motexafin gadolinium for Prostate Cancer

1
Effectiveness
1
Safety
Hospital of the University of Pennsylvania, Philadelphia, PA
Prostate Cancer+1 More
motexafin gadolinium - Other
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

This study is evaluating whether a series of tests can help find prostate cancer in men who have been diagnosed with prostate cancer.

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Eligible Conditions

  • Prostate Cancer
  • Prostatic Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether motexafin gadolinium will improve 1 primary outcome and 2 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of 2 to 14 Days.

2 to 14 Days
Comparison between T1-dependent or T1-independent methods for gadolinium quantification produce differing values for the RC for Ktrans
Repeatability assessment of DCE-MRI metrics Ktrans and blood-normalized initial area under the gadolinium curve (IAUGC90bn) and the DWI metric D(t)
Test-retest performance, assessed by the RC of Ktrans, IAUGC90bn, and D(t), and measured by median pixel values of the prostate tumor

Trial Safety

Safety Estimate

1 of 3

Side Effects for

Radiation and Motexafin Gadolinium
Lymphocyte count decreased
11%
Alanine aminotransferase increased
10%
Hypertension
8%
Hypophosphatemia
5%
Peripheral motor neuropathy
5%
Weight gain
5%
Palmar-plantar erythrodysesthesia syndrome
3%
Otitis media
3%
Headache
3%
Hydrocephalus
3%
White blood cell decreased
3%
Rash maculo-papular
3%
Anorexia
3%
Ataxia
3%
Hypermagnesemia
3%
Hypokalemia
3%
Hyperglycemia
3%
Hypoalbuminemia
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Fever
3%
Infections and infestations - Other, specify
3%
Dyspnea
2%
Diarrhea
2%
Pain
2%
Vomiting
2%
Hypocalcemia
2%
Neutrophil count decreased
2%
Upper respiratory infection
2%
Hypotension
2%
Anaphylaxis
2%
Dysphasia
2%
Alopecia
2%
Skin infection
2%
Alkaline phosphatase increased
2%
Catheter related infection
2%
Mucositis oral
2%
Abducens nerve disorder
2%
Extraocular muscle paresis
2%
Hypoxia
2%
Allergic rhinitis
2%
Dysphagia
2%
Bladder infection
2%
Cushingoid
2%
Constipation
2%
Facial nerve disorder
2%
External ear inflammation
2%
Fatigue
2%
Glossopharyngeal nerve disorder
2%
Hypoglycemia
2%
Hyponatremia
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Urine discoloration
2%
Hyperuricemia
2%
Irritability
2%
Weight loss
2%
Aspartate aminotransferase increased
2%
Encephalopathy
2%
Apnea
2%
Pruritus
2%
Ileus
2%
Lung infection
2%
Allergic reaction
2%
This histogram enumerates side effects from a completed 2010 Phase 2 trial (NCT00387790) in the Radiation and Motexafin Gadolinium ARM group. Side effects include: Lymphocyte count decreased with 11%, Alanine aminotransferase increased with 10%, Hypertension with 8%, Hypophosphatemia with 5%, Peripheral motor neuropathy with 5%.

Trial Design

2 Treatment Groups

Control
Repeatability Assessment

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Motexafin Gadolinium is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Repeatability Assessment
Other
Gadolinium motexafin gadolinium All participants will undergo two consecutive DCE-MRI and DWI scans per same imaging parameters and subsequent comparison for repeatability.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 to 14 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 to 14 days for reporting.

Closest Location

Hospital of the University of Pennsylvania - Philadelphia, PA

Eligibility Criteria

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

Mark “yes” if the following statements are true for you:
are considered a high-risk feature If three or more cores in the same prostate region are positive for prostate cancer, the feature is considered high-risk. show original
A Gleason score of 7 or higher is associated with a cancer burden. show original
prostate-specific antigen is a protein that is produced by the prostate gland show original
The patient was able to tolerate the MRI scan required by the protocol, which was performed at an ACRIN-qualified facility and scanner. show original
Some people with severe claustrophobia don't get relief from oral anxiolytics, which is the standard practice in institutions. show original
The presence of metallic objects or implanted medical devices in the body can make a person ineligible for an MRI scan show original
, and major organ dysfunction, as determined by the presence of 1 or more of the following: altered mental status, oliguria, respiratory failure, hepatic failure, or and arterial hypotension requiring intervention Renal failure, as determined by glomerular filtration rate (GFR) < 30 mL/min based on a serum creatinine level obtained within 48 hours prior to enrollment, and major organ dysfunction, as determined by the presence of 1 or more of the following: abnormal mental status, oliguria, respiratory failure, hepatic failure, or and arterial hypotension requiring intervention. show original
The text is talking about how a prostate adenocarcinoma can be diagnosed by a transrectal ultrasound (TRUS)-guided biopsy show original
is classified as high-risk A high-risk core is one that has a cancer burden of at least 50% and a tumor length of at least 5 mm. show original
, were independently associated with an increased risk of prostate cancer death show original

Patient Q&A Section

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

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

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The data indicated that between 2 in 10 and 2 in 20 men undergo a PSA test each year and that 1 in 10 men will be diagnosed with prostate cancer.

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How serious can prostate cancer be?

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Age is the leading causal factor for death from prostate cancer, while other risk factors of mortality were diabetes mellitus, cardiovascular disease, lung cancer, and Parkinson's disease.

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Who should consider clinical trials for prostate cancer?

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To improve patient selection for clinical trials for prostate cancer, investigators should tailor trials to maximize the detection of patients whose tumors have a low proliferation rate.

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What causes prostate cancer?

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Prostate cancer is uncommon among Caucasians, but it occurs commonly among Americans of African descent. In this group, risk is positively correlated with socioeconomic status. This has implications for the design of prostate cancer screening studies.

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Can prostate cancer be cured?

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Given the significant effects of metastatic disease, the treatment of localized prostate cancer using the usual therapeutic approaches must be encouraged. The ability to define an effective and effective treatment is lacking for metastatic prostate cancer. A combination of androgen ablation and chemotherapy may prevent progression to androgen independent disease. We discuss the likelihood of cures for patients at various clinical stages with metastatic disease.

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What are common treatments for prostate cancer?

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Prostate cancer is commonly treated through a variety of therapeutic modalities. For localized and locally advanced cases, radiation therapy and surgery are the treatment of choice. Prostate-specific antigen testing is used to determine the prognosis of a case and if further treatment is indicated. When surgery is required then radical prostatectomy is the standard of care, while radiation treatments may be used in patients with localized disease.

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What are the signs of prostate cancer?

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Symptoms of prostate cancer are present in the general population. If signs of prostate cancer are present the first step is to conduct a digital rectal examination (DRE) with digital examination of the penis and/or scrotum, especially if there is history of symptoms.

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What is prostate cancer?

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Prostate tumor has been classified as malignant or non-malignant in accordance with its growth rate, malignancy, metastatic potential and other pathological factors, or as benign or premalignant in accordance with its benign growth rate, and asymptomatic in accordance with low serum PSA level. Prostate cancer is the second leading cause of death in men. It is estimated to cause 7,590 deaths in the United States in 2014.\n

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What is the latest research for prostate cancer?

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In this research paper, the new research regarding prostate cancer is reviewed. Specifically, the research papers related to prostate cancer have not change their findings since the discovery of the PSA test. The PSA testing as a screening test for prostate cancer was developed and introduced in the 1980s. The PSA test is the most commonly used blood test for prostate cancer and has been helpful in detecting prostate cancer, however, its use has also introduced problematic consequences to millions of men. The PSA test may not be as accurate as it was before as the number of PSA tests performed increased. In recent years, the PSA test has also been introduced in the digital rectal examinations as an aid in the detection of prostate cancer lesions.

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What does motexafin gadolinium usually treat?

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The indication of motexafin gadolinium treatment is limited to a group of patients with recurrent or progressive metastatic disease after prior chemotherapy and radiotherapy. The treatment with motexafin gadolinium is an option in patients with nonmetastases and locally advanced prostate cancer when the PSA is < 70 ng/ml.

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What is motexafin gadolinium?

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The novel imaging agent, motexafin gadolinium, provides a noninvasive alternative to MRI for the assessment of metastatic disease in patients with known or suspected prostate cancer. The low incidence of adverse events may make it a useful adjunct to MRI in the preoperative staging of prostate cancer.

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How does motexafin gadolinium work?

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The current results suggest that the mechanism underlying the efficacy of motexafin gadolinium on prostate cancers may be an enhancement of cell death through a mitochondria-mediated apoptosis, and a possible inhibition of angiogenesis.

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