Wednesday, December 7, 2022

Nih Prostate Cancer Clinical Trials

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Parp Inhibitors For Prostate Cancer

At the NIH Clinical Center: Anna Brown studies better ways to diagnose prostate cancer

A PARP inhibitor is a substance that blocks an enzyme in cells called PARP. PARP helps repair DNA when it becomes damaged. Some prostate tumors have genetic defects that limit their ability to repair DNA damage. Such tumors may be sensitive to PARP inhibitors.

Two PARP inhibitors, olaparib and rucaparib , have been approved for some men whose prostate cancer has metastasized, and whose disease has stopped responding to standard hormone treatments.

Safety Pharmacokinetic And Proof

Sorry, in progress, not accepting new patients

The purpose of this study is to assess the safety and activity of ARN-509 in men with advanced castration resistant prostate cancer. Patients will first be enrolled into Phase 1 of the study to identify a tolerable dose for the Phase 2 portion of the study. In the Phase 2, 3 different cohorts of patients will be enrolled to evaluate the safety and activity of ARN-509.

San Francisco, California

Effectiveness Of Open And Robotic Prostatectomy

Sorry, in progress, not accepting new patients

Prostate cancer is the most common cancer in American men. Surgical removal of the entire prostate is one option among the various ways to treat prostate cancer. The use of robot assistance for prostatectomy has become common place, but its effectiveness has not been compared to standard open prostatectomy in trials carried out at more than one medical institution in which participants are identified and followed forward in time. Robot assisted and standard open prostatectomy health related quality of life outcomes have not been compared in a prospective, multi-centered study. Prostatectomy can have side effects that can change with time. This research study seeks to determine how common and how long-lasting such side effects are to find out what features of individual men’s cancers and what features of the treatments affect those side effects. This study also seeks to identify factors that affect the quality of prostate cancer care by looking at how satisfied men are with their prostate cancer care. Through these findings, this study aims to allow treatment side effects to be anticipated more accurately for individual patients, and to provide a means for determining the quality of prostate care.

San Francisco, California

Recommended Reading: What Is The Treatment For Prostate Cancer

Cdk4/6 And Cell Cycle

Hyperproliferation is a hallmark of cancer development. The cell cycle can be divided into four ordered phases: G1 , S , G2 , and M , which are precisely controlled by molecules such as CDKs. The key regulatory checkpoints in the G1 and G2 phases determine whether cells enter the S phase and mitosis. CDK4 and CDK6, two serine/threonine kinases, are crucial for governing the transition from the G1 to S phase.352 CDK4/6 is activated by the binding of cyclin D1/2/3 during the early G1 phase in response to mitogenic stimuli. The cyclin D-CDK4/6 complexes subsequently phosphorylate and inactivate the retinoblastoma tumor suppressor protein.353,354 RB proteins typically bind to the transcription factor E2Fs, such as E2F1, to limit the expression of many E2F target genes that are involved in the cell cycle and mitotic progression.355,356 Phosphorylation by CDK4/6 reduces the binding affinity of RB to E2F, leading to transactivation of E2F transcription factors such as E2F1 .1c). Activated E2F1 recruits RNA-POLII to induce the transcription of CDK2, E-type cyclins, and other cell cycle-related proteins that further phosphorylate RB and promote the G1-to-S-phase cell cycle transition.357,358 CDK4/6 also phosphorylates other substrates and plays an important role in differentiation and metabolism.359,360

A Study Of Abiraterone Acetate Plus Prednisone With Or Without Abemaciclib In Participants With Prostate Cancer

Annual Report to the Nation: overall cancer mortality continues to ...

Sorry, not currently recruiting here

This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer. Prednisolone may be used instead of prednisone per local regulation.

La Jolla, California

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Two Studies For Patients With High Risk Prostate Cancer Testing Less Intense Treatment For Patients With A Low Gene Risk Score And Testing A More Intense Treatment For Patients With A High Gene Risk Score The Predict

open to eligible males ages 18 years and up

This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score.

San Mateo, California

A Parallel Arm Phase 1b/2a Study Of Dkn

Sorry, in progress, not accepting new patients

This is a non-randomized multi-center Phase 1b/2a dose escalation and dose expansion study involving 85-97 patients testing DKN-01 as monotherapy or in combination with docetaxel in metastatic castration-resistant prostate cancer. Patients need to be biomarker positive either in plasma or biopsy. Other biopsies for correlative studies are encouraged but not mandatory. Pharmacokinetic testing of one pre-treatment blood sample and one post-treatment blood sample will be mandatory on Day 1 of every cycle.

San Francisco, California

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Testing The Addition Of The Drug Apalutamide To The Usual Hormone Therapy And Radiation Therapy After Surgery For Prostate Cancer

open to eligible males ages 18 years and up

This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or reduce the growth of prostate cancer cell growth by blocking the attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading and extend time without disease spreading compared to the usual approach.

San Francisco, California and other locations

Nivolumab Combined With Ipilimumab For Patients With Advanced Rare Genitourinary Tumors

Apalutamide for High-Risk Prostate Cancer | Learn About Clinical Trials

open to eligible people ages 18 years and up

This research study is studying a combination of drugs as a possible treatment for rare genitourinary malignancies among four cohorts, bladder or upper tract carcinoma with variant histology, adrenocortical carcinoma, other rare genitourinary carcinomas and any genitourinary carcinoma with neuroendocrine differentiation. Given preliminary results, the study is being tested in additional patients with bladder or upper tract carcinoma with variant histology at this time while the adrenocortical carcinoma, other rare genitourinary malignancies arms have closed to accrual -The names of the study drugs involved in this study are: – Nivolumab – Ipilimumab

La Jolla, California

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Muscadine Plus In Men With Prostate Cancer

Sorry, in progress, not accepting new patients

This research is being done to determine if men with rising PSA after initial therapy for localized prostate cancer who display the Alanine/Alanine SOD2 genotype of MnSOD and supplement their diet with MPX have greater decrease in PSA slope following treatment compared to men that do not supplement with MPX.

La Jolla, California

Will My Information Be Kept Confidential

As much as possible, your personal and medical information will be kept confidential. Of course your cancer care team needs this data to give you the best possible care, just as they would if you were not in a clinical trial.

Information thats needed for the clinical trial, such as test results, is put on special forms and into computer systems. This is only shared with the people who analyze the study results. Your data is given a number or code your name isnt on the forms or in the study system. Sometimes, members from the research team or from the FDA might need to look at your records to be sure the data they were given is correct. But your personal information isnt given to them and is never used in any published clinical trial results.

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Targeted Radiation Therapy And Psma

Scientists are also developing targeted therapies based on PSMA, the same protein that is being tested for imaging prostate cancer. For treatment, the molecule that targets PSMA is chemically linked to a radioactive compound. This new compound can potentially find, bind to, and kill prostate cancer cells throughout the body.

In a recent clinical trial, men with a type of advanced prostate cancer who received a PSMA-targeting drug lived longer than those who received standard therapies. Ongoing and planned clinical trials are testing PSMA-targeting drugs in patients with earlier stages of prostate cancer, and in combination with other treatments, including targeted therapies like PARP inhibitors and immunotherapy.

What Causes Fatigue During Radiation Treatment In Men With Prostate Cancer

Pin on Prostate Cancer

The National Institute of Nursing Research at the National Institutes of Health Clinical Center seeks men with prostate cancer to join a research study about the causes of fatigue during radiation treatment. Researchers also want to learn if exercise can help reduce this type of fatigue. The study involves at least 10 outpatient visits to the NIH Clinical Center . Participants will have the option to complete an 8-week treadmill exercise program as part of the study.

You may be eligible if you:

  • Are male, 18 years or older
  • Have been diagnosed with prostate cancer

You may not be eligible if you:

  • Have a chronic inflammatory disease
  • Have an infectious disease
  • Have had a major psychiatric problem within the last five years
  • Have another type of cancer
  • Are receiving chemotherapy

There is no charge for study-related procedures.

The study is located at the NIH Clinical Center, America’s research hospital, on the Metro red line in Bethesda, Maryland.

For more information, call us:1-866-444-2214 se habla español

Also Check: Can You Beat Stage 4 Prostate Cancer

Active Surveillance Exercise Clinical Trial

open to eligible males ages 18 years and up

This phase 2, open-label, dual-center, two-arm randomized controlled trial investigates the effects of 16 weeks of structured aerobic training, relative to usual care . Prostate genomic signatures represent the functional activity of all genes in the genome and are converted into genomic risk scores which correspond to the probability of a progression event . A structured exercise program may alter the genomic risk score and improve prediction of aggressive disease.

San Francisco, California

Hormone Therapy Radiation Therapy And Steroid 17alpha

Sorry, in progress, not accepting new patients

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as steroid 17alpha-monooxygenase TAK-700, when used with other hormone therapy, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for prostate cancer when combined with hormone therapy. Studying quality-of-life in patients having cancer treatment may help identify the intermediate- and long-term effects of treatment on patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying the use of hormone therapy, including TAK-700, together with radiation therapy in treating patients with prostate cancer.

San Francisco, California

Also Check: Is Prostate Cancer Genetically Linked

Us Government Clinical Trial Listings

ClinicalTrials.gov. This government database lists publicly and privately supported clinical trials. The National Library of Medicine at the National Institutes of Health maintains the website. It provides information on thousands of studies. The research addresses various disease and conditions, including cancer. Studies take place in all 50 states and internationally.

National Cancer Institute Clinical Trials. This federal agency provides funding for most U.S. cancer clinical trials. The site lists open and closed cancer clinical trials sponsored or supported by NCI. Find NCI-supported clinical trials with the search tool.

Personalized Clinical Trials For Prostate Cancer

VERU-944 to Improve Hot Flashes in Men With Advanced Prostate Cancer | Learn Clinical Trials

Research is uncovering more information about the genetic changes that happen as prostate cancers develop and progress. Although early-stage prostate cancer has relatively few genetic changes compared with other types of cancer, researchers have learned that metastatic prostate cancers usually accumulate more mutations as they spread through the body.

These mutations may make men with metastatic prostate cancers candidates for what are called basket clinical trials of new drugs. Such trials enroll participants based on the mutations found in their cancer, not where in the body the cancer arose. In the NCI-MATCH trial, a high percentage of enrolled men with advanced prostate cancer had mutations that could potentially be targeted with investigational drugs.

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Pilot Study Of Imaging With Pyruvate To Detect High Grade Prostate Cancer

Sorry, in progress, not accepting new patients

This pilot clinical trial studies how well magnetic resonance spectroscopic imaging with hyperpolarized carbon C13 pyruvate works in finding prostate cancer that exhibits poorly differentiated or undifferentiated cells and that is restricted to the site of origin, without evidence of spread in patients undergoing radical prostatectomy. Diagnostic procedures, such as MRSI with hyperpolarized carbon C13 pyruvate, may aid in the diagnosis of prostate cancer and in discriminating high-grade from low-grade prostate cancer and benign adjacent prostate tissue

San Francisco, California

A New Treatment For Advanced Prostate Cancer Improves Survival In Phase 3 Clinical Trial

  • By Charlie Schmidt, Editor, Harvard Medical School Annual Report on Prostate Diseases

Radiation therapy is getting more precise, enabled by technologies that make it easier to kill tumors while sparing their surrounding tissues. Some newer therapies are even given intravenously instead of by machines, and they deliver radiation particles directly to the cancer cell itself. One of these new therapies a sort of smart bomb targeted at malignant cells is now generating promising data for men with the most aggressive prostate cancer.

In early June, investigators reported results from a phase 3 clinical trial showing that among men who received the experimental treatment, there was nearly a 40% reduction in deaths over the course of the study, compared to men who did not.

The treatment is called lutetium-177-PSMA-617, or LuPSMA, and it has two components: a compound that targets a cancer cell protein called prostate-specific membrane antigen, or PSMA, and a radioactive particle that destroys the cells. Healthy prostate cells don’t contain PSMA, or do at very low levels. And some men with prostate cancer have more of the protein than others. Doctors can detect the protein using a specialized imaging scan.

Results after 21 months showed that cancer progression was delayed for longer among the LuPSMA-treated men: 8.7 months on average versus 3.4 months among the controls. The treatment was also associated with better overall survival: 15.3 months versus 11.3 months.

Recommended Reading: How To Massage Own Prostate

A Study Of Xmab20717 In Subjects With Selected Advanced Solid Tumors

Sorry, in progress, not accepting new patients

This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb20717 in subjects with selected advanced solid tumors.

San Francisco, California

Prostvac In Preventing Disease Progression In Patients With Localized Prostate Cancer Undergoing Active Surveillance

Cancers

Sorry, in progress, not accepting new patients

This randomized phase II trial studies how well PROSTVAC works in preventing disease progression in patients with prostate cancer undergoing active surveillance. Vaccines made from a person’s tumor cells may help the body build an effective immune response to kill tumor cells that express PSA.

San Diego, California

Read Also: What’s A Prostate Exam

Immunotherapy In Patients With Metastatic Cancers And Cdk12 Mutations

Sorry, in progress, not accepting new patients

This study will attempt to determine the efficacy of checkpoint inhibitor immunotherapy with nivolumab and ipilimumab combination therapy followed by nivolumab monotherapy in patients with metastatic prostate cancer and other tumor solid tumor histologies harboring loss of CDK12 function as well as monotherapy nivolumab treatment in patient with metastatic prostate cancer harboring loss of CDK12 function.

San Francisco, California

Study Of Pembrolizumab Plus Docetaxel Versus Placebo Plus Docetaxel In Chemotherapy

Sorry, in progress, not accepting new patients

The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent . There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival . Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Radiographic Progression-free Survival per Prostate Cancer Working Group -modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review.

San Francisco, California

Also Check: How Successful Is Brachytherapy For Prostate Cancer

Availability Of Cancer Facilities

Among a total of 3145 counties, there were 931 counties with at least 1 cancer care facility . Specifically, there were 637 NCORP sites among 501 counties and 41 NCI comprehensive cancer centers among 40 counties. A total of 1421 ACS cancer centers were found among 673 counties, and 172 USON sites were found in 108 counties.

Table 1 shows that although counties with a higher proportion of African Americans were more likely, on average, to have at least 1 cancer facility , they also tended to have lower total numbers of hospitals and NCORP sites . Figure 2, A and B shows that counties with the highest proportions of African Americans are in the South, where most counties are without any cancer facility.

Geographic distribution of the African American population, cancer facilities, and prostate cancer trials. A) The distribution of the percentage of the African American individuals in the population is shown on the US map with lines indicating US counties. B) The distribution of cancer facilities, as either no cancer-related facilities or having at least 1 cancer-related facility, is shown. C) The distribution of prostate cancer clinical trials between 2008 and 2015 is shown.

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