Oligometastasectomy + Radiation for Recurrent Prostate Cancer

(SOAR Trial)

Overseen By Kristen Jewkes

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of Utah

Must not be taking: Hormone therapy, Finasteride, Dutasteride

Disqualifiers: Brain metastases, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 months

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well surgery and radiation therapy work in treating patients with prostate cancer that has come back or spread to other parts of the body. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Surgical procedures, such as oligometastasectomy, may remove tumor cells that have spread to other parts of the body. Surgery and radiation therapy may work better in treating patients with prostate cancer that has come back or spread to other parts of the body.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use finasteride or dutasteride close to the start of the trial. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Oligometastasectomy + Radiation for Recurrent Prostate Cancer?

Research shows that hypofractionated radiation therapy (HFRT) is safe and effective for localized prostate cancer, and stereotactic radiotherapy can be beneficial for patients with oligometastatic conditions. These findings suggest that similar approaches may be effective for recurrent prostate cancer. ^{1 2 3 4 5}

Is hypofractionated radiation therapy safe for prostate cancer patients?

Hypofractionated radiation therapy (HFRT) for prostate cancer is generally considered safe, with studies showing it is well tolerated and has comparable side effects to traditional radiation therapy. Some studies report greater short-term gastrointestinal side effects, but overall, it is a safe treatment option for prostate cancer. ^{1 4 6 7 8}

How is hypofractionated radiation therapy different from other treatments for recurrent prostate cancer?

Hypofractionated radiation therapy (HFRT) is unique because it delivers higher doses of radiation over fewer sessions compared to traditional radiation therapy, which can make treatment more convenient and potentially more effective for certain patients. This approach is being explored for its ability to improve outcomes in patients with oligometastatic prostate cancer, where cancer has spread to a limited number of sites. ^{1 2 3 4 5}

Research Team

Alejandro Sanchez

Principal Investigator

Huntsman Cancer Institute/ University of Utah

Eligibility Criteria

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.

Inclusion Criteria

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

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

I am willing and able to sign the consent form for the trial.

Exclusion Criteria

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

I do not have any severe, uncontrolled illnesses.

I have liver problems causing jaundice or blood clotting issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo salvage oligometastasectomy and/or radiation therapy as per institutional standard of care guidelines

6 months

Multiple visits (in-person) as per treatment schedule

Follow-up

Participants are monitored for safety, PSA progression-free survival, and quality of life changes

Up to 3 years

Regular follow-up visits (in-person and virtual)

Open-label extension (optional)

Participants may continue to be monitored for long-term outcomes and quality of life

Long-term

Treatment Details

Interventions

• Hypofractionated Radiation Therapy
• Intensity-Modulated Radiation Therapy
• Metastasectomy
• Stereotactic Body Radiation Therapy

Trial Overview 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.

Participant Groups

Group I: Arm C (salvage oligometastasectomy, radiation therapy) Experimental Treatment 6 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 Treatment 3 Interventions

Patients with nodal metastases undergo salvage oligometastasectomy.

Group III: Arm A (radiation therapy) Experimental Treatment 4 Interventions

Patients with bone metastases undergo SBR) or hypofractionated radiation per institutional standard of care guidelines at investigator's discretion.

Hypofractionated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Approved in European Union as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Approved in Canada as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Findings from Research

In a study involving 160 prostate cancer patients, both hypofractionated radiation therapy regimens (56 Gy in 16 fractions and 67 Gy in 25 fractions) were found to be safe, with manageable levels of acute gastrointestinal and urinary toxicity.

Acute grade ≥2 gastrointestinal toxicity occurred in 26% of patients in the 56 Gy group and 20% in the 67 Gy group, indicating that both treatment schedules are effective options with acceptable safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

4 Weeks Versus 5 Weeks of Hypofractionated High-dose Radiation Therapy as Primary Therapy for Prostate Cancer: Interim Safety Analysis of a Randomized Phase 3 Trial. Fonteyne, V., Sarrazyn, C., Swimberghe, M., et al.[2022]

In a phase II study involving 40 high-risk prostate cancer patients, dose-escalated hypofractionated radiotherapy (hfrt) combined with androgen suppression therapy was found to be feasible, delivering 75 Gy in 25 fractions with minimal acute gastrointestinal and genitourinary toxicities.

Only 16.6% of patients experienced grade 2 genitourinary toxicity and 12.9% experienced gastrointestinal toxicity, indicating that the treatment can be administered safely while still targeting the pelvic lymph nodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute toxicity of hypofractionated intensity-modulated radiotherapy for prostate cancer. Drodge, CS., Boychak, O., Patel, S., et al.[2018]

In a study of 132 prostate cancer patients receiving hypofractionated radiation therapy (HFRT), the treatment was found to be feasible with low acute gastrointestinal and genitourinary toxicities, with only 4% experiencing grade 3 toxicity.

The average prostate symptom score increased during treatment but returned to near baseline levels three months after completion, indicating manageable side effects and a positive impact on quality of life post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation Therapy for Prostate Cancer Using HYpofractionation Directed by UltraSound (RAPHYDUS): A Brazilian Public Health Care System Study. Faustino, FLC., Altei, WF., Canton, HP., et al.[2022]

In a clinical trial involving 201 patients with prostate cancer, the use of a hyaluronic acid rectal spacer significantly improved rectal dosimetry, with 98.5% of patients achieving a 25% or greater reduction in rectal volume receiving radiation, far exceeding the 70% target.

The spacer also reduced the incidence of acute grade 2 or higher gastrointestinal toxic effects, with only 2.9% of patients in the spacer group experiencing these effects compared to 13.8% in the control group, indicating a safer treatment option for hypofractionated radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyaluronic Acid Spacer for Hypofractionated Prostate Radiation Therapy: A Randomized Clinical Trial. Mariados, NF., Orio, PF., Schiffman, Z., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

4 Weeks Versus 5 Weeks of Hypofractionated High-dose Radiation Therapy as Primary Therapy for Prostate Cancer: Interim Safety Analysis of a Randomized Phase 3 Trial. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Acute toxicity of hypofractionated intensity-modulated radiotherapy for prostate cancer. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic radiotherapy for oligometastatic patients: developing of a response predictive model. [2019]

4. Poland pubmed.ncbi.nlm.nih.gov

Moderate hypofractionated helical tomotherapy for older patients with localized prostate cancer: long-term outcomes of a phase I-II trial. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Nodal and osseous oligometastatic prostate cancer: a cohort including the introduction of PSMA-PET/CT-guided stereotactic and hypofractionated radiotherapy with elective nodal therapy. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Radiation Therapy for Prostate Cancer Using HYpofractionation Directed by UltraSound (RAPHYDUS): A Brazilian Public Health Care System Study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Image Guided Hypofractionated Postprostatectomy Intensity Modulated Radiation Therapy for Prostate Cancer. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Hyaluronic Acid Spacer for Hypofractionated Prostate Radiation Therapy: A Randomized Clinical Trial. [2023]