Clinical Trials

8 studies in Prostate Cancer

1. Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer Jacksonville, FL View Summary
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   Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer

   Location:

   Jacksonville, FL Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES:
   
   - Compare the 5-year freedom from progression in patients with intermediate-risk prostate cancer treated with interstitial brachytherapy with or without external beam radiotherapy (EBRT).
   
   - Compare biochemical (i.e., prostate-specific antigen) failure, biochemical failure by the Phoenix definition, disease-specific survival, local progression, and distant metastases in patients treated with these regimens.
   
   - Compare morbidity and quality of life of patients treated with these regimens.
   
   - Determine the feasibility of collecting Medicare data in a large RTOG prostate cancer clinical trial for cost effectiveness and cost utility analysis of combined treatment with interstitial brachytherapy and EBRT.
   
   - Prospectively collect diagnostic biopsy samples from these patients for future biomarker analyses.
   
   OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (T1c vs T2a or T2b), Gleason score (≤ 6 vs 7), prostate-specific antigen (< 10 ng/mL vs 10-20 ng/mL), and prior neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
   
   - Arm I: Patients undergo external beam radiotherapy 5 days a week for 5 weeks. Within 2-4 weeks of radiotherapy, patients undergo interstitial brachytherapy with iodine I 125 or palladium Pd 103 seeds.
   
   - Arm II: Patients undergo interstitial brachytherapy only, as in arm I. Quality of life is assessed at baseline, at 4, 12, and 24 months, and then annually for 3 years.
   
   After completion of study treatment, patients are followed at 3-5 weeks, at 4, 6, 9, and 12 months, every 6 months for 4 years, and then annually thereafter.

   NCT ID:

   NCT00063882

   IRB Number:

   58-04

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   Who can I contact for additional information about this study?

   Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   
   Jacksonville: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   

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2. Gene Therapy and Radioactive Iodine in Treating Patients With Locally Recurrent Prostate Cancer That Did Not Respond to External-Beam Radiation Therapy Rochester, MN View Summary
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   Gene Therapy and Radioactive Iodine in Treating Patients With Locally Recurrent Prostate Cancer That Did Not Respond to External-Beam Radiation Therapy

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES: Primary - To determine the safety and tolerance of Ad5CMV-NIS administered intraprostatically followed by radioiodine treatment in patients with locally recurrent adenocarcinoma of the prostate following external beam radiotherapy. - To determine the maximum tolerated dose of Ad5CMV-NIS in these patients. Secondary - To evaluate the PSA response rates, duration, and time to PSA progression in these patients. - To evaluate the immune response to Ad5CMV-NIS. OUTLINE: This is a dose-escalation study of Ad5CMV-NIS. Patients receive intraprostate Ad5CMV-NIS, via transperineal injection under anesthesia, on day 1. They receive dosimetry oral iodine I 123 on day 4 and undergo image studies periodically for the next 24 hours for measurement of radioiodine uptake. Patients receive therapeutic oral iodine I 131 on day 5. All patients with intact thyroid glands (i.e., not previously surgically removed or ablated) receive TSH suppressive doses of oral liothyronine sodium 3 times daily for 10 days prior and for 15 days post administration of iodine I 123. Blood samples are collected periodically for measurement of PSA, fT4, and TSH; and peripheral blood cells are monitored for evidence of virus DNA via quantitative reverse-transcriptase-PCR. After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 8 years. A transrectal tumor biopsy is to be performed at 3 months and 1 year post-treatment.

   NCT ID:

   NCT00788307

   IRB Number:

   06-009392

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   Who can I contact for additional information about this study?

   Rochester: Mayo Clinic Clinical Trials Office 507-538-7623
                       
   
   
   

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3. Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer Jacksonville, FL Scottsdale and Phoenix, AZ View Summary
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   Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer

   Location:

   Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES: Primary - Demonstrate an overall survival (OS) advantage in patients with intermediate-risk prostate cancer treated with dose-escalated radiotherapy (RT) with versus without short-term androgen-deprivation therapy (ADT). Secondary - Determine whether the addition of ADT to dose-escalated RT versus RT alone improves clinical failures, biochemical failure by the "nadir +2", freedom from failure, rate of salvage ADT, and prostate cancer-specific mortality in these patients. - Estimate the magnitude of benefit of ADT with respect to OS in patients treated with different RT modalities (i.e., external-beam radiation therapy alone vs low-dose rate brachytherapy boost vs high-dose rate brachytherapy boost). - Compare acute and late treatment adverse events of these regimens and correlate these events with the presence or absence of pre-existing comorbidity as documented by the Adult Comorbidity Evaluation 27 assessment. OUTLINE: This is a multicenter, dose-escalation study of radiotherapy. Patients are stratified according to number of risk factors (1 vs 2-3), comorbidity (ACE-27 grade ≥ 2 vs < 2), and radiotherapy (RT) modality (dose-escalated external-beam RT [EBRT] vs EBRT and low-dose rate brachytherapy boost vs EBRT and high-dose rate brachytherapy boost). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo EBRT* once daily on days 1-5 for about 9 weeks (44 treatments). Some patients instead receive EBRT with high-dose rate or low-dose rate brachytherapy implant on days 1-5 for about 5 weeks (25 treatments). NOTE: *Type of RT is at discretion of treating physician and may include either 3D-conformal RT or intensity-modulated RT. - Arm II: Patients receive androgen-deprivation therapy comprising luteinizing-hormone releasing-hormone (LHRH) agonist (leuprolide, goserelin, buserelin, or triptorelin) subcutaneously or as an injection every 1 to 3 months AND an oral antiandrogen therapy (flutamide 3 times daily or bicalutamide once daily) for 6 months. Beginning 8 weeks after the first LHRH injection, patients undergo radiotherapy as in arm I. After completion of study therapy, patients are followed up periodically.

   NCT ID:

   NCT00936390

   IRB Number:

   11-000264

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   Who can I contact for additional information about this study?

   Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   Jacksonville: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   

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4. MR-Guided Cryoablation of Prostate Bed Recurrences Rochester, MN View Summary
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   MR-Guided Cryoablation of Prostate Bed Recurrences

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   The purpose of this research is to see if MR-guided cryoablation can effectively treat prostate tumor recurrences.

   NCT ID:

   NCT01727284

   IRB Number:

   12-002245

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   Who can I contact for additional information about this study?

   Rochester: Connie L. Sathre 507-538-0540
                       
   
   
   

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5. Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance Scottsdale and Phoenix, AZ Rochester, MN View Summary
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   Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance

   Location:

   Scottsdale and Phoenix, AZ Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES: Primary - To determine if a telephone-based dietary intervention compared to no intervention will decrease clinical progression in AS patients. Secondary - To compare the incidence of active treatment (surgery, irradiation, local ablation, or androgen deprivation) in AS patients receiving dietary intervention compared to no intervention. - To compare prostate cancer-related anxiety in AS patients receiving dietary intervention compared to no intervention. - To compare health-related quality of life in AS patients receiving dietary intervention compared to no intervention. OUTLINE: This is a multicenter study. Patients are stratified according to age (≤ 70 years vs > 70 years), race (African American vs other), and time of baseline prostate biopsy (0-12 months before registration vs > 12-24 months before registration). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive the MEAL program intervention with dietary education and telephone counseling sessions for 24 months. Patients receive the "Participant Notebook", which provides written material describing the counseling program. It also outlines the dietary targets, offers supporting information on strategies to achieve these targets, supplies referent tools to help patients accurately estimate servings of target foods, and offers recipes and articles about diet and prostate cancer. The counseling sessions are divided into 4 phases, with the first three phases completed in 7 months and the fourth phase continuing for 17 months. The first phase comprises 6 counseling calls focusing on education and the rapid development of self-efficacy, the second phase comprises 4 calls over a 2-month period focusing on practical and consistent implementation of the dietary pattern, the third phase comprises 4 calls over a 4-month period helping patients habituate to the dietary pattern by providing regular performance reviews, and the fourth phase comprises 8 calls over a 17-month period and is a maintenance phase. Patients are encouraged to achieve 7 servings per day of vegetables (2 cruciferous, 2 tomato products, 3 other vegetables), 2 servings per day of whole grains, 1 serving per day of beans or other legumes, and 2 servings per day of fruit. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters focus on study goals and progress and provide tips on achieving and maintaining diet change. They also include information on diet and cancer, the challenges of diet change, the advances in prostate cancer control, and new recipes. - Arm II: Patients receive standard United States Department of Agriculture dietary guidelines for Americans. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters contain general information about diet and healthy lifestyle. Blood (plasma and serum) and tissue samples are collected at baseline and at 12 and 24 months for biomarker and pharmacogenomic studies. Patients complete quality-of-life assessments (Personal Habits Questionnaire, Functional Assessment of Cancer Therapy Scale-Prostate (FACT-P), Memorial Anxiety Scare for Prostate Cancer (Max-PC), International Prostate Symptom Score (IPSS), Expanded Prostate Cancer Index Composite 26 (EPIC-26), and Nutrition Self-Efficacy and Satisfaction with the MEAL Program) at baseline and at 6, 12, 18, and 24 months. After study entry, patients are followed up every 3 months for 2 years.

   NCT ID:

   NCT01238172

   IRB Number:

   12-000517

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   Who can I contact for additional information about this study?

   Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   
   

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6. MR-Guided Laser Ablation of Prostate Bed Recurrences Rochester, MN View Summary
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   MR-Guided Laser Ablation of Prostate Bed Recurrences

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   The purpose of this study is to see if MR-guided laser ablation can effectively treat prostate tumor recurrences.

   NCT ID:

   NCT01743638

   IRB Number:

   09-001584

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   Who can I contact for additional information about this study?

   Rochester: Connie L. Sathre 507-538-0540
                       
   
   
   

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7. A Phase 2 Diagnostic Imaging Study With 99mTc-MIP-1404 in Men With High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology Rochester, MN View Summary
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   A Phase 2 Diagnostic Imaging Study With 99mTc-MIP-1404 in Men With High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   This is a single arm, open label study of approximately 100 high-risk prostate cancer patients scheduled for prostatectomy and extended pelvic lymph node dissection. Patients receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard of care, patients will undergo prostatectomy and extended pelvic lymph node dissection (EPLND) within three weeks of study drug dosing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.

   NCT ID:

   NCT01667536

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   Who can I contact for additional information about this study?

   Rochester: Jane E Smith 507-266-8788
                       Nicole Allison 303-702-0564
   
   
   

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8. A Phase 3 Efficacy Study of a Recombinant Vaccinia Virus Vaccine to Treat Metastatic Prostate Cancer Rochester, MN View Summary
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   A Phase 3 Efficacy Study of a Recombinant Vaccinia Virus Vaccine to Treat Metastatic Prostate Cancer

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   BNIT-PRV-301 is a randomized, placebo-controlled, multi-center, global Phase 3 efficacy trial of PROSTVAC in men with asymptomatic or minimally symptomatic, metastatic, castrate-resistant prostate cancer. It is a 3-arm study and will evaluate overall survival in two separate comparisons, PROSTVAC plus adjuvant dose GM-CSF versus controls, and PROSTVAC without GM-CSF versus controls. Patients will be randomized with equal probability into one of three double-blind arms. The intended interventions for randomized patients are: 1. (Arm V+G) PROSTVAC-V/F plus adjuvant dose GM-CSF 2. (Arm V) PROSTVAC-V/F plus GM-CSF placebo 3. (Arm P) Double placebo

   NCT ID:

   NCT01322490

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   Who can I contact for additional information about this study?

   Rochester: 507-284-3369
                       
   
   
   

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