Radiotherapy + Systemic Therapy for Oligometastatic Prostate Cancer

Recruiting at 8 trial locations

Overseen By Nicole Helie

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Maryland, Baltimore

Disqualifiers: Castration-resistant prostate cancer, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This research is being done to see if we can improve the outcome of prostate cancer patients who present with metastatic lesions at initial diagnosis.

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.

What data supports the effectiveness of this treatment for oligometastatic prostate cancer?

Research shows that adding stereotactic body radiation therapy (SBRT) to standard care for oligometastatic prostate cancer can improve survival and delay further metastases. Randomized studies also indicate that combining local and systemic treatments offers survival benefits compared to systemic treatment alone. ^{1 2 3 4 5}

Is the combination of radiotherapy and systemic therapy safe for treating oligometastatic prostate cancer?

Research shows that stereotactic body radiation therapy (SBRT) is generally safe for treating oligometastatic prostate cancer, with studies reporting no major side effects. ^{3 6 7 8 9}

How is the treatment of radiotherapy combined with systemic therapy unique for oligometastatic prostate cancer?

This treatment is unique because it combines targeted radiation techniques like stereotactic body radiation therapy (SBRT) and stereotactic ablative radiotherapy (SABR) with systemic therapies such as hormone therapy, aiming to improve survival and delay further metastases in patients with oligometastatic prostate cancer. ^{1 3 5 6 10}

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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 Canada, Japan for the following indications:

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+

Findings from Research

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]

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]

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 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 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]

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]

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 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 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]

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]

References

1. United States 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. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[The role of radiotherapy to the primary tumor and metastases in patients with oligometastatic prostate cancer]. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy in the treatment of oligometastatic prostate cancer. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Treatment of primary oligometastatic prostate cancer]. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Survival Outcomes and Pattern of Relapse After SABR for Oligometastatic Prostate Cancer. [2022]

6. United States 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. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Short-Term Outcomes and Clinical Efficacy of Stereotactic Body Radiation Therapy (SBRT) for Oligometastases of Prostate Cancer in China. [2022]

8. Poland 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. [2022]

9. United States 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. [2022]

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

Trends in Management of Oligometastatic Hormone-Sensitive Prostate Cancer. [2020]