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Usually, the male hormone testosterone makes prostate cancer cells grow. Lowering testosterone usually stops the growth of prostate cancer. However, after a period of time without testosterone, prostate cancer cells learn to grow again.
You are able to join this trial because your prostate cancer is growing even though you have very low levels of testosterone. Studies have shown that high doses of testosterone, in this situation, can cause prostate cancer cells to stop growing.
The investigators did a study several years ago in which the investigators gave high doses of testosterone to patients such as yourself. The investigators showed that giving testosterone in this situation was safe. The investigators also showed that the investigators could, in some cases, make the PSA go down using high-dose testosterone.
The investigators believe that they can improve this type of treatment by combining testosterone with another drug called dutasteride. Dutasteride is another type of hormone. It should make testosterone levels rise. The investigators believe that combination of dutasteride and testosterone will be more a more powerful regimen against your cancer than testosterone alone.
Enrollment
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Inclusion criteria
Patients should have histologically confirmed castration-resistant metastatic prostate cancer with evidence of disease progression. Patients must have been in a castrate state either by orchiectomy or by GnRH analogues for a minimum of one year. In detail, they should meet all of the following criteria:
Adult male > or = to 18 years of age
Histologically confirmed prostate cancer, currently with progressive disease, defined as rising PSA (50% or more increase to a level of 2 ng/mL or more, based on at least 3 PSA determinations obtained at least 1 weeks apart), or 2 new osseous lesions by bone scan, soft tissue disease progression by RECIST 1.1 criteria , or the appearance of new sites of disease (by MRI/CT).
Evidence of metastatic disease, documented within 4 weeks prior to dutasteride treatment initiation, based on a:
Serum PSA ≥ 2 ng/mL within 4 weeks prior to dutasteride treatment initiation in order to register to the protocol
Normal organ function with acceptable initial laboratory values documented within 4 weeks prior to dutasteride treatment initiation:
Karnofsky performance status > or = to 70%
Willingness to undergo serial blood draws for the purpose of measuring CTCs and other biomarkers. MSKCC patients will need to agree to participate in MSKCC protocol 90-040 Molecular studies and clinical correlations in human prostate cancer [PI: Scher]. Also, MSKCC patients will undergo serial imaging by FDHT and FDG PET scans, under protocol 00-095 [18f]-fluoro-2-deoxy-D-glucose and [18f]-dihydro-testosterone PET imaging in patients with progressive prostate cancer (PI: Morris), depending on tracer and scanner time availability. If the study is opened in other centers outside MSKCC, those centers will be exempt from procedures linked to the MSKCC Protocol # 00-095.
ADT treatment for at least 12 months prior to study entry with serum testosterone < 50 ng/dL.
Ability to understand and willingness to sign a written informed consent document
Exclusion criteria
Patients meeting any of the following criteria will not be eligible for study entry:
Evidence of small-cell or neuroendocrine pathologic features
Uncontrolled urinary obstruction
Osseous metastatic disease with imminent risk (at the discretion of the treating physician) of pathologic fracture or cord compression (in patients with known spinal metastasis raising concern for cord compression, MRI of the spine should be performed to rule out epidural disease)
Any situation where, at the discretion of the treating physician, a potential "tumor flare" would be life-threatening
Sleep apnea (unless under good control with current treatment)
Polycythemia vera
History of allergic reactions attributed to compounds of similar chemical or biological composition to dutasteride
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would compromise compliance with study requirements
Currently active secondary malignancy (as determined by the treating physician) other than non-melanoma skin cancer
Use of the following medications will be prohibited during the study:
Evidence of epidural disease by MRI
Primary purpose
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6 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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