CLINICAL TRIAL

Daratumumab for Adenocarcinoma, Prostate

Locally Advanced
Metastatic
Waitlist Available · 18+ · Male · Houston, TX

Daratumumab or FMS Inhibitor JNJ-40346527 Before Surgery in Treating Patients With High-Risk, Resectable Localized or Locally Advanced Prostate Cancer

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About the trial for Adenocarcinoma, Prostate

Eligible Conditions
Adenocarcinoma, Prostate · Stage III Prostate Cancer AJCC v8 · Testosterone Greater Than or Equal to 150 ng/dL · Stage IIIB Prostate Cancer AJCC v8 · Stage IIIA Prostate Cancer AJCC v8 · Prostatic Neoplasms · Stage IIIC Prostate Cancer AJCC v8

Treatment Groups

This trial involves 2 different treatments. Daratumumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Daratumumab
BIOLOGICAL
+
Radical Prostatectomy
PROCEDURE
Experimental Group 2
FMS Inhibitor JNJ-40346527
DRUG
+
Radical Prostatectomy
PROCEDURE

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
FDA approved
Radical Prostatectomy
2005
Completed Phase 2
~650

Eligibility

This trial is for male patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Consent to MD Anderson laboratory protocol PA13-0291.
Histological documentation of adenocarcinoma of the prostate reviewed at MD Anderson Cancer Center. Patients with small cell, neuroendocrine, or transitional cell carcinomas are not eligible.
Patients with high-risk prostate cancer (at least 1 core with Gleason sum >= 8) must have at least three core biopsies involved with cancer (a minimum of 6 core biopsies, must be obtained at baseline). A prostate biopsy within 3 months from screening is allowed for entry requirements.
No evidence of metastatic disease as documented by technetium-99m (99mTc) bone scan and by computed tomography (CT) or magnetic resonance imaging (MRI) scans.
Eugonadal state (serum testosterone > 150 ng/dL).
Localized or locally advanced disease deemed by the surgeon to be resectable. Patients must be appropriate candidates for radical prostatectomy plus pelvic lymph node dissection.
No prior treatment for prostate cancer including prior surgery (excluding transurethral resection of the prostate [TURP]), cryoablation, pelvic lymph node dissection, radiation therapy, hormonal therapy or chemotherapy.
To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. If the subject is engaged in sexual activity with a woman of childbearing potential, a condom is required along with another effective contraceptive method consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies and their partners. Donation of sperm is not allowed while on study drug and for 3 months following the last dose of study drug.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of 0 or 1.
AT SCREENING: Hemoglobin within institutional normal limits. Administration of growth factors or blood transfusions will not be allowed to confirm eligibility.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to week 18
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to week 18
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to week 18.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Daratumumab will improve 1 primary outcome and 3 secondary outcomes in patients with Adenocarcinoma, Prostate. Measurement will happen over the course of Baseline up to week 18.

Immune changes in blood
BASELINE UP TO WEEK 18
BASELINE UP TO WEEK 18
Immune changes in tumor tissue
BASELINE UP TO WEEK 18
BASELINE UP TO WEEK 18
Pathological complete response (CR)
UP TO WEEK 18
Pathologic response will be measured from the surgical specimen. Pathologic CR is defined as the absence of residual tumor in the radical prostatectomy specimen (i.e., pT0).
UP TO WEEK 18
Incidence of adverse events
UP TO WEEK 18
Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Will be recorded for all patients, recording name, grade, start and end dates, attribution to study drug, and whether the event was alleviated or controlled with relevant appropriate care similar to Phase I trials.
UP TO WEEK 18

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes adenocarcinoma, prostate?

Adenocarcinoma of the prostate can be caused by environmental factors or genetic predisposition and may be influenced by the age of onset. Prostate cancer is usually associated with BPH and the use of drugs such as finasteride. In most cases, the tumors are slow to develop.

Anonymous Patient Answer

How many people get adenocarcinoma, prostate a year in the United States?

There is a decline in the number of new cases of adenocarcinoma, prostate a year in the overall population of the US, particularly in those below 65 years of age. The decrease was observed from 1999 through 2000, and persists to 2008. Given the lack of changes in the prevalence of adenocarcinoma, prostate a year, this implies that a large proportion of these new cases were diagnosed with existing cases of adenocarcinoma, prostate.

Anonymous Patient Answer

What is adenocarcinoma, prostate?

Adenocarcinoma of the prostate is a deadly but curable disease. It is a type of cancer that occurs where the growth of gland-like cells in the prostate occur. Clinically significant disease is often seen in men aged 60 to 80 years.

Anonymous Patient Answer

What are common treatments for adenocarcinoma, prostate?

There is no cure for adenocarcinoma, prostate. So treatment is always tailored to a patient's needs and is highly dependent on the nature and cause of the disease as well as individual patient characteristics. Patients often are prescribed a course of treatment for several months and are likely to change treatment during the course of treatment. The specific treatment is a tailored response to how the patient presents and their disease, the course of treatment, and the individual patient's tolerances, expectations and preferences.

Anonymous Patient Answer

Can adenocarcinoma, prostate be cured?

Adenocarcinoma, prostate is a challenging disease in which many treatments have not been proven efficient and no curative treatment has been devised so far. This paper discusses treatment options and emphasizes that a cure on a macro scale is probably unattainable. However, the micro details on how tumor cells invade adjacent tissues are a promising target of new treatment modalities.

Anonymous Patient Answer

What are the signs of adenocarcinoma, prostate?

The symptoms which can be caused by adenocarcinoma, prostate include pelvic pain, hematuria, hematochezia, dysuria, weight gain, pelvic mass, and vaginal bleeding. The symptoms which will be caused by adenocarcinoma, prostate include abdominal pain, hemo-chromia, fever, constipation, and malaise. The symptoms which will be caused by adenocarcinoma, prostate include backache, chest pain and cough. The symptoms which will be caused by adenocarcinoma, prostate include loss of appetite and weight loss.

Anonymous Patient Answer

What is the primary cause of adenocarcinoma, prostate?

The primary cause of adenocarcinoma, prostate, is not obvious on paper unless you have examined a case of adenocarcinoma of the prostate and found there are some features that are different from the usual cause. This article describes those features.

Anonymous Patient Answer

What are the latest developments in daratumumab for therapeutic use?

Daratumumab demonstrates promising antitumor activity in a variety of solid tumor models as a monotherapy, combination therapy, and with other agents, especially in combination with radiation and androgen deprivation therapy. Data from a recent study indicate that further investigations are warranted to determine its optimal use in the treatment of patients affected by sarcomas and lymphomas.

Anonymous Patient Answer

What is the average age someone gets adenocarcinoma, prostate?

Adenocarcinoma occurred most frequently in men younger than 65 years, an age which is generally thought to represent men who actively participate in the fitness boom of the 1970s, thus being exposed to environmental carcinogens. A greater percentage of men presenting with prostate cancer were older.

Anonymous Patient Answer

Is daratumumab safe for people?

Daratumumab was generally safe in this population. Few infections, leukopenia, and thrombotic events were observed. Because of the lower incidence of myelosuppression, daratumumab may be effective for patients who are already getting and may have to continue immunosuppressant therapy.

Anonymous Patient Answer

What are the chances of developing adenocarcinoma, prostate?

The odds of developing prostate cancer increased 1.6-fold as the age at the time of first menses decreased by 5 years. However, an individual's risk of developing adenocarcinoma was low. Although prostate cancers were more common in the first-degree relatives of men with prostate cancer than in the controls (odds ratio, 1.95; p < 0.01), this increase was offset by a very low incidence of high-risk, Stage T3 adenocarcinomas (incidence ratio, 0.12; p < 0.01).

Anonymous Patient Answer

Does daratumumab improve quality of life for those with adenocarcinoma, prostate?

Daratumumab for 4 weeks is safe for most patients with mCRC and improves QOL. The addition of 4 weeks of darbepoetin and daratumumab resulted in worse QOL in a group of patients with the worst baseline QOL, indicating darbepoetin may be a better choice than daratumumab.

Anonymous Patient Answer
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