Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Adenocarcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Bone Density Conservation Agents

Bicalutamide

Raloxifene Hydrochloride

Androgens

Androgen Antagonists

Hormones

Hormone Antagonists

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Patients receive low dose raloxifene hydrochloride PO daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Patients receive low dose bicalutamide PO daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Patients receive low dose raloxifene hydrochloride PO daily and low dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Patients receive high dose raloxifene hydrochloride PO daily and high dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis

Questionnaire Administration

Erik Castle

This phase II pilot trial studies how well bicalutamide and raloxifene hydrochloride work in treating patients with prostate cancer undergoing surgery. Antihormone therapy, such as bicalutamide and raloxifene hydrochloride, may lessen the amount of androgens made by the body.

PRIMARY OBJECTIVES:

I. To collect and interrogate samples in patients with prostate cancer that were diagnosed with prostate cancer and are planned for radical prostatectomy at Mayo Clinic Arizona.

SECONDARY OBJECTIVES:

I. To describe the adverse event profile and tolerance of therapy for 60 days of treatment prior to surgery.

II. To assess change in stage and/or grade of cancer and prostate specific antigen (PSA) response to neoadjuvant treatment in patients with hormone sensitive prostate cancer.

TERTIARY OBJECTIVES:

I. To evaluate specific pathways and changes when comparing biopsy specimens to prostatectomy.

II. To describe the quality of life of patients receiving hormonal therapy prior to radical prostatectomy.

OUTLINE: This is a dose-escalation study. Patients are randomized to 1 of 4 arms.

ARM A: Patients receive low dose raloxifene hydrochloride orally (PO) daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive low dose bicalutamide PO daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

ARM C: Patients receive low dose raloxifene hydrochloride PO daily and low dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

ARM D: Patients receive high dose raloxifene hydrochloride PO daily and high dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.

Bicalutamide and Raloxifene Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

Neoadjuvant Treatment of Prostate Cancer With Bicalutamide and Raloxifene Prior to Radical Prostatectomy

Will be examined using stream plots and mean plots with associated two-sided 95% confidence intervals.

Continuous biomarker levels will be explored in a graphical manner including mean plots and plots of change and percent change from baseline and other summary measures. Any potential relationships between the baseline level or change in the level of each biomarker and clinical outcome will be further analyzed using Wilcoxon rank sum tests or logistic regression methods, as appropriate. Association between a dichotomized biomarker and overall response will be assessed using a chi-squared test.

Pathways and biomarkers will be compared to similar analyses that have been and will be performed on in vitro and in vivo experiments. Point estimates and two-sided 95% confidence intervals will be computed.

Will be calculated as the total number who were down staged divided by the number of total evaluable patients. A confidence interval for this rate will be calculated based on properties of the binomial distribution. Point estimates and two-sided 95% confidence intervals will be computed.

The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.

Will be calculated and displayed using waterfall plots.

Proportion of patients who complete 60 days of treatment will be calculated as the number of who completed 60 days of treatment divided by the total number of evaluable patients. A confidence interval for this rate will be calculated based on properties of the binomial distribution. The proportion of patients who experience a particular event will be calculated as the total number who experienced the event of interest divided by the number of total evaluable patients, with appropriate confidence interval.

National Cancer Institute (NCI)

Mayo Clinic

Patients undergo 5 fractions of moderate dose SBRT with SIB every other day for 10 days following urethral-sparing IMRT planning.

SBRT: 8.0Gy escalated dose

Patients undergo 5 fractions of uniform dose SBRT every other day for 10 days following urethral-sparing IMRT planning.

SBRT: 7.5Gy conventional dose

Radiation Therapy Treatment Planning and Simulation

SBRT

Zachary Morris

This phase I/II trial studies the side effects and best dose of stereotactic body radiation therapy while using intensity-modulated radiation therapy (IMRT) planning to help avoid radiation to normal tissue in patients with prostate cancer. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using small, high doses of radiation over several days and may cause less damage to normal tissue. This treatment schedule allows for a higher dose of radiation to be administered over a shorter overall treatment period in comparison to standard radiation therapy.

PRIMARY OBJECTIVES:

I. To evaluate the incidence of genitourinary (GU) and gastrointestinal (GI) acute and late toxicity for patients treated with prostate stereotactic body radiotherapy (SBRT) with simultaneous integrative boost, urethral ring sparing, and enhanced prostate localization (magnetic resonance imaging \[MRI\\-computed tomography \[CT\] fusion).

II. To also evaluate the incidence of GU and GI acute and late toxicity for patients treated with prostate stereotactic body radiotherapy (SBRT) with a more conventional and uniformly delivered dose of 7.25 Gy/fraction to the prostate.

III. Disease-free survival: disease-free failure events include local progression, distant progression, biochemical failure as defined by the Radiation Therapy Oncology Group (RTOG) Phoenix definition, and death from any cause.

SECONDARY OBJECTIVES:

I. Evaluate patient quality of life (QOL) using the Expanded Prostate Cancer Index Composite 26 (EPIC-26) for evaluation of the QOL for up to 3 years after the completion of SBRT.

OUTLINE: Participants are assigned to 1 of 2 treatment arms. Participants unable to undergo MRI, whose MRI proves technically inadequate for delineating needed anatomic structures, or who decline to enroll on Arm A are assigned to Arm B.

ARM A: (n = 120) Participants undergo 5 fractions of moderate dose SBRT with simultaneous integrated boost (SIB) every other day for 10 days following urethral-sparing IMRT planning.

ARM B: (n = 40) Participants undergo 5 fractions of uniform dose SBRT every other day for 10 days following undergo urethral-sparing IMRT planning.

After completion of study treatment, patients are followed up at 4-8 weeks, at 4, 8, and 12 months, every 4 months for 1 year, every 6 months for 3 years, and then every 12 months thereafter.

Per protocol amendment in December 2023, the follow up time period for data collection will change to 3 years after the last participant completed treatment.

Stereotactic Body Radiation Therapy With Boost Using Urethral-Sparing Intensity-Modulated Radiation Therapy Planning in Treating Patients With Prostate Cancer

A Phase I/II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Simultaneous Integrated Boost and Urethral-Sparing IMRT Planning

Evaluation of delivering SBRT to the prostate using non-uniform dosing. The investigators will evaluate the potential for any added grade 3 rectal toxicity with the use of a simultaneous integrated boost.

Evaluation of delivering SBRT to the prostate using non-uniform dosing. The investigators will evaluate the potential for any added grade 3 rectal toxicity with the use of a simultaneous integrated boost. A late adverse event will be defined as an adverse event occurring more than 90 days from the completion of RT.

The EPIC 26 assessment has a total range of possible scores of 1-100 where higher scores indicate higher satisfaction. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.

The AUASS has a total possible range of scores of 0-35 where 1-7 is considered mild symptoms, 8-19 is considered moderate symptoms, and 20-35 is considered severe symptoms. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.

The IIEF-5 questionnaire has a total score of 1-25 where 1-7 is considered severe erectile dysfunction (ED), 8-11 is moderate ED, 12-16 is mild-moderate ED, 17-21 is mild ED, and 22-25 is no ED. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.

University of Wisconsin, Madison

Reproductive Control Agents

Micronutrients

Amino Acids

Vitamins

Leuprolide

Goserelin

Tyrosine Kinase Inhibitors

Ascorbic Acid

Methyltestosterone

Testosterone

Testosterone undecanoate

Testosterone enanthate

Testosterone 17 beta-cypionate

Estrogens, Conjugated (USP)

Antioxidants

Protective Agents

Trace Elements

Antineoplastic Agents, Hormonal

Anabolic Androgenic Steroids

Anabolic Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Vitamin C

Patients receive multitargeted tyrosine kinase inhibitor PLX3397 PO BID for 6 months, undergo radiation therapy for 2 months daily (Monday-Friday) beginning at month 3, and undergo ADT with leuprolide acetate, goserelin acetate, or degarelix injections in any month.

Undergo ADT with leuprolide acetate, goserelin acetate, or degarelix

Antiandrogen Therapy

Multitargeted Tyrosine Kinase Inhibitor PLX3397

Radiation Therapy

Elisabeth I. Heath, M.D.

This phase I trial studies the side effects and best dose of multitargeted tyrosine kinase inhibitor PLX3397 (PLX3397) when given together with radiation therapy and antihormone therapy in treating patients with prostate cancer that is at intermediate or high risk of spreading. Multitargeted tyrosine kinase inhibitor PLX3397 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may also help the radiation therapy work better. Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin acetate, or degarelix, may lessen the amount of androgens made by the body. Giving multitargeted tyrosine kinase inhibitor PLX3397 with radiation therapy and antihormone therapy may be a better treatment for prostate cancer.

PRIMARY OBJECTIVES:

I. To conduct a phase I, dose escalation trial with a primary objective of establishing the maximum tolerated dose (MTD) and the dose limiting toxicity (DLT).

SECONDARY OBJECTIVES:

I. To assess the effects of radiation therapy (RT), androgen deprivation therapy (ADT), and PLX3397 (at its MTD) on tumor-associated macrophages (TAMs) in the prostate biopsy after treatment.

OUTLINE: This is a dose-escalation study of multitargeted tyrosine kinase inhibitor PLX3397.

Patients receive multitargeted tyrosine kinase inhibitor PLX3397 orally (PO) twice daily (BID) for 6 months, undergo radiation therapy for 2 months daily (Monday-Friday) beginning at month 3, and undergo ADT with leuprolide acetate, goserelin acetate, or degarelix injections in any month.

After completion of study treatment, patients are followed up at 20-30 days and then every 12 weeks thereafter.

PLX3397, Radiation Therapy, and Antihormone Therapy in Treating Patients With Intermediate- or High-Risk Prostate Cancer

Targeting the Prostatic Tumor Microenvironment With PLX3397, a Tumor-Associated Macrophage Inhibitor in Men With Unfavorable Risk Prostate Cancer Undergoing Radiation Therapy and Androgen Deprivation Therapy

Frequency distributions will be generated by dose level, and overall.

Descriptive statistics will be used to summarize the 7 metabolic syndrome parameters), and changes in them. These statistics will be calculated only for patients treated at the MTD, where the correlatives are measured, and will be generated for all 12 MTD patients combined, and separately by MTD randomization arm.

PSA levels (and their change) will be tabulated for individual patients, regardless of dose level. Descriptive statistics will be used to summarize PSA, and changes in it. Serial PSA levels will be displayed using spaghetti plots, and changes in PSA using waterfall plots.

Frequency distributions will be generated for patients treated at the MTD. Descriptive statistics will be used to summarize all markers, and changes in them.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bicalutamide and Raloxifene Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery	NCT03147196	Stage I Prostat... Stage II Prosta...	Bicalutamide Laboratory Biom... Questionnaire A... Raloxifene Hydr...	40 Years -	Mayo Clinic
Stereotactic Body Radiation Therapy With Boost Using Urethral-Sparing Intensity-Modulated Radiation Therapy Planning in Treating Patients With Prostate Cancer	NCT02470897	Stage I Prostat... Stage II Prosta...	Radiation Thera... SBRT SBRT	-	University of Wisconsin, Madison
Bicalutamide and Raloxifene Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery	NCT03147196	Stage I Prostat... Stage II Prosta...	Bicalutamide Laboratory Biom... Questionnaire A... Raloxifene Hydr...	40 Years -	Mayo Clinic
PLX3397, Radiation Therapy, and Antihormone Therapy in Treating Patients With Intermediate- or High-Risk Prostate Cancer	NCT02472275	Stage I Prostat... Stage II Prosta... Stage III Prost...	Antiandrogen Th... Laboratory Biom... Multitargeted T... Radiation Thera...	18 Years -	Barbara Ann Karmanos Cancer Institute

Spots Global Cancer Trial Database for stage i prostate adenocarcinoma