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Hormone Therapy
Systemic + Tumor-Directed Therapy for Prostate Cancer
Phase 2
Waitlist Available
Led By Nicholas George Nickols, MD PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of 1-5 visible metastases (by NaF PET-CT or PSMA PET-CT including diagnostic CT of the chest, abdomen, and pelvis)
Metastases must be amenable to treatment with SBRT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is for patients with newly diagnosed metastatic prostate cancer with 5 or fewer metastases. The treatment involves surgery, hormone therapy, and radiotherapy.
Who is the study for?
This trial is for adults with newly diagnosed metastatic prostate cancer who have 5 or fewer metastases and are fit to undergo surgery, radiotherapy, and hormone therapy. They must not have a history of certain other cancers, severe liver impairment, or conditions that could lead to seizures.Check my eligibility
What is being tested?
The study tests the combination of surgery (prostate removal) or radiation to the prostate with six months of hormone therapy and targeted radiotherapy on metastasis sites. It aims to see how well these treatments work together in controlling cancer spread.See study design
What are the potential side effects?
Possible side effects include those from surgery like pain and infection risk; radiation may cause skin irritation and fatigue; hormone therapies can lead to hot flashes, decreased libido, osteoporosis; while targeted therapies might result in localized discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have 1 to 5 visible cancer spread sites on my scans.
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My cancer spread can be treated with targeted radiation.
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I am healthy enough for major prostate cancer surgery and targeted radiation.
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My kidney function, measured by GFR, is at least 45 mL/min.
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I am 18 years old or older.
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My cancer has spread to distant parts of my body.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer has not spread to my internal organs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PSA<0.05ng/mL (radical prostatectomy) or PSA <nadir+2ng/mL (prostate radiation)
Secondary outcome measures
Number of participants with treatment-related adverse events as assessed by physician using CTCAE v4.0 criteria
Patient reported outcomes as assedded by Functional Assessment of Cancer Therapy - Prostate (FACT-P) scale - patient questionnaire
Prostate cancer specific survival
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Experimental ArmExperimental Treatment5 Interventions
Radical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
stereotactic body radiotherapy
2016
Completed Phase 4
~140
Leuprolide
2008
Completed Phase 4
~18970
apalutamide
2023
Completed Phase 1
~10
abiraterone
2016
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,575 Total Patients Enrolled
15 Trials studying Prostate Cancer
8,785 Patients Enrolled for Prostate Cancer
Nicholas George Nickols, MD PhDPrincipal InvestigatorVA Greater Los Angeles Healthcare System, West Los Angeles, CA
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Prostate Cancer
60 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I'm sorry, but you haven't provided any specific criteria. Could you please provide the specific criteria you would like me to summarize?I have no other cancers except for minor skin or bladder cancers.I have a stomach or intestine condition that affects how my body absorbs food.I have 1 to 5 visible cancer spread sites on my scans.My largest pelvic node is smaller than 2 cm.I have attempted or considered a biopsy for my metastasis, or had an MRI if a biopsy was unsafe.I have signs of pressure on my spinal cord.I cannot have surgery, radiation, or hormone therapy for my prostate cancer.My prostate cancer is primarily small cell or has neuroendocrine features.My liver is not working well (severe issues).My cancer has spread to my internal organs.My cancer spread can be treated with targeted radiation.I am healthy enough for major prostate cancer surgery and targeted radiation.My testosterone level was above 200 ng/dL before starting hormone therapy.I stopped taking any seizure-risk increasing meds 4 weeks ago.I have a condition or history that might increase my risk of seizures.I haven't had serious heart issues or strokes in the last 6 months.I do not have an active infection like HIV or hepatitis.I am taking medication that is sensitive to changes in its breakdown by the body.I have been diagnosed with prostate adenocarcinoma, not primary small cell carcinoma.My kidney function, measured by GFR, is at least 45 mL/min.To provide a simplified summary, I would need more specific information about the history criteria you are referring to. Please provide additional details so I can assist you accurately.I am 18 years old or older.I have inflammatory bowel disease or an active connective tissue disorder.My cancer has spread to distant parts of my body.I am fully active or restricted in physically strenuous activity but can do light work.I have had radiation therapy to my pelvic area before.I have had cancer in my pelvic area before.I take more than 10 mg of prednisone or similar daily for a chronic condition.I am not taking strong CYP3A4 inducer medications, or I am willing to adjust my medication.My cancer has not spread to my internal organs.My high blood pressure is not under control.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What have been the observed risks of undergoing radical prostatectomy?
"The safety of radical prostatectomy is estimated to be a 2 on the scale due to its current status as a Phase 2 trial, which signifies that although there are indications for its security, no information exists regarding efficacy."
Answered by AI
Have researchers previously conducted research involving radical prostatectomy?
"Currently, there are 166 ongoing studies focused on radical prostatectomy treatment with 52 of these trials in their final stage. The majority of these clinical trials for this medical intervention take place in Duarte, California; however, 12018 other sites have also opened up research initiatives related to radical prostatectomy."
Answered by AI
What type of condition can typically be remedied by a radical prostatectomy?
"Radical prostatectomy is frequently utilized to treat advanced forms of prostatic cancer, but also can be employed in cases such as castration-resistance, hormone therapy resistance, and non-metastatic prostate cancers."
Answered by AI
What is the cap on participants for this clinical experiment?
"Sadly, this clinical trial has ceased accepting participants. It was initial posted on July 1st 2018 and last updated on March 16th 2022. However, there are still 1247 studies involving prostate cancer and 166 for radical prostatectomy that require volunteers."
Answered by AI
Are new participants being added to this research endeavor currently?
"It appears that, according to clinicaltrials.gov's records, this medical trial is not seeking participants at the moment. Initially posted on July 1st 2018 and last updated in March 16th 2022, there are currently 1413 other trials enrolling patients."
Answered by AI
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