Shorter vs Usual Radiation Therapy for Prostate Cancer

Recruiting at 376 trial locations

Overseen By Lara Hathout

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: NRG Oncology

Must be taking: Androgen deprivation therapy

Disqualifiers: Metastatic disease, Prior prostatectomy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 31

1209 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different radiation therapies to determine which better prevents high-risk prostate cancer from returning. Stereotactic Body Radiation Therapy (SBRT) delivers higher doses over two weeks, while External Beam Radiation Therapy (EBRT) spreads treatments over several weeks. The trial seeks to determine if the shorter treatment is as effective as the longer one. Men with high-risk prostate cancer, such as those with a high PSA level or a Gleason Score of 8–10, might be suitable candidates for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients taking 5-alpha reductase inhibitors like finasteride or dutasteride are eligible, so you may be able to continue those.

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

A previous study on stereotactic body radiation therapy (SBRT) for men with high-risk prostate cancer showed low levels of side effects. The study found the radiation to be safe and well-tolerated. Most patients received a radiation dose of 35–36.25 Gy over five sessions, similar to the current trial's plan. The research demonstrated that this treatment remained effective for many years with few negative reactions.

For external beam radiation therapy (EBRT), the usual method, safety data is also positive. It has been used for many years and is generally well-tolerated. Patients might need more sessions over a longer period, but this method is also considered safe.

Both SBRT and EBRT have shown safety in previous studies, though each has its own schedule and duration. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for prostate cancer because they explore different radiation therapy durations. Stereotactic Body Radiation Therapy (SBRT) is unique because it delivers high doses of radiation in just five treatments over two weeks, potentially offering a quicker and more convenient option compared to the standard External Beam Radiation Therapy (EBRT), which usually involves 20 to 45 sessions over 4 to 9 weeks. SBRT's precision may also reduce exposure to surrounding healthy tissues. This trial could reveal whether a shorter, more intense treatment is as effective and safe as the traditional, longer regimen.

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

This trial will compare Stereotactic Body Radiation Therapy (SBRT) with External Beam Radiation Therapy (EBRT) for prostate cancer. Research has shown that SBRT, which participants in this trial may receive, effectively controls prostate tumors with fewer side effects than traditional treatments. Studies have found that delivering a higher dose of radiation in fewer sessions can be just as effective for prostate cancer. Specifically, patients who received SBRT reported good tumor control and maintained their quality of life. Although some patients experienced urinary issues in the first two years, overall side effects remained low. This makes SBRT a promising option for treating high-risk prostate cancer in a shorter time. ^{6 7 8 9 10}

Who Is on the Research Team?

Karen E Hoffman

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

This trial is for men with high-risk prostate cancer confirmed by tests, a PSA level over 20 ng/mL, Gleason Score of 8-10, and certain conditions on imaging. Participants must have a prostate size under 100 cc without evidence of distant metastases. Men should be at least 18 years old with an ECOG Performance Status of 0-2 and no prior radiation in the same area.

Inclusion Criteria

My PSA level was over 20 ng/mL before starting hormone therapy.

My prostate gland is smaller than 100 cc before starting hormone therapy.

I can take care of myself and am up and about more than half of my waking hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment (SBRT)

Participants undergo stereotactic body radiation therapy (SBRT) for a total of 5 treatments over 2 weeks

2 weeks

5 visits (in-person)

Treatment (EBRT)

Participants undergo external beam radiation treatment (EBRT) for 20 to 45 treatments over 4 to 9 weeks

4-9 weeks

20-45 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• External Beam Radiation Therapy
• Stereotactic Body Radiation Therapy

Trial Overview The study compares two types of radiation therapy: SBRT (five treatments over two weeks) versus usual radiation (20 to 45 treatments over four to nine weeks). It aims to see if the shorter SBRT prevents cancer return as effectively as the longer usual treatment.

How Is the Trial Designed?

Group I: Arm I (SBRT) Experimental Treatment 8 Interventions

Patients undergo SBRT for a total of 5 treatments over 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan and/or CT, MRI, or PET/CT during screening and CT and/or MRI on study. Additionally, patients may optionally undergo blood and urine sample collection on study.

Group II: Arm II (EBRT) Active Control 7 Interventions

Patients undergo EBRT for 20 to 45 treatments over 4 to 9 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan and/or CT, MRI, or PET/CT during screening and CT and/or MRI on study. Additionally, patients may optionally undergo blood and urine sample collection on study.

External Beam Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in United States as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in Canada as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in Japan as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in China as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in Switzerland as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A review of 1241 patients treated with High Intensity Focused Ultrasound (Hifu) for radiorecurrent localized prostate cancer showed an overall survival rate of 85.2% at 5 years, indicating its effectiveness as a salvage treatment after External Beam Radiation Therapy (EBRT) failure.

The study analyzed patients with a mean age of 68.6 years and a PSA level of 5.87 ng/mL before treatment, with a follow-up period averaging 24.3 months, highlighting the potential of Hifu as a viable option for patients who do not respond to initial radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncologic outcome of salvage high-intensity focused ultrasound (HIFU) in radiorecurrent prostate cancer. A systematic review. Maestroni, U., Tafuri, A., Dinale, F., et al.[2021]

CyberKnife stereotactic ablative radiotherapy (SABR) for treating intermediate- to very-high-risk prostate cancer showed a high 3-year biochemical relapse-free survival rate of 90.2%, indicating its efficacy in managing this condition.

The treatment was well-tolerated, with no patients experiencing severe toxicity (≥ grade 3), and only mild genitourinary and gastrointestinal side effects were reported, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. Fan, CY., Chao, HL., Huang, WY., et al.[2017]

In a study of 149 patients with low- and favorable intermediate-risk prostate cancer, stereotactic body radiotherapy (SBRT) showed a 100% 3-year biochemical failure-free survival rate compared to 95.5% for moderate hypofractionation (hRT), indicating potentially better outcomes with SBRT.

Both treatment methods had similar safety profiles, with only one case of acute grade 3 urinary toxicity reported in the hRT group, suggesting that SBRT is a safe alternative with comparable efficacy to hRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate versus extreme hypofractionated radiotherapy: a toxicity comparative analysis in low- and favorable intermediate-risk prostate cancer patients. Nicosia, L., Mazzola, R., Rigo, M., et al.[2021]

In a study of 216 prostate cancer patients, those treated with ultrahypofractionated CyberKnife stereotactic radiotherapy (SBRT) experienced significantly lower rates of acute genitourinary (GU) and gastrointestinal (GI) toxicity compared to those receiving conventional radiotherapy (EBRT).

Specifically, 12% of patients in the SBRT group had grade 2 GU toxicity compared to 43% in the EBRT group, and 71% of SBRT patients reported no GI toxicity versus 44% in the EBRT group, indicating that SBRT may be a safer option for reducing acute side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrahypofractionated CyberKnifeTM based stereotactic radiotherapy versus conventional radiotherapy in patients with prostate cancer - acute toxicity evaluation in two phase II prospective studies. Głowacki, G., Majewski, W., Wojcieszek, P., et al.[2019]

In a study of 33 patients with low- and intermediate-risk prostate cancer treated with CyberKnife SBRT, there was no biochemical failure, indicating high efficacy of the treatment over a median follow-up of 51 months.

The treatment resulted in manageable side effects, with no grade 3 acute or late toxicities reported, and most acute complications resolved within 2 months, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic body radiotherapy in low- and intermediate-risk prostate carcinoma. Kim, HJ., Phak, JH., Kim, WC.[2022]

External-beam radiotherapy (EBRT) has been effectively used for over 30 years to treat prostate adenocarcinoma, demonstrating significant improvements in cause-specific survival and freedom from PSA progression.

Recent advancements in radiation techniques have enhanced the safety and efficacy of EBRT, making it a viable treatment option for early-stage, locally advanced, and metastatic prostate cancer, while managing side effects effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External-beam radiotherapy in the management of carcinoma of the prostate. Zlotecki, RA.[2017]

External beam radiotherapy (EBRT) is an effective treatment for relieving symptoms caused by bone metastases in prostate cancer patients.

This review specifically compares the effectiveness of single fraction radiotherapy to multiple fraction radiotherapy, highlighting the need for further analysis on which approach may provide better outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single fraction radiotherapy versus multiple fraction radiotherapy for bone metastases in prostate cancer patients: comparative effectiveness. Yoon, F., Morton, GC.[2020]

The CyberKnife (CK) technique for treating low- to intermediate-risk prostate cancer showed excellent dose delivery, with 95.8% of the prostate receiving the prescribed radiation dose, indicating effective targeting of the tumor while minimizing exposure to surrounding tissues.

Patients tolerated the CK monotherapy well, with stable urinary symptoms and mild bowel symptoms reported after treatment, suggesting a favorable safety profile during the initial follow-up period of 5.1 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic radiotherapy as monotherapy for low- to intermediate-stage prostate cancer: early experience, feasibility, and tolerance. Aluwini, S., van Rooij, P., Hoogeman, M., et al.[2016]

In a study of 12 localized prostate cancer cases, Tomotherapy (HT) demonstrated superior dosimetric results compared to Cyberknife (CK), achieving better dose homogeneity, target coverage, and conformity, which are crucial for effective treatment.

HT also predicted lower late rectal toxicity and resulted in a significantly lower integral dose to the body, suggesting that it may offer clinical benefits by reducing the risk of side effects associated with radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric and radiobiological comparison of Cyberknife and Tomotherapy in stereotactic body radiotherapy for localized prostate cancer. Chen, CY., Lee, LM., Yu, HW., et al.[2018]

In a study of 29 prostate cancer patients treated with stereotactic body radiotherapy (SBRT) using a Cyberknife, PSA levels showed a significant decrease over time, with a median nadir of 0.329 ng/mL achieved after 23 months.

The treatment demonstrated a favorable safety profile, with only 3% of patients experiencing Grade 2 urinary toxicities and no severe late rectal toxicities reported, indicating that SBRT is a feasible option for prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for prostate cancer: a preliminary report. Lee, YH., Son, SH., Yoon, SC., et al.[2022]

Citations

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Stereotactic body radiotherapy with CyberKnife® System ... Our study confirms that SBRT of 35–36.25 Gy in five fractions with the CyberKnife System produces excellent control with low toxicity in patients with low– ...

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Long-term Outcomes of Stereotactic Body Radiotherapy for ... This cohort study of pooled individual patient data assesses long-term outcomes after stereotactic body radiotherapy for low-risk and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6770993/

Stereotactic Body Radiation Therapy for Localized Prostate ... Prostate SBRT has substantial prospective evidence supporting its use, with favorable tumor control, patient-reported quality of life, and levels of toxicity ...

4. cancer.gov cancer.gov/news-events/cancer-currents-blog/2024/prostate-cancer-sbrt-effective-safe

SBRT Proves Effective for Some Prostate Cancers - NCI Trial participants who were randomly assigned to receive SBRT had a higher risk of developing some urinary problems over the first 2 years after ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405632424000209

Stereotactic body radiation therapy (SBRT) for prostate ... Prostate SBRT is generally associated with low rates of side effects, with toxicities similar to those of conventional RT [3], [4]. However, unlike conventional ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6484596/

Long-term Outcomes of Stereotactic Body Radiotherapy for ... Comparative analysis of efficacy and safety of radiation treatment options for low- and intermediate-risk prostate cancer.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301625034388

CyberKnife Stereotactic Body Radiation Therapy (SBRT ... This study describes a novel, safe, and low-toxicity radiation protocol for men with intermediate and high-risk prostate cancer, demonstrating that simultaneous ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11844808/

Current State of Stereotactic Body Radiation Therapy for ... A subsequent long-term update of that experience reported 5- and 10-year survival rates of 68% and 33%. In the more recent era, an early phase I/II trial from ...

9. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1270498/full

Stereotactic body radiotherapy with CyberKnife® System ... Results: The 1-, 2-, and 5-year DFS rates were 92.9%, 92.9%, and 92.3%, respectively, while the 1-, 2-, and 5-year bDFS rates were 100%, 100%, and 95.7%, ...

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Stereotactic body radiation therapy for prostate cancer—a ... A majority of the data thus far reporting the outcomes for patients undergoing prostate SBRT have received 35–36.25 Gy in 5 daily fractions, a dose that ...