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Monoclonal Antibody Therapy For Prostate Cancer

Prostate Cancer Targeted Therapy: Ar

Monoclonal Antibodies For Cancer Treatment and Imaging

Androgens play a major role in the development, growth, and maintenance of the prostate. As with normal prostate development, primary prostate cancers are largely dependent on androgens for growth and survival. Androgens exert their effects via the intracellular androgen receptor , a ligand-dependent transcriptional activator. In fact, androgens and AR represent the very first class of unique targets for therapies tailored for prostate cancers. MDV3100 is an oral androgen receptor antagonist in development for the treatment of early-stage and advanced prostate cancer. It directly inhibits AR by binding the receptor irreversibly. This interaction impairs AR nuclear translocation, DNA binding, and recruitment of co-activators

What Are Targeted Cancer Therapies

Targeted cancer therapies are drugs or other substances that block the growth and spread of cancer by interfering with specific molecules that are involved in the growth, progression, and spread of cancer. Targeted cancer therapies are sometimes called “molecularly targeted drugs,” “molecularly targeted therapies,” “precision medicines,” or similar names.

Targeted therapies differ from standard chemotherapy in several ways:

  • Targeted therapies act on specific molecular targets that are associated with cancer, whereas most standard chemotherapies act on all rapidly dividing normal and cancerous cells.
  • Targeted therapies are deliberately chosen or designed to interact with their target, whereas many standard chemotherapies were identified because they kill cells.
  • Targeted therapies are often cytostatic , whereas standard chemotherapy agents are cytotoxic .

Targeted therapies are currently the focus of much anticancer drug development. They are a cornerstone of precision medicine, a form of medicine that uses information about a persons genes and proteins to prevent, diagnose, and treat disease.

Many targeted cancer therapies have been approved by the Food and Drug Administration to treat specific types of cancer. Others are being studied in clinical trials , and many more are in preclinical testing .

Enzalutamide With Or Without Abiraterone And Prednisone In Treating Patients With Castration

Sorry, in progress, not accepting new patients

This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone, and prednisone in treating patients with castration-resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens made by the body.

San Francisco, California

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Study Of Azd5305 As Monotherapy And In Combination With Anti

Sorry, not currently recruiting here

This research is designed to determine if experimental treatment with PARP inhibitor, AZD5305, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.

San Francisco, California and other locations

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Call Joe Hall at 844-863-5518 to learn more about his prostate cancer journey. Joes an 11-year prostate cancer survivor and has talked to thousands of men about their prostate cancer.

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Recommended Reading: Bipolar Androgen Therapy Prostate Cancer

Radiologically Guided Biopsies Of Mcrpc

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The purpose of this study is to better understand how cancer treatment may affect cancer cells. The research will involve genetic, molecular, cellular, and immunologic experiments using blood and tumor specimens. It is hoped that the information gained from these studies will lead to a greater understanding of castrate-resistant prostate cancer and potentially, improvements in cancer treatment. This is a tissue collection protocol requiring image-guided biopsies of metastatic, castration-resistant prostate cancer . The investigators will focus on enrolling patients with metastatic CRPC who have progressed while receiving novel AR-targeted therapeutics such as abiraterone and enzalutamide. This population of patients was selected because resistance develops relatively rapidly following potent inhibitors of AR activity and the mechanisms of resistance have to be better understood. Without comprehensive analysis of mCRPC tumor, the investigators will never gain a full understanding of the biology driving resistance in human disease and developing rational co-targeting approaches will not be possible.

San Francisco, California and other locations

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

open to eligible males ages 18-100

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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Combination Of Bipolar Androgen Therapy And Nivolumab

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Single arm, multicenter, open-label Phase II study of the effects of parenteral testosterone in combination with nivolumab in men with metastatic castration-resistant prostate cancer who previously progressed on at least one novel androgen-receptor targeted therapy . Up to one taxane agent is permitted.

San Francisco, California

Safety Pharmacokinetic And Proof

Monoclonal Antibodies: Making Cancer a Target

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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

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What Are The Limitations Of Targeted Cancer Therapies

Targeted therapies do have some limitations. One is that cancer cells can become resistant to them. Resistance can occur in two ways: the target itself changes through mutation so that the targeted therapy no longer interacts well with it, and/or the tumor finds a new pathway to achieve tumor growth that does not depend on the target.

For this reason, targeted therapies may work best in combination. For example, a recent study found that using two therapies that target different parts of the cell signaling pathway that is altered in melanoma by the BRAF V600E mutation slowed the development of resistance and disease progression to a greater extent than using just one targeted therapy .

Another approach is to use a targeted therapy in combination with one or more traditional chemotherapy drugs. For example, the targeted therapy trastuzumab has been used in combination with docetaxel, a traditional chemotherapy drug, to treat women with metastatic breast cancer that overexpresses the protein HER2/neu.

What Are Monoclonal Antibodies

In immunotherapy, monoclonal antibodies may be used to block signals that cancer cells send to evade the immune system. Monoclonal antibodies are much more commonly used in targeted cancer therapy, where theyre designed to attach to antigens found on cancer cells. Monoclonal antibodies used in targeted therapy include:

  • Naked monoclonal antibodies, engineered to stop cancer cell growth or cause the cancer cells to self-destruct
  • Conjugated monoclonal antibodies, designed to carry chemotherapeutic agents or radioactive substances to tumor cells to cause cell death
  • Bispecific monoclonal antibodies, two monoclonal antibodies that can attach to two different proteins at the same time

Monoclonal antibody treatments have been around for 35 years. The U.S. Food and Drug Administration has approved about 100 monoclonal antibodies for therapies, with about a third of those treating different types of cancer. Another 570 are being studied, with roughly 70 percent of those designed as cancer treatments.

Ankur R. Parikh, DO, Medical Director of Precision Medicine at Cancer Treatment Centers of America® , says each type of monoclonal antibody is narrowly designed to attach to a specific antigen on a cell. Its a specific molecule that were using that targets the actual cancer itself and so, therefore, gives patients potentially better responses than just standard chemotherapy, which kills anything, good and bad, Dr. Parikh says.

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Treatment With Nivolumab And Ipilimumab Or Nivolumab Alone According To The Percentage Of Tumoral Cd8 Cells In Advanced Metastatic Cancer

open to eligible people ages 18 years and up

This is an open-label, exploratory study to evaluate nivolumab with or without ipilimumab based on percentage of tumoral CD8 cells at the time of treatment in participants with varying advanced solid tumors. Participants who have a tumor with ⥠15% CD8 cells will receive nivolumab monotherapy, and participants who have a tumor with < 15% CD8 cells will receive ipilimumab in combination with nivolumab.

San Francisco, California

For46 In Combination With Enzalutamide In Patients With Metastatic Castration Resistant Prostate Cancer

(PDF) Anti

Sorry, not yet accepting patients

This is a Phase 1b/2 study evaluating FOR46 in combination with enzalutamide in patients with metastatic castration resistant prostate cancer after prior progression on abiraterone. FOR46 is designed to target and bind to CD46, a transmembrane cellular protein expressed at moderate or high levels in numerous cancer types. The investigators hypothesize that the combination of FOR46 plus enzalutamide will achieve a clinically significant composite response rate with sufficient durability of response in mCRPC patients.

San Francisco, California

Also Check: What Are The Screening Tests For Prostate Cancer

How Are Targeted Therapies Developed

Once a candidate target has been identified, the next step is to develop a therapy that affects the target in a way that interferes with its ability to promote cancer cell growth or survival. For example, a targeted therapy could reduce the activity of the target or prevent it from binding to a receptor that it normally activates, among other possible mechanisms.

Most targeted therapies are either small molecules or monoclonal antibodies. Small-molecule compounds are typically developed for targets that are located inside the cell because such agents are able to enter cells relatively easily. Monoclonal antibodies are relatively large and generally cannot enter cells, so they are used only for targets that are outside cells or on the cell surface.

Candidate small molecules are usually identified in what are known as “high-throughput screens,” in which the effects of thousands of test compounds on a specific target protein are examined. Compounds that affect the target are then chemically modified to produce numerous closely related versions of the lead compound. These related compounds are then tested to determine which are most effective and have the fewest effects on nontarget molecules.

Monoclonal antibodies are developed by injecting animals with purified target proteins, causing the animals to make many different types of antibodies against the target. These antibodies are then tested to find the ones that bind best to the target without binding to nontarget proteins.

How Is It Determined Whether A Patient Is A Candidate For Targeted Therapy

For some types of cancer, most patients with that cancer will have an appropriate target for a particular targeted therapy and, thus, will be candidates to be treated with that therapy. CML is an example: most patients have the BCR-ABL fusion gene. For other cancer types, however, a patients tumor tissue must be tested to determine whether or not an appropriate target is present. The use of a targeted therapy may be restricted to patients whose tumor has a specific genemutation that codes for the target patients who do not have the mutation would not be candidates because the therapy would have nothing to target.

Sometimes, a patient is a candidate for a targeted therapy only if he or she meets specific criteria . These criteria are set by the FDA when it approves a specific targeted therapy.

Also Check: What Age Do Males Get Prostate Cancer

A Phase 1 Study Of Pegilodecakin In Participants With Advanced Solid Tumors

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This is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of pegilodecakin in participants with advanced solid tumors, dosed daily subcutaneously as a monotherapy or in combination with chemotherapy or immunotherapy.

San Francisco, California and other locations

Platform Study For Prostate Researching Translational Endpoints Correlated To Response To Inform Use Of Novel Combinations

Using Monoclonal Antibodies to Target Cancer Cells

open to eligible males ages 18 years and up

This study is designed to evaluate multiple clinical hypotheses and mechanistically-defined combinations to evaluate the safety and efficacy of immunotherapy combinations in participants with mCRPC who have received prior secondary androgen receptor signaling inhibitor therapy .

San Francisco, California

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What Are The Side Effects Of Targeted Cancer Therapies

Scientists had expected that targeted cancer therapies would be less toxic than traditional chemotherapy drugs because cancer cells are more dependent on the targets than are normal cells. However, targeted cancer therapies can have substantial side effects.

The most common side effects seen with targeted therapies are diarrhea and liver problems, such as hepatitis and elevated liver enzymes. Other side effects seen with targeted therapies include:

  • Skin problems
  • Problems with blood clotting and wound healing
  • High blood pressure
  • Gastrointestinal perforation

Certain side effects of some targeted therapies have been linked to better patient outcomes. For example, patients who develop acneiform rash while being treated with the signal transduction inhibitorserlotinib or gefitinib , both of which target the epidermal growth factor receptor, have tended to respond better to these drugs than patients who do not develop the rash . Similarly, patients who develop high blood pressure while being treated with the angiogenesis inhibitorbevacizumab generally have had better outcomes .

The few targeted therapies that are approved for use in children can have different side effects in children than in adults, including immunosuppression and impaired sperm production .

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

Recommended Reading: Natural Products For Prostate Health

Apalutamide With Or Without Stereotactic Body Radiation Therapy In Treating Participants With Castration

open to eligible males ages 18 years and up

This phase II trial studies the how well apalutamide with or without stereotactic body radiation therapy work in treating participants with castration-resistant prostate cancer. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. 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. It is not yet known whether giving apalutamide with or without stereotactic body radiation therapy works better in treating participants with castration-resistant cancer.

San Francisco, California

Immunotherapy In Patients With Metastatic Cancers And Cdk12 Mutations

Monoclonal antibody in cancer therapy

open to eligible people ages 18 years and up

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 harboring loss of CDK12 function.

San Francisco, California

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How Are Targets For Targeted Cancer Therapies Identified

The development of targeted therapies requires the identification of good targetsthat is, targets that play a key role in cancer cell growth and survival.

One approach to identify potential targets is to compare the amounts of individual proteins in cancer cells with those in normal cells. Proteins that are present in cancer cells but not normal cells or that are more abundant in cancer cells would be potential targets, especially if they are known to be involved in cell growth or survival. An example of such a differentially expressed target is the human epidermal growth factor receptor 2protein . HER-2 is expressed at high levels on the surface of some cancer cells. Several targeted therapies are directed against HER-2, including trastuzumab , which is approved to treat certain breast and stomach cancers that overexpress HER-2.

Another approach to identify potential targets is to determine whether cancer cells produce mutant proteins that drive cancer progression. For example, the cell growth signaling protein BRAF is present in an altered form in many melanomas. Vemurafenib targets this mutant form of the BRAF protein and is approved to treat patients with inoperable or metastatic melanoma that contains this altered BRAF protein.

Prostate Radiation Therapy Or Short

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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens made by the body. It is not yet known which regimen of radiation therapy with or without androgen-deprivation therapy is more effective for prostate cancer.

PURPOSE: This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer.

San Francisco, California

Recommended Reading: What Causes Prostate Psa Levels To Rise

Promote: Identifying Predictive Markers Of Response For Genitourinary Cancer

open to eligible males ages 18 years and up

This is a tissue and blood collection protocol requiring image-guided biopsies of metastatic prostate cancer and other genitourinary malignancies including renal cell carcinoma and urothelial carcinoma. Whenever possible, a new bone lesion or new/progressing soft tissue lesion will be chosen for biopsy as opposed to radiographically stable lesion. Patients will be enrolled in into one of several parallel cohorts based upon disease status or type and the planned systemic therapy following baseline tumor biopsy: Androgen signaling inhibition, Immunotherapy, Radiotherapy, Targeted Therapy/Investigational therapeutic, DNA damage response pathway, Aggressive variant disease, Castration-sensitive ADT naïve and ADT < 3 months), or Castration-sensitive pre-treated with sub-optimal PSA nadir > 0.2 ng/ml, metastatic renal cell carcinoma and metastatic and urothelial carcinoma.

San Francisco, California

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