Beta Adrenergic Receptor Blockade as a Novel Therapy for Patients With Adenocarcinoma of the Pros… (NCT02944201) | Clinical Trial Compass
UnknownPhase 2
Beta Adrenergic Receptor Blockade as a Novel Therapy for Patients With Adenocarcinoma of the Prostate
United States22 participantsStarted 2017-04-01
Plain-language summary
This will be a single arm, window of opportunity study in men with treatment-naïve prostate cancer who will proceed to prostatectomy. Men will be treated with carvedilol prior to undergoing prostatectomy.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. The patient must be able to provide study-specific informed consent prior to study entry.
✓. Age ≥ 18
✓. ECOG Performance Status 0-1
✓. Pathologically proven diagnosis of prostate adenocarcinoma diagnosed by prostate biopsy with archival biopsy tissue available for analysis. The amount of cancer tissue present must be sufficient for analysis.
✓. Prostate adenocarcinoma classified as intermediate or high-risk as defined by one or more of the following criteria: PSA \>10 ng/ml, Gleason score ≥7, or tumor stage ≥T2b
✓. Patients must have no evidence of metastatic disease (including clinically negative pelvic lymph nodes) as established by imaging (CT or MRI of the pelvis and a bone scan) within 60 days prior to registration. Equivocal bone scan findings are allowed if plain film x-rays are negative for metastasis.
✓. The patient and the attending urologist have decided to proceed with prostatectomy
✓. Lab values meeting the following criteria
Exclusion criteria
✕. Patients with low risk prostate adenocarcinoma as defined by meeting all three of the following criteria: Gleason score ≤6, PSA \<10 and tumor stage ≤T2b
✕0. The presence of metastatic disease including to pelvic lymph nodes
✕1. Use of any beta-blocker at the time of diagnostic biopsy for prostate cancer or use of any beta-blocker at the time of screening. If the investigator does not believe that carvedilol can be safely added to the patients existing antihypertensive regimen, then the patient is not eligible for this study.
What they're measuring
1
Change in Biomarkers in Prostate Biopsy Compared to Prostatectomy Tissues
✕2. Prior therapy for prostate cancer including radiation therapy (external beam or brachytherapy), surgery, high-intensity focused ultrasound (HIFU), cryotherapy, previous hormonal therapy with androgen deprivation therapy by bilateral orchiectomy or LHRH analogues (e.g. leuprolide, goserelin, triptorelin, degarelix), antiandrogens, ketoconazole, abiraterone or chemotherapy (for prostate cancer, chemotherapy in the past for other indications is allowed).
✕3. Treatment with any investigational agent within 30 days prior to being registered for protocol therapy.
✕4. No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least 5 years.
✕5. Inability to take oral medication
✕6. Hypotension (systolic blood pressure \<100 mm Hg or diastolic blood pressure \<50 mm Hg) or bradycardia (pulse \<55 beats/min) at screening. For patients with a functioning pacemaker, bradycardia is not an exclusion.