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Radiation Therapy
Oligometastasectomy + Radiation for Recurrent Prostate Cancer (SOAR Trial)
Phase 2
Waitlist Available
Led By Alejandro Sanchez
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Post radiotherapy/ablation (without radical prostatectomy): PSA rise >= 2ng/mL over nadir.
For patients with oligometastatic disease involving lymph nodes, metastasis is confined to the pelvic or para-aortic (below IMA) regions on molecular imaging (e.g., fluciclovine PET/CT or PSMA PET/CT scan or other per PI discretion).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
SOAR Trial Summary
This trial is testing whether surgery and radiation therapy are more effective than just radiation therapy in treating patients with prostate cancer that has returned or spread.
Who is the study for?
Men with recurrent prostate cancer after initial treatment, showing a rise in PSA levels or positive imaging for intraprostatic disease. They must have 10 or fewer metastases confined to lymph nodes and/or bones, be fit enough for surgery if needed, agree to use condoms if they can father children, and have recovered from previous treatments' side effects.Check my eligibility
What is being tested?
The trial is testing the effectiveness of combining surgery (oligometastasectomy) with different forms of radiation therapy (like intensity-modulated or stereotactic body radiation) on patients whose prostate cancer has returned or spread but remains limited in number and location.See study design
What are the potential side effects?
Potential side effects include typical reactions to radiation such as skin irritation at the treatment site, fatigue, nausea, urinary issues like increased frequency or discomfort; surgical risks involve bleeding, infection and impacts on sexual function.
SOAR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My PSA levels have increased by 2ng/mL or more after treatment without surgery.
Select...
My cancer spread is limited to pelvic or para-aortic lymph nodes, confirmed by a special scan.
Select...
I am eligible for surgery if needed according to my treatment plan.
Select...
If my biopsy is positive, I must have surgery or radiation on my prostate along with the study treatment.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My prostate cancer was confirmed through a tissue examination.
Select...
My prostate cancer has come back after initial treatment.
Select...
My prostate biopsy was negative, so I don't need extra prostate treatment.
Select...
My cancer has spread to 10 or fewer places in my bones or lymph nodes.
SOAR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prostate-specific antigen (PSA) response rate
Secondary outcome measures
Assess impact of study treatment on Change in quality of life over 3 years
Incidence of adverse events
PSA progression-free survival (PFS)
+3 moreSOAR Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm C (salvage oligometastasectomy, radiation therapy)Experimental Treatment6 Interventions
Patients with nodal metastases undergo salvage oligometastasectomy. Following recovery, patients undergo SBRT or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion. Within 4 months following completion of salvage therapy (defined as the combination of oligometastasectomy and/or bone radiation) and depending on PSA response as well as previous treatment, patients may receive adjuvant nodal IMRT.
Group II: Arm B (salvage oligometastasectomy)Experimental Treatment3 Interventions
Patients with nodal metastases undergo salvage oligometastasectomy.
Group III: Arm A (radiation therapy)Experimental Treatment4 Interventions
Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~130
Metastasectomy
2010
N/A
~100
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,095 Previous Clinical Trials
1,775,565 Total Patients Enrolled
8 Trials studying Prostate Cancer
5,349 Patients Enrolled for Prostate Cancer
Alejandro SanchezPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah
1 Previous Clinical Trials
153 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My PSA levels have increased by 2ng/mL or more after treatment without surgery.I have cancer spread to my brain or organs, confirmed by scans.I am eligible for surgery if needed according to my treatment plan.I do not have any severe, uncontrolled illnesses.I am willing and able to sign the consent form for the trial.I have liver problems causing jaundice or blood clotting issues.I haven't been hospitalized for COPD or other lung issues in the last 30 days.I haven't had a stroke, heart attack, or blood clot in the last 6 months.I don't need a biopsy for my prostate cancer recurrence after surgery.If my biopsy is positive, I must have surgery or radiation on my prostate along with the study treatment.I can take care of myself but might not be able to do heavy physical work.I will use condoms during and for 6 months after treatment, and my partner will use birth control.I had radiotherapy for prostate cancer and a scan showing recurrence, confirmed by a biopsy within the last year.I am currently on IV antibiotics for a bacterial or fungal infection.My cancer spread is limited to pelvic or para-aortic lymph nodes, confirmed by a special scan.My high blood pressure is not controlled even with medication.I haven't taken dutasteride in the last 90 days.My prostate cancer was confirmed through a tissue examination.I don't have any other cancers that could affect this treatment's safety or results.You are not using any treatments that are not allowed in this study.I am on hormone therapy for prostate cancer with testosterone levels above 50 ng/dL.I have not used finasteride in the last 30 days.My PSA levels are rising after prostate surgery.My prostate cancer has come back after initial treatment.I do not have severe heart failure or unstable heart conditions.I do not have any heart conditions.My prostate biopsy was negative, so I don't need extra prostate treatment.I have recovered from previous treatment side effects, or they are minor and stable.My cancer has spread to 10 or fewer places in my bones or lymph nodes.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (radiation therapy)
- Group 2: Arm B (salvage oligometastasectomy)
- Group 3: Arm C (salvage oligometastasectomy, radiation therapy)
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.
To what degree is Metastasectomy a risk-free procedure?
"Our team at Power has assigned Metastasectomy a safety score of 2 because Phase 2 trials have only provided evidence confirming its security, not necessarily its efficacy."
Answered by AI
How many volunteers are engaged in the experiment?
"Indeed, the information available on clinicaltrials.gov attests to this trial's ongoing recruitment efforts. It was first posted in September 2019 and last updated in January 2022; currently searching for 40 participants at a single site."
Answered by AI
Are there still available spots in this trial for participants?
"As per information available on clinicaltrials.gov, this medical trial is currently accepting participants. It was initially posted in September 2019 and the latest update was made in April 2022."
Answered by AI
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