This trial is evaluating whether Neratinib will improve 1 primary outcome and 6 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of 84 days.
This trial requires 14 total participants across 2 different treatment groups
This trial involves 2 different treatments. Neratinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
The cause of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) remains currently unknown. Risk factors appear to include age, ethnicity, a family history of the disease, high prostate-specific antigen (PSA) levels, and exposure to radiation. The role of genetics remains unclear. Recent advances in molecular and cellular biology suggest a possible pathogenic mechanism whereby alterations in the DNA repair machinery lead to the accumulation of mutations and thus an increased likelihood of developing prostatic tumours.
The cure rate for cancers of the prostate is extremely high, while the cure rate for cancers of other sites is significantly lower. However, the vast majority of men do not have evidence of overt metastases or circulating tumors during follow-up after definitive therapy. Therefore, the possibility that cancers may spontaneously regress cannot be excluded. If spontaneous remission is possible, it does not change the high cure rate; in some studies, more than 90% of men were obviously cured of both prostate and of any cancer. Men at high risk of developing prostate cancer, and of whose disease we have good evidence of complete and persistent treatment compliance, can be cured. When surgery can be successful in removing the benign prostate gland, a cure certainly is possible.
The treatments of prostate cancer in this population are very complex. The standard of care for a prostate cancer patient involves radiotherapy and hormonal therapy. These modalities are often preceded by surgery and, rarely, local ablative therapies. The most common and the most expensive treatments involve radiation or androgen deprivation. The treatment most frequently offered to these patients is brachytherapy. On the other hand, treatment modalities are frequently changed on the basis of patients' response to treatments. Given that such treatments can be costly, complex, and sometimes with significant side effects, the current reimbursement for their use is variable across the United States. Furthermore, many patients are not provided with all of the above-mentioned treatment modalities in a single institution.
The majority of the men have had their prostate removed by prostatectomy. The pathology report typically contains the diagnosis of BPH or PCa, but is vague regarding whether it is localized or organ-confined disease. A biopsy that contains cancer has a probability of approximately 50 to 60%. Only 25% of the patients were diagnosed while still asymptomatic (60<or = PSA<10 ng/ml) – these cases may represent the most curable cases. The prostate tumour may be localised to the prostate but also metastasised to other organs and/or the lymph nodes. Only 15% are bilateral and only 3% have a low grade Gleason Score, i.e.
Recent findings suggest that: (1) elevated prostate specific antigen is a reliable indicator of prostate cancer and will provide a means of early detection, (2) serum digital rectal examination allows accurate detection of prostate cancer, and (3) clinical staging provides valuable information about prostate cancer.
In a recent study, findings suggests that it is time to begin to collect the national data needed to confirm our findings that a significant proportion of patients are diagnosed with clinically localized prostate cancer. This knowledge will give an insight to the use of imaging to diagnose prostate cancer earlier and improve outcomes.
Patients with a cT grade 3 or 4 prostate cancer have a low likelihood of nodal metastasis following RP. Tumor location remains the most significant predictor of nodal metastases following RP.
Neratinib demonstrated a significantly greater than placebo effect and was well tolerated over an extension phase I/III study, with more patients progressing to the next phase and having higher rates of progressive disease. Data from a recent study are consistent with our Phase II data and confirms the clinical effectiveness of RT+neratinib in patients with early stage or'slow growing' NSCLC.
Given the frequent co-existence of BPH and [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) in both spouses of patients carrying and of patients with prostate cancer, and a strong association with relatives in prostate cancer, we suggest that a BPH/prostate cancer co-adoption model can be a powerful concept to explain this relationship.
Neratinib has proven to be safe in the treatment of adult patients with metastatic disease. Side effects encountered in this population have included fatigue, dyspnea, nausea, pain, and diarrhea. The majority of patients discontinued treatment due to either pain or fatigue, however, the most common side effect was abnormal liver function. Neratinib has not been found to significantly worsen the condition of patients who previously received cisplatin-based chemotherapy.
Treatment of patients with advanced or metastatic prostate cancer with neratinib resulted in improved QOL compared to placebo among patients having been previously treated for this disease.
This article offers the latest research on prostate cancer to help physicians and patients to understand and diagnose this disease. It also helps us to select the most appropriate treatment options, which is crucial in reducing the likelihood of suffering prostate cancer-related deaths.