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Standard Therapy + Surgery/Radiation for Prostate Cancer
Study Summary
This trial is testing whether adding surgery or radiation therapy to standard treatment for prostate cancer that has spread to other parts of the body lowers the chance of the cancer growing or spreading.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 87 Patients • NCT02066181Trial Design
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- My prostate is intact and I haven't had any treatment for prostate cancer.I have been on hormone therapy for prostate cancer for 22 to 28 weeks.I am not planning to receive docetaxel treatment after being assigned to a study group.I am fully active or restricted in physically strenuous activity but can do light work.I have prostate cancer with up to four metastases and may receive targeted therapy before being placed in a study group.I had a full physical exam and shared my medical history within the last 28 days.I have no cancer history, except for certain skin cancers, early-stage cancers in remission, or any cancer I've been free from for 3 years.I am not planning to receive docetaxel treatment after being assigned to a study group.I've had targeted therapy for up to 4 cancer spread sites, completed before joining.My cancer has not worsened in the last 28 weeks according to tests and I haven't felt worse.My scans show cancer has spread, and it's been confirmed with specific tests.I have been diagnosed with prostate adenocarcinoma, not small cell or squamous cell carcinoma.My prostate is intact and I haven't had treatments for prostate cancer, but treatments for benign conditions are okay.I have seen a urologist and my disease can be surgically removed.I have no cancer history except for certain treated cancers or any from which I've been disease-free for 3 years.My scans show cancer has spread and I've had these tests within the last 42 days.My prostate cancer is confirmed by lab tests but not small cell, sarcomatoid, or squamous type.I do not have brain metastases and show no signs of brain-related symptoms.I have had treatment for up to 4 cancer spread sites before joining this study.I have had less than 28 weeks of standard treatment for metastatic prostate cancer.My condition did not worsen while on hormone therapy.I have a PSA test result from before starting hormone therapy and within the last 28 days.I am willing to contribute samples for research.I can complete health surveys in English, Spanish, or French.I have been on hormone therapy for prostate cancer for 22 to 28 weeks.My testosterone level is below 50 ng/dL.I do not have brain metastases.I have had a testosterone test within the last 28 days.My cancer hasn't worsened in the last 28 weeks according to tests and doctor's observation.I have seen a urologist and my condition can be treated with surgery.Any side effects from my previous cancer treatment have mostly gone away.My condition did not worsen while on hormone therapy.I have had less than 28 weeks of standard treatment for metastatic prostate cancer.I am fully active or restricted in physically strenuous activity but can do light work.I have been diagnosed with prostate adenocarcinoma, not small cell or squamous cell carcinoma.My prostate is intact and I haven't had any treatment for prostate cancer.I do not have brain metastases.I have had less than 28 weeks of standard treatment for metastatic prostate cancer.I have prostate cancer with up to four treated metastases.I have not worsened while on hormone therapy for my cancer.My scans show cancer has spread and I've had these tests within the last 42 days.I can complete health surveys in English, Spanish, or French.Any side effects from my previous treatment have mostly gone away.
- Group 1: Arm I (SST)
- Group 2: Arm II (SST, prostatectomy or radiation therapy)
- Group 3: Step 1 (pre-randomization)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Can you please share prior research on Quality-of-Life Assessment?
"Quality-of-Life Assessment was first researched in 1995 at National Institutes of Health Clinical Center. In the years since, there have been nearly 3000 completed clinical trials on the topic. As of now, 1002 clinical trials are still active and recruiting patients. A high concentration of these active trials are based in Troy, Michigan."
Is Quality-of-Life Assessment a health risk for people?
"There is some data to support the efficacy of Quality-of-Life Assessment, and it has received multiple rounds of data supporting its safety, so it is estimated to be a 3 on a scale from 1 to 3."
Are people with the condition currently being accepted into the trial?
"That is correct. The clinical trial, which was first posted on 2018-09-17, is currently seeking patients. The most recent update was on 2021-11-08. They are hoping to enroll 1273 patients from 100 different sites."
What is the target number of participants for this clinical trial?
"To enroll the 1273 patients required for this study, we are looking for individuals that fit the specified inclusion criteria and are willing to travel to one of our 21st Century Oncology MHP - Troy in Troy, Michigan or University of Chicago Comprehensive Cancer Center in Chicago, Missouri."
What is the standard Quality-of-Life Assessment measuring?
"Quality-of-Life Assessment can be used to treat a diverse set of issues, such as scalp structure, kidney failure, acute burns, and other less severe burns."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Average response time
- < 1 Day
Most responsive sites:
- Radiation Oncology Centers of Nevada Central: < 24 hours
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