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This report outlines the objectives, methodologies, and preliminary results of a clinical trial investigating the safety and efficacy of an Adenovirus/PSA vaccine for treating hormone-refractory prostate
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How to fill out phase ii study of
How to fill out Phase II Study of Adenovirus/PSA Vaccine in Men with Recurrent Prostate Cancer after Local Therapy
01
Review the study protocol for the Phase II trial of the Adenovirus/PSA vaccine.
02
Ensure eligibility criteria for participants are clearly defined.
03
Obtain necessary ethical approvals and informed consent from participants.
04
Recruit a sufficient number of male participants with recurrent prostate cancer after local therapy.
05
Administer the Adenovirus/PSA vaccine according to the study schedule.
06
Monitor participants for adverse effects and efficacy of the vaccine.
07
Collect data on clinical outcomes and biomarkers at specified time points.
08
Analyze data using appropriate statistical methods.
09
Prepare reports and publications based on findings.
Who needs Phase II Study of Adenovirus/PSA Vaccine in Men with Recurrent Prostate Cancer after Local Therapy?
01
Men diagnosed with recurrent prostate cancer after local therapy.
02
Patients looking for novel therapeutic options.
03
Individuals who have not responded to standard treatment.
04
Researchers investigating the efficacy of vaccines for prostate cancer.
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People Also Ask about
What is the new wonder drug for prostate cancer?
This suggests that disrupting the heat shock response could help slow the growth of prostate cancer – and this is precisely what the team found. The drug (currently named NXP800) slowed the growth of prostate cancer cells, even those that were resistant to enzalutamide.
What is the best option for recurrent prostate cancer?
Salvage Prostatectomy This is a highly complex procedure with important considerations regarding quality-of-life but often is the only remaining curative option for men with recurrent prostate cancer.
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With the expanded approval of enzalutamide (Xtandi), oncologists have a new treatment option to offer some patients with prostate cancer who have had a biochemical recurrence. The number of treatment options for prostate cancer has exploded over the last decade.
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Still, 5 out of 6 people with recurrent prostate cancer go on to live for 5 years or more after treatment. Even after successful treatment of prostate cancer, it's possible for the cancer to return. Prostate cancer that returns after successful treatment is called “recurrent prostate cancer.”
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What is Phase II Study of Adenovirus/PSA Vaccine in Men with Recurrent Prostate Cancer after Local Therapy?
The Phase II Study of Adenovirus/PSA Vaccine is a clinical trial aimed at evaluating the safety and efficacy of a vaccine designed to stimulate the immune response against prostate-specific antigen (PSA) in men who have recurrent prostate cancer after undergoing local therapy.
Who is required to file Phase II Study of Adenovirus/PSA Vaccine in Men with Recurrent Prostate Cancer after Local Therapy?
The pharmaceutical company or research institution conducting the trial is required to file the Phase II Study of Adenovirus/PSA Vaccine, ensuring compliance with regulatory requirements and maintaining oversight by relevant health authorities.
How to fill out Phase II Study of Adenovirus/PSA Vaccine in Men with Recurrent Prostate Cancer after Local Therapy?
Filling out the study documentation involves providing detailed information regarding the study design, inclusion and exclusion criteria for participants, methods of data collection, statistical analysis plans, and informed consent procedures, among other requirements.
What is the purpose of Phase II Study of Adenovirus/PSA Vaccine in Men with Recurrent Prostate Cancer after Local Therapy?
The purpose of the study is to assess the vaccine's ability to elicit a targeted immune response against prostate cancer cells expressing PSA and to determine if it can prolong survival or improve quality of life for men with recurrent prostate cancer.
What information must be reported on Phase II Study of Adenovirus/PSA Vaccine in Men with Recurrent Prostate Cancer after Local Therapy?
Key information that must be reported includes participant demographics, safety data, adverse events, the efficacy of the vaccine based on measurable outcomes, protocol deviations, and overall survival rate, among other clinical outcomes.
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