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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of combining surgery and radiation therapy in treating prostate cancer that has returned or spread. The study will assess whether these treatments can effectively eliminate cancer cells and improve patient outcomes. Participants will be divided into three groups: one receiving hypofractionated radiation therapy, another undergoing surgery, and a third receiving both treatments. This trial may suit individuals with recurrent prostate cancer and up to ten cancer spots in lymph nodes or bones. As a Phase 2 trial, it focuses on measuring the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that hypofractionated radiation therapy, which involves larger doses of radiation in fewer sessions, is generally safe for patients. Studies involving thousands of men have not identified any severe side effects, indicating it is well-tolerated.

For stereotactic body radiation therapy (SBRT), which precisely targets the tumor, the results are similar. Research indicates no significant long-term side effects compared to traditional radiation methods.

Oligometastasectomy, a surgery to remove cancer that has spread to a few small areas, has also been studied. In one study, most patients responded well without severe complications shortly after surgery.

Overall, these treatments have demonstrated promising safety in earlier studies, meaning they are generally well-tolerated and major side effects are rare. This is important information to consider when evaluating participation in a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for recurrent prostate cancer, which often rely on hormone therapy or conventional radiation over several weeks, the investigational treatments in this trial offer more targeted and potentially quicker interventions. Hypofractionated radiation therapy delivers higher doses of radiation in fewer sessions, which can shorten the treatment timeline and reduce the burden on patients. Salvage oligometastasectomy aims to surgically remove specific metastases, offering a more personalized approach by directly targeting cancerous nodes. Researchers are excited because these techniques could provide more effective, less invasive options with faster recovery times, ultimately improving quality of life for patients.

What evidence suggests that this trial's treatments could be effective for recurrent prostate cancer?

Research has shown that hypofractionated radiation therapy, one of the treatments in this trial, effectively treats prostate cancer, with 98% of patients surviving at least five years without cancer progression. In this trial, some participants will receive stereotactic body radiation therapy (SBRT), which effectively controls cancer that has spread to a few areas. Other participants will undergo salvage oligometastasectomy, a surgery to remove cancer that has spread, which studies indicate can lead to good results with few side effects for prostate cancer patients. These treatments, whether used alone or together in this trial, have shown promise in managing prostate cancer that has returned or spread. ^{2 3 6 7 8}

Who Is on the Research Team?

Alejandro Sanchez

Principal Investigator

Huntsman Cancer Institute/ University of Utah

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5002023/

Treatment outcomes with hypofractionated high-dose ... The prostate cancer-specific survival at 5 years was 98%, Fig. 1b. In general, the progression-free survival rate at 5 years was 86.6%, and 94%, 89% and 74% (p ...

2. uclahealth.org uclahealth.org/news/release/study-confirms-safety-and-efficacy-higher-dose-per-day

Study confirms safety and efficacy of higher-dose-per-day ... The analysis found patients who received isodose MHFRT (60 Gy in 20 fractions) had similar cancer control and side effects compared to those ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1879850023001753

Long-Term Outcomes of a Prospective Study on Highly ... In this study, the efficacy and safety of highly hypofractionated IMRT in 15 fractions were evaluated for low- to intermediate-risk prostate cancer. The 5- and ...

4. oncologynurseadvisor.com oncologynurseadvisor.com/features/moderately-hypofractionated-radiotherapy-in-prostate-cancer/

Hypofractionated Radiotherapy in Prostate Cancer Both isodose & dose-escalated MHFRT offer rates of progression-free & overall survival comparable to those seen with conventional ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT185918

Hypofractionated radiation therapy in low-risk prostate cancer Results: Median follow-up was 54 months (range 11-116 months). The actuarial 8-years Overall Survival was 97.1%. Eight-years Cancer Specific Survival was 100%, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12548115/

evidence from 9074 men in 13 randomized clinical trials There was no statistically significant difference in relapse-free survival after five years of treatment between the HFRT and CFRT groups. In ...

7. renalandurologynews.com renalandurologynews.com/news/hypofractionated-radiation-for-high-risk-prostate-cancer-offers-similar-survival/

Hypofractionated Radiation for High-Risk Prostate Cancer ... At 5 years, rates of overall survival (90.3% vs 89.7%), prostate cancer-specific survival (97.4% vs 97.5%), biochemical recurrence-free survival ...

8. dovepress.com dovepress.com/hypofractionated-radiotherapy-for-prostate-cancer-a-comparative-study--peer-reviewed-fulltext-article-CMAR

Hypofractionated Radiotherapy for Prostate Cancer Hypofractionated Radiotherapy for Prostate Cancer: A Comparative Study of Clinical Outcomes and Dosimetry Between Proton and Photon Therapy.