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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).

Must not have

Known brain or visceral metastases other than lymph nodes as defined by CT, MRI, or other molecular imaging (e.g., fluciclovine PET/CT or PSMA PET/CT scan or other per PI discretion).

Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My PSA levels have increased by 2ng/mL or more after treatment without surgery.

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My cancer spread is limited to pelvic or para-aortic lymph nodes, confirmed by a special scan.

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I am eligible for surgery if needed according to my treatment plan.

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If my biopsy is positive, I must have surgery or radiation on my prostate along with the study treatment.

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I can take care of myself but might not be able to do heavy physical work.

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My prostate cancer was confirmed through a tissue examination.

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My prostate cancer has come back after initial treatment.

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My prostate biopsy was negative, so I don't need extra prostate treatment.

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My cancer has spread to 10 or fewer places in my bones or lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cancer spread to my brain or organs, confirmed by scans.

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I am currently on IV antibiotics for a bacterial or fungal infection.

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I have liver problems causing jaundice or blood clotting issues.

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I haven't been hospitalized for COPD or other lung issues in the last 30 days.

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I haven't had a stroke, heart attack, or blood clot in the last 6 months.

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My high blood pressure is not controlled even with medication.

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I do not have severe heart failure or unstable heart conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Prostate-specific antigen (PSA) response rate

Secondary study objectives

Assess impact of study treatment on Change in quality of life over 3 years

Incidence of adverse events

PSA progression-free survival (PFS)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2140