Fisher's exact test will be used for qualitative toxicity measurements, while unpaired t-test or Wilcoxon rank sum test will be used for quantitative toxicity metrics.

Comparative analysis will be performed to assess patient-reported toxicity profiles for treated utilizing an MRI-guided radiotherapy device. Unpaired t-test or Wilcoxon rank sum test will be used for quantitative toxicity metrics.

Defined as serum prostate-specific antigen (PSA) rising from the post-treatment nadir to a level of 0.4 ng/mL or more with a confirmatory second test, initiation of salvage androgen deprivation therapy, or continued rise in PSA after stereotactic body radiation therapy (SBRT). The Kaplan-Meier product-limit estimate of the BCRFS will be estimated and presented graphically. One sample log-rank test will be used to test difference in BCRFS between intervention and historical control. The median BCRFS time will be calculated with 95% confidence interval. Summaries of the number and percentage of patients experiencing a biochemical recurrence will be provided.

Represented by the rates of acute (early, within 90 days of SBRT) and late (90 or more days after SBRT) genitourinary and gastrointestinal toxicity based on the Common Terminology Criteria for Adverse Events version 4.03. Adverse Events (AEs) and serious adverse events (SAEs) will be listed individually by patient.

Patient-reported toxicity outcomes represented by changes in the urinary incontinence, urinary obstruction, bowel, sexual function, and hormone/vitality domains on the Expanded Prostate Cancer Index-26 (EPIC-26) quality of life instrument (scored from 0-100 points for each domain, higher scores reflect worse symptom/bother severity.)

Patient-reported toxicity outcomes represented by changes in International Prostate Symptom Scores (IPSS) (scored from 0-35 points, higher scores reflect worse symptom/bother severity.).

Point estimate and the corresponding 95% confidence interval will be calculated for the proportion of SBRT fractions for which on-line adaptive radiotherapy is required due to changes in organ-at-risk anatomy, in the subset of patients treated with MRI-guided radiotherapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Genetic and Molecular Mechanisms in Assessing Response in Patients With Prostate Cancer Receiving Enzalutamide Therapy	NCT02099864	Castration-Resi... Metastatic Mali... Metastatic Mali... Metastatic Pros... Recurrent Prost... Stage III Prost... Stage IV Prosta...	Enzalutamide	18 Years -	OHSU Knight Cancer Institute
Antiandrogen Therapy With or Without Axitinib Before Surgery in Treating Patients With Previously Untreated Prostate Cancer With Known or Suspected Lymph Node Metastasis	NCT01409200	Metastatic Mali... Prostate Ductal... Stage III Prost... Stage IV Prosta...	Antiandrogen Th... Axitinib Radical Prostat... Regional Lymph ...	18 Years -	M.D. Anderson Cancer Center
Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery	NCT02830165	Stage I Prostat... Stage II Prosta... Stage III Prost...	Laboratory Biom... Quality-of-Life... Stereotactic Bo...	18 Years -	Jonsson Comprehensive Cancer Center
Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery	NCT03541850	PSA Level Great... PSA Progression Stage I Prostat... Stage II Prosta... Stage III Prost...	Antiandrogen Th... Quality-of-Life... Stereotactic Bo...	18 Years -	Jonsson Comprehensive Cancer Center
Itraconazole in Treating Patients With Biochemically Relapsed Prostate Cancer	NCT01787331	Prostate Adenoc... Recurrent Prost... Stage I Prostat... Stage II Prosta... Stage III Prost...	Itraconazole Laboratory Biom... Pharmacological...	18 Years -	University of California, San Francisco
Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery	NCT03541850	PSA Level Great... PSA Progression Stage I Prostat... Stage II Prosta... Stage III Prost...	Antiandrogen Th... Quality-of-Life... Stereotactic Bo...	18 Years -	Jonsson Comprehensive Cancer Center

Spots Global Cancer Trial Database for stage iii prostate adenocarcinoma ajcc v7