Radiotherapy + Systemic Therapy for Oligometastatic Prostate Cancer

Recruiting at 8 trial locations

Overseen By Nicole Helie

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of Maryland, Baltimore

Disqualifiers: Castration-resistant prostate cancer, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

122 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of prostate radiation and systemic therapy to improve outcomes for men with prostate cancer that has spread to a few areas, such as bones or soft tissues. The trial compares two groups: one receiving the best systemic therapy and prostate radiation, and the other adding an additional focused radiation treatment to target metastases (areas where cancer has spread). Men with asymptomatic metastatic prostate cancer diagnosed within the last six months might be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you may have had prior systemic therapy, so it's possible you can continue some treatments. 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 shows that the treatment options under study, including prostate radiation, a precise form of radiation called SABR, and systemic therapy, have promising safety records for patients with prostate cancer.

In earlier studies, prostate radiation was well-tolerated, with few major side effects. SABR, which targets tumors precisely, was also safe and effective in controlling local tumors, and patients generally tolerated it well.

Systemic therapy, involving treatments that travel through the bloodstream, showed a low rate of side effects when combined with other treatments. It is considered a safe option for many prostate cancer patients.

Overall, various studies have tested these treatments and shown them to be safe for prostate cancer patients. Any side effects are usually mild and manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for oligometastatic prostate cancer because they combine different radiation therapies with systemic therapy to potentially enhance outcomes. Stereotactic ablative radiation therapy (SABR) targets metastatic sites with high precision and intensity, possibly leading to better control of cancer spread with fewer side effects compared to traditional therapies. Additionally, the combination of SABR with primary prostate radiation and best systemic therapy (BST) might address both the primary tumor and metastases more effectively than standard treatments alone, which typically focus on either local or systemic approaches but not both simultaneously. This integrated strategy could offer a more comprehensive way to manage the disease, potentially improving survival and quality of life for patients.

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

Research shows that radiation therapy for the prostate can effectively treat prostate cancer by targeting the main tumor. This method helps control cancer growth and reduces symptoms. In this trial, participants may receive primary prostate radiation (XRT) combined with the best systemic therapy (BST). Another group will receive BST along with XRT and stereotactic ablative radiation therapy (SABR) as metastasis-directed therapy (MDT). Studies have found that SABR, a precise, high-dose form of radiation, improves outcomes for men with a limited spread of prostate cancer. Specifically, about one-third of patients remain cancer-free for a year after SABR, and some can avoid additional hormone treatments for up to five years. These treatments, along with other therapies, aim to control cancer that has spread, potentially improving long-term results for patients. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for prostate cancer patients who've had surgery or local radiation but now have up to three new bone or soft tissue metastases, with at least one in the bone. They should understand and consent to the study, have a life expectancy of over a year, be able to lie flat for scans and treatment, not be on other investigational drugs, and not have castration-resistant cancer.

Inclusion Criteria

I have 1-3 new bone or soft tissue cancer spots, with at least one in the bone, found in the last 6 months.

I can understand and am willing to sign the consent form.

PSA > 0.5 but <100.

Exclusion Criteria

I've had radiation on the same spot where my cancer is now, preventing more radiation.

My prostate cancer is not responding to hormone therapy.

I have suspected lung or liver cancer spread larger than 10 mm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care treatment with systemic therapy and primary prostate radiation, with or without additional stereotactic ablative radiation therapy (SABR) to metastatic lesions

2 years

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

5 years

Follow-up visits include quality of life assessments and monitoring for adverse events

What Are the Treatments Tested in This Trial?

Interventions

• Prostate radiation (XRT)
• Stereotactic ablative radiation therapy (SABR)
• Systemic Therapy

Trial Overview

The TERPS Trial is testing if adding stereotactic ablative radiation therapy (SABR) to systemic therapy improves outcomes in prostate cancer patients with limited metastatic spread after primary treatment failure. It targets those with three or fewer recent metastases.

How Is the Trial Designed?

Group I: Best systemic therapy (BST) + primary prostate radiation (XRT) Active Control 2 Interventions

Group II: BST + XRT + SABR metastasis-directed therapy (MDT) Active Control 3 Interventions

Prostate radiation (XRT) is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as External Beam Radiation Therapy (EBRT) for:

• Prostate cancer
• Localized prostate cancer
• Metastatic prostate cancer

Approved in European Union as Intensity-Modulated Radiation Therapy (IMRT) for:

• Prostate cancer
• Localized prostate cancer

Approved in United States as Proton Beam Therapy for:

• Prostate cancer
• Localized prostate cancer

Approved in Canada as Stereotactic Body Radiation Therapy (SBRT) for:

• Localized prostate cancer
• Metastatic prostate cancer

Approved in Japan as Brachytherapy for:

• Prostate cancer
• Localized prostate cancer

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

In a study of 44 prostate cancer patients treated with a combination of conventional pelvic radiation and an extreme hypofractionation SBRT boost, the five-year progression-free survival rate was an impressive 88.2%, indicating effective long-term control of the disease.

The treatment was associated with low rates of severe toxicity, with only 2.3% experiencing grade III or greater acute genitourinary and gastrointestinal side effects, suggesting that this approach is both effective and safe for patients with advanced prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/II Study of Extreme Hypofractionated Stereotactic Body Radiation Therapy Boost to Prostate for Locally Advanced, Node-Positive and Oligometastatic Cancer. Narang, K., Kadian, M., Venkatesan, K., et al.[2021]

In a study of 43 patients with oligometastatic prostate cancer treated with stereotactic body radiation therapy (SBRT), 67.4% showed a positive prostate-specific antigen (PSA) response, leading to a median androgen deprivation therapy-free survival (ADT-FS) of 15.6 months.

Patients treated with SBRT had a significantly longer ADT-FS compared to a control group, with 17.3 months versus 4.19 months, and experienced no severe adverse events, highlighting SBRT's safety and efficacy in delaying the need for hormone therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of Using Stereotactic Body Radiotherapy in Patients With Metachronous Oligometastases of Hormone-Sensitive Prostate Cancer Detected by [18F]fluoromethylcholine PET/CT. Bouman-Wammes, EW., van Dodewaard-De Jong, JM., Dahele, M., et al.[2022]

Stereotactic body radiotherapy (SBRT) for oligometastatic prostate cancer has shown a progression-free survival benefit compared to observation in two randomized phase II trials, indicating its potential effectiveness.

Radiation therapy to the primary tumor is recommended for patients with low metastatic burden, as it has been associated with an overall survival benefit, particularly in cases with up to three bone metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of radiotherapy to the primary tumor and metastases in patients with oligometastatic prostate cancer]. Le Roy, T., Baron, D., Vandendorpe, B., et al.[2021]

Stereotactic body radiation therapy (SBRT) demonstrated high local control rates (96.0% at 2 years) and was well tolerated among 75 patients with oligometastases of prostate cancer, indicating its efficacy and safety as a treatment option.

The study found that SBRT could effectively manage both metastatic hormone-sensitive prostate cancer (mHSPC) and metastatic castration-resistant prostate cancer (mCRPC), providing a potential alternative to delay androgen deprivation therapy (ADT) for mHSPC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-Term Outcomes and Clinical Efficacy of Stereotactic Body Radiation Therapy (SBRT) for Oligometastases of Prostate Cancer in China. Xu, C., Zhao, X., Ju, X., et al.[2022]

In a study of 29 patients with oligometastatic hormone-sensitive prostate cancer treated with external beam radiation therapy (EBRT) and androgen deprivation therapy, the median overall survival was 9.7 years, indicating promising long-term outcomes for this treatment approach.

Patients with de novo metastases experienced significantly better progression-free survival (2.0 years) compared to those with oligorecurrent disease (1.8 years), suggesting that the timing and nature of metastases may influence treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Outcomes of Patients on a Phase II Prospective Trial of Oligometastatic Hormone-Sensitive Prostate Cancer Treated With Androgen Deprivation and External Beam Radiation. Hao, C., Ladbury, C., Lyou, Y., et al.[2022]

Recent studies show that adding radiotherapy to the treatment of hormone-sensitive oligometastatic prostate cancer can improve patient outcomes, despite systemic therapy being non-curative and associated with side effects.

Advancements in PET imaging have enhanced the ability to detect metastatic disease, allowing for better patient selection for local therapies, which may lead to changes in treatment guidelines for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in Management of Oligometastatic Hormone-Sensitive Prostate Cancer. Kothari, G., Ost, P., Cheung, P., et al.[2020]

In the treatment of oligometastatic prostate cancer, combining local treatments like prostate irradiation with systemic therapies has been shown to improve overall survival compared to systemic treatment alone, as supported by randomized studies.

Irradiation of the prostate is now recommended as a standard care approach for patients with low metastasis burden, while radical prostatectomy may also enhance oncological outcomes, although the effectiveness of local treatments for newly diagnosed metastatic disease remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of primary oligometastatic prostate cancer]. Scharl, S., Hadaschik, B., Wiegel, T., et al.[2022]

In a study of 17 men with oligometastatic prostate cancer treated with stereotactic body radiation therapy (SBRT), local control was achieved in 100% of cases, and over half of the patients (53%) had an undetectable prostate-specific antigen (PSA) after treatment.

The treatment was well-tolerated, with only mild toxicities reported and no severe side effects (grade ≥3), indicating that SBRT is a safe and effective option for managing oligometastatic prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy in the treatment of oligometastatic prostate cancer. Ahmed, KA., Barney, BM., Davis, BJ., et al.[2022]

In a study of 205 prostate cancer patients treated with stereotactic body radiation therapy (SBRT), 99% completed the treatment without severe acute side effects, indicating that this method is safe and well-tolerated.

The most common acute side effects were mild to moderate, with 50.7% experiencing grade II genitourinary issues and 31.7% experiencing grade I gastrointestinal issues, but no patients had severe (grade ≥ 4) toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute side effects after definitive stereotactic body radiation therapy (SBRT) for patients with clinically localized or locally advanced prostate cancer: a single institution prospective study. Jorgo, K., Polgar, C., Stelczer, G., et al.[2022]

In a study of 87 men with oligometastatic prostate cancer treated with stereotactic ablative radiotherapy (SABR), the median disease-free survival (DMFS) was 21.8 months for hormone-sensitive patients, indicating a significant benefit from this treatment.

Combining SABR with short-term androgen-deprivation therapy improved both biochemical progression-free survival (bPFS) and DMFS in patients with oligorecurrent hormone-sensitive prostate cancer, suggesting a potential strategy for enhancing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival Outcomes and Pattern of Relapse After SABR for Oligometastatic Prostate Cancer. Mercier, C., Claessens, M., De Troyer, B., et al.[2022]

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oncologynurseadvisor.com

oncologynurseadvisor.com/features/radiation-therapy-for-prostate-cancer/

Advances in Prostate Cancer Radiation Oncology

Recent studies have advanced diverse approaches to radiation therapy for prostate cancer, including metastasis-directed radiotherapy, hypofractionated SBRT.

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hopkinsmedicine.org

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Radiation Therapy for Prostate Cancer

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Radiation Therapy in Oligometastatic Prostate Cancer

The results from these studies demonstrate that SABR is a safe and feasible form of MDT with systemic therapeutic effects in addition to ...