Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients undergo two biopsies, the first at baseline before start of ADT and the second two months later during brachytherapy.

Biopsy of Prostate

Laboratory Biomarker Analysis

Mitchell Kamrava

This pilot clinical trial studies targeted biopsies in determining response in patients with prostate cancer undergoing high-dose-rate brachytherapy (a type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor). Studying tumor tissue obtained before and after treatment may help doctors understand changes in a pathway that looks at how deoxyribonucleic acid (DNA) is repaired after it is damaged and to see if there are differences in the prostate tissue prior to and after starting androgen deprivation therapy.

PRIMARY OBJECTIVES:

I. Demonstrate feasibility of obtaining adequate tumor tissue from an intra-prostatic index lesion prior to the start of androgen deprivation therapy (ADT) and again at the time of high-dose-rate (HDR) brachytherapy.

SECONDARY OBJECTIVES:

I. Use immunohistochemistry to stain cells pre-ADT and post 2 months of ADT for markers of non-homologous end joining and DNA double strand breaks using the following markers: Ku70, Ku80, DNA-dependent protein kinase catalytic subunits (PKCs), gamma-histone family, member X (H2AX).

OUTLINE:

Patients undergo biopsy at baseline before start of ADT and during brachytherapy.

Targeted Biopsies in Determining Response in Patients With Prostate Cancer Undergoing High-Dose-Rate Brachytherapy

Feasibility of Repeat Targeted Biopsies in Patients Undergoing High-Dose-Rate Prostate Brachytherapy

The prostate biopsy sample at baseline and at the time of brachytherapy (approximately two months later) will be examined to determine if prostate cancer is in the core and if at least 20% of the core has prostate cancer in it.

Jonsson Comprehensive Cancer Center

Symptoms and General Pathology

Neoplasm Metastasis

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Gallium 68 PSMA-11

Radiopharmaceuticals

Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.

68Ga-PSMA-11

Magnetic resonance imaging (MRI)

Positron Emission Tomography (PET)

Andrei Iagaru

This phase 2-3 trial studies the utility of 68-gallium (68Ga)-prostate-specific membrane antigen 11 (PSMA-11) positron emission tomography/magnetic resonance imaging (PET/MRI) to find tumors in patients with prostate cancer who are undergoing resection surgery for prostate cancer that is prognostically expected to spread quickly (intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures, such as PET/MRI, may help find and diagnose prostate cancer, and reveal out how far the disease has spread. Radioactive drugs, such as 68Ga-PSMA-11, may bind to tumor cells that have specific receptors, and may allow doctors to see smaller tumors than the standard of care contrast-enhanced computed tomography (CT) or MRI scan.

OBJECTIVES:

1. To evaluate 68Ga-PSMA-11 PET/MRI for detection of tumor metastases in patients with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection.
2. To assess sensitivity (positive predictive value) and specificity (negative predictive value) of 68Ga-PSMA-11 PET/MRI for the detection of regional nodal metastases compared to pathology at radical prostatectomy.

OUTLINE:

Participants will receive 68Ga-PSMA-11 intravenously (IV). Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.

After completion of study, patients are followed up at 24 to 48 hours.

68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery

68Ga-PSMA-11 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-Risk Prostate Cancer

68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect regional nodal and distant metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. The data will be analyzed by imaging interpretation. Each participant will be interpreted as either positive or negative for the presence of metastatic disease by 68Ga-PSMA PET/MRI, as assessed by imaging interpretation. The outcome will be expressed as the number of participants with metastatic disease, as identified by PET/MRI, a number without dispersion.

Participants that undergo prostatectomy will be evaluated for prostate cancer metastasis to the lymph nodes as determined by histopathology. Each participants will be interpreted as either positive or negative for the presence of metastatic disease by histopathology. The outcome will be expressed as the number of participants with metastatic disease, as identified by histopathology, a number without dispersion.

68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. For participants that undergo both procedures (68Ga-PSMA PET/MRI and prostatectomy), sensitivity of the 68Ga-PSMA PET/MRI detection of metastatic prostate cancer will be determined. For an individual participant, sensitivity means the 2 assessments are in agreement that the participant truly has (ie, true-positive) have the condition being tested for (ie, metastatic prostate cancer). The outcome is reported as the percentage of participants for which the 2 assessments are in agreement that metastatic prostate cancer is detected (true-positive), a number without dispersion.

68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. For participants that undergo both procedures (68Ga-PSMA PET/MRI and prostatectomy), specificity of the 68Ga-PSMA PET/MRI detection of metastatic prostate cancer will be determined. For an individual participant, specificity means the 2 assessments are in agreement that the participant does not (ie, true-negative) have the condition being tested for (ie, metastatic prostate cancer). The outcome is reported as the percentage of participants for which the 2 assessments are in agreement that metastatic prostate cancer is not detected (true-negative), a number without dispersion.

National Cancer Institute (NCI)

Associate Professor of Radiology

Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.

68Ga-PSMA-11: Undergo 68Ga-PSMA-11 PET/MRI Magnetic resonance imaging (MRI): Undergo 68Ga-PSMA-11 PET/MRI Positron Emission Tomography (PET): Undergo 68Ga-PSMA-11 PET/MRI

68Ga-PSMA PET/MRI

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Andrea Otte

68Ga-PSMA-11 PET Detection of Prostate Cancer Metastasized to Lymph Nodes

Some participants elected to have alternatives to prostatectomy, such as external beam radiation or observation.

Histopathologic Detection of Prostate Cancer Metastasized to Lymph Nodes

Sensitivity of 68Ga-PSMA-11 PET/MRI

Specificity of 68Ga-PSMA-11 PET/MRI

Overall Study

Rare Diseases

Kennedy Disease

Antineoplastic Agents

Anti-Inflammatory Agents

Androgens

Hormones

Abiraterone Acetate

Prednisone

Prolactin Release-Inhibiting Factors

Cortisone

Androgen Receptor Antagonists

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Androgen Antagonists

Patients receive androgen receptor antagonist ARN-509 PO daily for 3 months. Patients then undergo radical prostatectomy.

Patients receive GnRH agonist SC on day 1, androgen receptor antagonist ARN-509 PO daily PO for 4 times, abiraterone acetate PO daily for 4 times, and prednisone PO daily for 3 months. Patients then undergo radical prostatectomy.

Androgen Receptor Antagonist ARN-509

Gonadotropin-releasing Hormone Analog

Quality-of-Life Assessment

Questionnaire Administration

Radical Prostatectomy

Isaac Kim, MD

Saum Ghodoussipour, MD

Saum Ghodoussipour

This randomized phase II trial studies how well androgen receptor antagonist ARN-509 works with or without abiraterone acetate, gonadotropin-releasing hormone agonist, and prednisone in treating patients with high-risk prostate cancer undergoing surgery. Androgen can cause the growth of prostate cancer cells. Hormone therapy using androgen receptor antagonist ARN-509, abiraterone acetate, and gonadotropin-releasing hormone analog (GnRH agonist) may fight prostate cancer by lowering the levels of androgen the body makes. Prednisone may either kill the tumor cells or stop them from dividing. Giving androgen receptor agonist ARN-509 with or without abiraterone acetate, GnRH agonist and prednisone may work better in treating patients with prostate cancer.

PRIMARY OBJECTIVES:

I. To evaluate the effect of neoadjuvant androgen receptor antagonist ARN-509 (apalutamide) with or without abiraterone acetate, GnRH agonist, and prednisone on the feasibility of performing nerve-sparing radical prostatectomy (RP) in men with high-risk prostate cancer (PCa).

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive androgen receptor antagonist ARN-509 orally (PO) daily for 3 months. Patients then undergo radical prostatectomy.

ARM II: Patients receive GnRH agonist subcutaneously (SC) on day 1, androgen receptor antagonist ARN-509 PO daily PO for 4 times, abiraterone acetate PO daily for 4 times, and prednisone PO daily for 3 months. Patients then undergo radical prostatectomy.

ARM III: Patients undergo radical prostatectomy.

After completion of study treatment, patients are followed up for 2 years.

Androgen Receptor Antagonist ARN-509 With or Without Abiraterone Acetate, Gonadotropin-Releasing Hormone Analog, and Prednisone in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery

Randomized Three-Arm Trial to Evaluate the Effect of Neoadjuvant Apalutamide Alone or in Combination With Abiraterone Acetate and GnRH Agonist on Enhancing Surgical Outcome of Nerve-Sparing Radical Prostatectomy in Men With High-Risk Prostate Cancer

Each of the experimental arms will be compared to the surgery-only arm, so each test will be a 2.5% level one-sided test to control for the fact that there are two comparisons.

Will be correlated with clinical outcomes before and after androgen receptor antagonist ARN-509 or androgen receptor antagonist ARN-509, GnRH agonist, prednisone plus abiraterone acetate.

Rutgers, The State University of New Jersey

Professor of Surgery, RWJMS

Patients undergo 5, 10, or 15 fractions of hypofractionated SBRT daily over 1-3 weeks.

Stereotactic Body Radiation Therapy

Leslie Ballas

This phase I trial studies the side effects and the best dose of hypofractionated stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that was removed by surgery. Hypofractionated SBRT delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and may have fewer side effects than standard radiation therapy.

PRIMARY OBJECTIVES:

I. To determine maximum tolerated dose-per-fraction for SBRT to the prostate fossa following prostatectomy based on acute toxicity (\< 90 days).

SECONDARY OBJECTIVES:

I. To describe the acute (\< 90 days) toxicities and adverse events associated with hypofractionated SBRT when administered to the prostate bed in the post-prostatectomy setting.

II. To describe the late (\> 90 days from treatment) toxicities and adverse events associated with hypofractionated SBRT when administered to the prostate bed in the post-prostatectomy setting.

TERTIARY OBJECTIVES:

I. To describe the patient-reported toxicity/quality of life (QOL) following hypofractionated SBRT treatment.

OUTLINE: This is a dose-escalation study.

Patients undergo 5, 10, or 15 fractions of hypofractionated SBRT daily over 1-3 weeks.

After completion of study treatment, patients are followed up at 2, 6, and 13 weeks and then at 6, 9, 12, 18, 24, 30 and 36 months.

Hypofractionated Stereotactic Body Radiation Therapy for Patients With Prostate Cancer That Was Removed by Surgery

Phase I Dose-Escalation Study of Hypofractionated SBRT for Adjuvant/Salvage Radiotherapy in Prostate Cancer

Maximum tolerated dose (MTD) is defined as the highest dose tested in which none or only one patient experienced dose limiting toxicity (DLT) attributable to the radiation therapy when 12 patients were treated at that dose and are evaluable for toxicity and is one dose level below the lowest dose level tested where two or more patients experienced radiation associated DLT. All toxicities and side effects of all patients who start SBRT will be recorded and summarized.

All toxicities and side effects of all patients who start SBRT will be recorded and summarized.

University of Southern California

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)

Estrogens

Antioxidants

Protective Agents

Trace Elements

Anabolic Androgenic Steroids

Anabolic Agents

Protein Kinase 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
Targeted Biopsies in Determining Response in Patients With Prostate Cancer Undergoing High-Dose-Rate Brachytherapy	NCT02597894	Stage III Prost...	Biopsy of Prost... Laboratory Biom...	18 Years -	Jonsson Comprehensive Cancer Center
68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery	NCT02678351	Stage II Prosta... Stage III Prost...	68Ga-PSMA-11 Magnetic resona... Positron Emissi...	18 Years -	Stanford University
Androgen Receptor Antagonist ARN-509 With or Without Abiraterone Acetate, Gonadotropin-Releasing Hormone Analog, and Prednisone in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery	NCT02949284	Stage II Prosta... Stage III Prost...	Abiraterone Ace... Androgen Recept... Gonadotropin-re... Prednisone Quality-of-Life... Questionnaire A... Radical Prostat...	-	Rutgers, The State University of New Jersey
Hypofractionated Stereotactic Body Radiation Therapy for Patients With Prostate Cancer That Was Removed by Surgery	NCT02446366	Stage II Prosta... Stage IIB Prost... Stage III Prost...	Laboratory Biom... Quality-of-Life... Stereotactic Bo...	18 Years -	University of Southern California
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 iii prostate adenocarcinoma