As part of Us TOO’s continued commitment to bring news of new interventions and treatments for the benefit of prostate cancer patients, we are pleased to share this news with you about the following opportunities to participate in clinical trials.
Ablatherm® High Intensity Focused Ultrasound (HIFU) Clinical Trial For Localized Prostate Cancer [072806]
A phase III randomized, prospective, multi-center clinical study of High Intensity Focused Ultrasound (HIFU) for the treatment of low risk localized prostate cancer has been initiated in the United States. The objective of the study is to assess the safety and effectiveness of HIFU as compared to cryotherapy.
Click Here for clinical trials.gov listing with more information about this study
A Trial of Combined Cryotherapy and Intra-tumoral Immunotherapy with Autologous Immature Dendritic Cells (VDC2008) in Chemo-naïve Men with Prostatic Adenocarcinoma and Limited Metastases to Lymph Nodes and/or Bone (The “CRITICAL” Trial)
The purpose of this study is to determine whether intra-tumoral injection of subject’s own dendritic cells after cryotherapy of the prostate is safe and effective in the treatment of advanced prostate cancer. In theory, injected dendritic cells will internalize antigens from tumor cells damaged by cryotherapy and facilitate the initiation of a tumor-specific immune response. Subjects will also receive a low dose regimen of cyclophophamide pre- and post- cryotherapy to selectively reduce number of regulatory T cells (Treg), which have been implicated in dampening or halting immune responses. Using this combination of therapies, it is thought that a clinically significant anti-cancer immune response might be elicited.
Click Here for clinical trials.gov listing with more information about this study
Phase II Trial of an Adenovirus/PSA Vaccine for Recurrent Prostate Cancer [012010]
The University of Iowa and the Iowa City VA Medical Center are conducting a Phase II trial of a vaccine for the treatment of recurrent prostate cancer. Two protocols are active; one protocol treats hormone naïve patients who have experienced a recent, but continued rise in their serum PSA following initial treatment for their prostate cancer, and a second protocol treats men with hormone refractory prostate cancer. The hypothesis is that the vaccine will induce the production of anti-PSA and, therefore, anti-prostate cancer, immune responses that will cause the destruction of the cancer cells anywhere in the body.
Interested patients can contact the Clinical Trial Coordinator Ms. Pamela Zehr at 319-353-8914, pamela-zehr@uiowa.edu or Dr. David
Lubaroff at 319-335-8423, david-lubaroff@uowa.edu.
Click Here for clinicaltrials.gov
listing with more information about this study
AFFIRM (A Study Evaluating the EFFicacy and Safety of Investigational DRug MDV3100 in Men with Advanced Prostate Cancer) [012010]
Now enrolling patients, this trial will evaluate the efficacy and safety of the investigational drug MDV3100 as a treatment for advanced prostate cancer – specifically a type known as hormone-resistant prostate cancer. The study will evaluate the impact of MDV3100 on survival and other factors, including quality of life.
The first triple-acting, oral anti-androgen, MDV3100 has been shown in preclinical studies to provide more complete suppression of the androgen receptor pathway than the most commonly used anti-androgen, bicalutamide. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions – MDV3100 blocks testosterone from binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells and inhibits binding to DNA. Preclinical data published in Science demonstrated that MDV3100 is superior to bicalutamide in each of these three actions.
Patients who were previously treated with the chemotherapy drug docetaxel may be eligible for the study. Two-thirds of patients will randomly be assigned to receive MDV3100 while 1/3 will receive placebo (sugar pill), which does not contain active medicine.
For more information on eligibility and enrollment, patients can call the AFFIRM study hotline toll-free at 1-888-782-3256 or visit www.affirmtrial.com.
Click Here to read a flyer
Click Here for clinical trials.gov listing with more information about this study
Phase II Trial of an Adenovirus/PSA Vaccine for Recurrent Prostate Cancer [012010]
The University of Iowa and the Iowa City VA Medical Center are conducting a Phase II trial of a vaccine for the treatment of recurrent prostate cancer. Two protocols are active; one protocol treats hormone naïve patients who have experienced a recent, but continued rise in their serum PSA following initial treatment for their prostate cancer, and a second protocol treats men with hormone refractory prostate cancer. The hypothesis is that the vaccine will induce the production of anti-PSA and, therefore, anti-prostate cancer, immune responses that will cause the destruction of the cancer cells anywhere in the body.
Interested patients can contact the Clinical Trial Coordinator Ms. Pamela Zehr at 319-353-8914, pamela-zehr@uiowa.edu or Dr. David
Lubaroff at 319-335-8423, david-lubaroff@uowa.edu.
Click Here for clinicaltrials.gov
listing with more information about this study
Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC)
Subjects will receive the investigational product,
sipuleucel-T, at approximately 2-week intervals, for a total of 3 infusions. The study will evaluate the safety of and magnitude of the immune responses to treatment with
sipuleucel-T. All subjects will be followed for 30 days following the last infusion of
sipuleucel-T. The study is also available to placebo subjects who participated in the D9902B study.
Patients must fit criteria. This is a newer Provenge trial with no placebo.
Here are some basic criteria:
HRPC, testosterone < 50
metastatic
PSA at least 5.0
no lung, liver, or brain mets
might need to have address within driving distance of
trial site (ask about this)
At least 28 days since:
Chemotherapy,
Steroids,
External beam radiation therapy or surgery,
PC-SPES (or PC-SPEC) or Saw Palmetto,
Megestrol acetate (Megace(R)), diethylstilbesterol
(DES), or cyproterone acetate, ketoconazole,
5-alpha-reductase inhibitors (Proscar or Avodart),
antiandrogens (Casodex, flutamide, Nlandro),
High dose calcitriol (i.e., > 0.5 mg/day).
Click Here for clinical trials.gov listing with more information about this study and study sites
Click Here for further reading on Provenge before Taxotere
Click Here for further reading on immunotherapy & PCa
Strontium chloride treatment for hormone refractory prostate cancer that has spread to the bone [081708]
Clinical trial MDA-3410 is for men with Androgen Independent Prostate Cancer (AIPC)/Hormone Refractory Prostate Cancer (HRPC) that has spread to bone. The results of an earlier M.D. Anderson Cancer Center conducted clinical trial suggested that the addition of strontium chloride (Sr89) to a chemotherapeutic treatment regimen might improve outcomes for men with this stage of prostate cancer. This clinical trial will compare the effectiveness, in terms of overall survival, of therapy with or without strontium chloride (Sr89) after response to initial treatment with chemotherapy in men with AIPC/HRPC that has spread to bone.
This clinical trial is open for enrollment at study sites nationwide.
Click Here for a study summary that you can share with your healthcare team.
Click Here for a list of participating study sites. Click Here for clinical trials.gov listing with more information about this study
ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain [071108]
InSightec Ltd. is conducting an FDA approved phase III pivotal study (BM004) to evaluate the effectiveness and safety of ExAblate
(MR guided Focused Ultrasound, MRgFUS) for the palliation of pain from metastatic bone tumors in patients who are not suitable candidates to receive additional radiation therapy. ExAblate MRgFUS uses (focused) ultrasound to treat tissue without surgical cutting (i.e. non-invasive procedure). The ExAblate use for the palliation of pain from bone metastases is experimental. The study hypothesis is that ExAblate is safe and effective in the treatment of pain resulting from metastatic bone tumors in patients that did not respond to radiation treatment or who are otherwise unsuitable for radiation treatment, with a low incidence of co-morbidity.
This clinical trial is open for enrollment at study sites nationwide.
Click Here for a study summary and a list of participating sites. Click Here for more information about the studies and about bone metastases
Prostate Cancer Survivor & Partner Sexuality Research Survey
Seeking input on how prostate cancer treatments impinge on the sexuality of both partners. Participants will provide input via this anonymous, online survey. Separate survey forms for cancer survivors and partners.
Click Here for more information and links to surveys
NCI currently conducting trials for patients with prostate cancer -- The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), conducts more than 150 clinical trials at the NIH Clinical Center in Bethesda, MD. NCI is currently conducting clinical trials for patients with prostate cancer.
There is no charge for medical care received at the NIH Clinical Center. Study participants will be responsible for travel costs for their initial screening visits. Once participants are enrolled in a trial, NCI will pay for the transportation costs for all subsequent trial-related visits for participants who do not live in the local area. In addition, these participants will receive a small per diem for food and lodging expenses if they are being treated as outpatients.
For more information on clinical trials conducted at NCI, please visit
http://bethesdatrials.cancer.gov or call the Clinical Trials Referral Office (formerly Clinical Studies Support Center) at 1-888-NCI-1937 (1-888-624-1937).
The National Cancer Institute also sponsors clinical studies at cancer centers nationwide. To learn more about these studies, call 1-800-4-CANCER (1-800-422-6237).
