Prostatectomy for Prostate Cancer
Palo Alto (17 mi)Overseen byIsaac Kim
Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Rutgers, The State University of New Jersey
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This randomized phase II trial studies how well surgical removal of the prostate and antiandrogen therapy with or without docetaxel work in treating men with newly diagnosed prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Antiandrogen therapy may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Surgery, antiandrogen therapy and docetaxel may work better in treating participants with prostate cancer.
Is the treatment Antiandrogen Therapy, Docetaxel, and Radical Prostatectomy promising for prostate cancer?Yes, this treatment is promising for prostate cancer. Docetaxel, a drug used in this treatment, is a standard first-line therapy for advanced prostate cancer and has shown significant benefits in improving patient survival. It works by stopping cancer cells from growing and spreading. Combining it with other therapies like Antiandrogen Therapy and Radical Prostatectomy can enhance its effectiveness.156912
What safety data exists for prostate cancer treatments like prostatectomy and related therapies?Safety data for prostate cancer treatments, including prostatectomy and related therapies, indicate that docetaxel is a significant agent in treating hormone-refractory prostate cancer. It has been shown to be safe when used in combination with hormonal therapy and radiation therapy. Studies have demonstrated that docetaxel, when used as a single agent or in combination with other therapies, does not increase surgical morbidity and is safe at certain doses with modern radiation therapy. The FDA has approved docetaxel for advanced metastatic prostate cancer, and ongoing trials continue to evaluate its safety and efficacy in various treatment combinations.12378
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chemotherapy or radiotherapy for non-prostate cancer, you must not have received it within 3 weeks prior to consent.
What data supports the idea that Prostatectomy for Prostate Cancer is an effective treatment?The available research shows that combining docetaxel, a chemotherapy drug, with androgen deprivation therapy (ADT) improves survival in men with advanced prostate cancer. This combination is effective for both metastatic hormone-sensitive and castration-resistant prostate cancer. Additionally, docetaxel is the first drug to significantly extend survival in hormone-refractory prostate cancer, suggesting its potential benefit when used alongside other treatments like prostatectomy. While the research focuses on docetaxel and ADT, it implies that integrating these therapies with prostatectomy could enhance treatment outcomes for high-risk patients.2481011
Eligibility Criteria
Men with newly diagnosed metastatic prostate cancer who have started or plan to start antiandrogen therapy within the last 6 months. They must not have had previous local treatments for prostate cancer, should be able to undergo surgery, and have a life expectancy of more than 6 months. Their blood counts and liver enzymes need to be at certain levels, and they must be physically well enough (ECOG status of 0 or 1).Inclusion Criteria
My surgeon has determined my prostate can be surgically removed.
My hemoglobin level is at least 9 g/dL, making me fit for surgery.
My cancer has spread, confirmed by scans or tests.
My cancer has spread to distant lymph nodes, bones, or other organs.
My platelet count is above 80,000, suitable for surgery.
My liver enzyme ALT levels are within twice the normal limit.
My prostate cancer was confirmed through a tissue examination.
I have not had any local treatments for prostate cancer.
I am fully active or restricted in physically strenuous activity but can do light work.
My liver enzyme AST levels are within twice the normal limit.
Exclusion Criteria
I have had a blood clot in my leg or lung in the last 6 months.
I have pressure on my spinal cord.
I have been on hormone therapy for prostate cancer for over 6 months.
I haven't had chemotherapy or radiotherapy for conditions other than prostate cancer in the last 3 weeks.
I have had treatment directly on my prostate before.
Treatment Details
The trial is testing if removing the prostate gland surgically combined with hormone-blocking therapy works better with or without docetaxel chemotherapy in men whose prostate cancer has spread. The study will compare how these different treatments affect tumor growth by killing cells, stopping cell division, or preventing spread.
2Treatment groups
Experimental Treatment
Group I: Arm II (ADT, radical prostatectomy, docetaxel)Experimental Treatment6 Interventions
Participants receive antiandrogen therapy for at least 1 month, then undergo cytoreductive radical prostatectomy. Participants continue antiandrogen therapy and may receive docetaxel prior to surgery at the discretion of the treating physician.
Group II: Arm I (ADT, docetaxel)Experimental Treatment5 Interventions
Participants receive antiandrogen therapy with or without docetaxel at the discretion of the treating physician.
Antiandrogen Therapy is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Antiandrogen Therapy for:
- Prostate cancer
🇪🇺 Approved in European Union as Antiandrogen Therapy for:
- Prostate cancer
Find a clinic near you
Research locations nearbySelect from list below to view details:
Rutgers Cancer Institute of New JerseyNew Brunswick, NJ
City of HopeDuarte, CA
University of Southern CaliforniaLos Angeles, CA
Yale UniversityNew Haven, CT
More Trial Locations
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Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
Yale UniversityLead Sponsor
National Cancer Institute (NCI)Collaborator
References
[Treatment of androgen-independent hormone refractory prostate cancer using docetaxel]. [2018]Although prostate cancer patients with metastatic lesion initially respond to androgen ablation therapy, almost patients develop to hormone-refractory states. The optimal treatment for men with hormone refractory prostate cancer (HRPC) has not been established. Docetaxel is a semisynthetic taxane that inhibit tumor growth by induction of microtubule stabilization and promotion of bcl-2 inactivation, which induce apoptosis. Docetaxel as single agent has significant anti-tumor effect in HRPC patients. Docetaxel combined with estramustine or other antimicrotubular agents have shown further significant cytotoxicity in HRPC patients. In the United States, Food and Drug Administration (FDA) approved docetaxel, injection in combination with prednisone for the treatment of patients with advanced metastatic prostate cancer in 2004.
High-risk localized prostate cancer: integrating chemotherapy. [2018]Docetaxel (Taxotere); Aventis Pharmaceuticals Inc., Bridgewater, NJ, http://www.aventispharma-us.com) is the first agent to significantly extend survival in hormone-refractory prostate cancer. Because agents active in advanced cancers tend to be beneficial in earlier stage disease, docetaxel is now to be assessed, along with hormonal therapy, in the adjuvant setting among patients whose localized prostate cancer has features that put them at particular risk for recurrence and cancer-specific mortality. Data from a pilot study suggest that neo-adjuvant treatment with docetaxel may be appropriate for selected high-risk patients and that such treatment can be undertaken without increasing surgical morbidity. Gene-expression profiling of tissue before and after docetaxel treatment is providing further insight into its effects. A randomized trial, conducted by the Cancer and Leukemia Group B, will evaluate neoadjuvant docetaxel in high-risk patients, whereby patients will be randomized to either immediate radical prostatectomy or surgery preceded by hormonal therapy plus docetaxel. Another large randomized trial will be evaluating the effect of adjuvant hormonal therapy with or without docetaxel in high-risk men after radical prostatectomy.
[Toxicity and efficacy of intermittent docetaxel chemotherapy for hormone refractory prostate cancer]. [2018]Until today, docetaxel is the only EMEA and FDA approved active agent in hormone refractory prostate cancer (HRPC). In the absence of other effective and approved drugs we evaluated the toxicity and efficacy of intermittent-docetaxel-chemotherapy in patients whose cancers progressed after successful first-line docetaxel therapy.
Zibotentan for the treatment of castrate-resistant prostate cancer. [2014]Patients with prostate cancer who have progression of their disease while on androgen deprivation therapy have limited therapeutic options. Docetaxel is currently the only agent that increases overall survival in patients with metastatic, castration-resistant prostate cancer; additional agents are needed.
[Targeted therapies for hormone-refractory prostate cancer]. [2011]Prostate cancer is one of the most common type of cancer among men after middle age. Androgen withdrawal can delay its progression in the initial stage, but it finally becomes independent of androgens in almost all the cases. The combination of docetaxel with prednisone is currently a standard first-line treatment for patients with hormone-refractory prostate cancer (HRPC), but hitherto there is no established second-line therapy. In view of the molecular pathogenesis of HRPC, this article presents an overview on several promising drugs that target specific pathways, involving angiogenesis, cell signaling, apoptosis and proliferation, and immune modulation, either as single agents or in combination with cytotoxic chemotherapy.
Cabazitaxel for the treatment of prostate cancer. [2014]Prostate cancer is a frequently diagnosed male cancer. In men presenting locally advanced or metastatic disease, the mainstay of treatment is hormonal suppression. Despite the castrate levels of testosterone, with time, prostate cancer gradually evolves into a castration-refractory state. Chemotherapeutic agents are able to influence the natural history of metastatic castration-resistant prostate cancer. Docetaxel is a clinically relevant, FDA-approved taxane. Today, it is the first-line chemotherapeutic agent in castration-refractory prostate cancer (CRPC). There is no standard second-line chemotherapeutic regimen.
Phase I study of concurrent weekly docetaxel, high-dose intensity-modulated radiation therapy (IMRT) and androgen-deprivation therapy (ADT) for high-risk prostate cancer. [2019]Study Type - Therapy (phase 1) Level of Evidence 2a What's known on the subject? and What does the study add? High-risk and locally advanced prostate cancers are difficult to cure with the standard regimen of radiation therapy (RT) with concurrent androgen-deprivation therapy (ADT). Multiple studies have explored the addition of docetaxel chemotherapy in attempt to improve patient outcomes. Prior Phase I studies have shown that docetaxel 20 mg/m(2) is a safe dose, when given concurrently with 70 Gy of radiation. But current standard RT for prostate cancer uses higher doses, and it is unclear if concurrent chemotherapy is safe with modern RT. This is a Phase I study that explored the addition of concurrent docetaxel chemotherapy to modern RT (intensity-modulated RT to 78 Gy) plus ADT. The study showed that weekly docetaxel at 20 mg/m(2) is safe with modern RT. At a median follow-up of 2.2 years, biochemical progression-free survival was 94%. This triple-therapy regimen is safe and promising for further evaluation in prospective trials.
Survival Outcomes of Concurrent Treatment with Docetaxel and Androgen Deprivation Therapy in Metastatic Castration-Resistant Prostate Cancer. [2018]Docetaxel-based chemotherapy (DTX) improves overall survival (OS) of men with metastatic castration-resistant prostate cancer (mCRPC). Considering the potential existence of androgen receptors that remain active at this stage, we aimed to assess the impact of the combined use of androgen deprivation therapy (ADT) with DTX for mCRPC.
SEOM clinical guidelines for the treatment of metastatic prostate cancer (2017). [2018]Androgen deprivation treatment was the only treatment available for metastatic prostate cancer until recently, with docetaxel as the only treatment with a proven survival benefit in castration-resistant prostate cancer (CRPC). Several drugs have been approved in the castration-resistant disease (sipuleucel-T, cabazitaxel, abiraterone, enzalutamide, radium-223). More recently, docetaxel and abiraterone have been moved to the hormone-sensitive disease setting, achieving better patient survival. The purpose of this article is to define the state of the art in the treatment of prostate carcinoma.
Phase 2 Randomized Study of Radiation Therapy and 3-Year Androgen Deprivation With or Without Concurrent Weekly Docetaxel in High-Risk Localized Prostate Cancer Patients. [2019]Docetaxel improves survival in patients with metastatic prostate cancer. This randomized phase 2 trial aimed to assess the activity of weekly docetaxel with radiation therapy (RT) plus androgen deprivation in patients with high-risk localized prostate cancer. The study examined the benefit of 9 weekly docetaxel administrations to RT plus 3 years of luteinizing hormone-releasing hormone analogues.
Efficacy and Adverse Events of Docetaxel for Metastatic, Hormone-sensitive Prostate Cancer Among Elderly Men: A Post Hoc Analysis of the CHAARTED Trial. [2022]Combination therapy with docetaxel and androgen deprivation therapy (ADT) prolongs overall survival (OS) in men with metastatic hormone-sensitive prostate cancer. We assessed the benefits and adverse effects of docetaxel and ADT in relation to advancing age.
Prostate cancer and novel pharmacological treatment options-what's new for 2022? [2023]Androgen deprivation therapy (ADT) plus Androgen Receptor Target Agents (ARTAs) or docetaxel are the actual standard of care in prostate cancer (PC). Several therapeutic options are available for pretreated patients: cabazitaxel, olaparib, and rucaparib for BRCA mutations, Radium-223 for selected patients with symptomatic bone metastasis, sipuleucel T, and 177 LuPSMA-617.