Shorter vs Usual Radiation Therapy for Prostate Cancer

Recruiting at 280 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: NRG Oncology

Must be taking: Androgen deprivation therapy

Disqualifiers: Metastatic disease, Prior prostatectomy, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.

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.

What data supports the effectiveness of the treatment External Beam Radiation Therapy (EBRT) and Stereotactic Body Radiation Therapy (SBRT) for prostate cancer?

Research shows that External Beam Radiation Therapy (EBRT) has been effective in treating prostate cancer for over 30 years, improving survival and reducing cancer progression. Additionally, Stereotactic Body Radiation Therapy (SBRT) using the CyberKnife system has shown promising results in treating low- to high-risk prostate cancer, indicating its potential effectiveness. ^{1 2 3 4 5}

Is shorter radiation therapy for prostate cancer safe?

Research shows that shorter radiation therapy using CyberKnife for prostate cancer generally has lower rates of acute side effects compared to conventional radiation. Most patients experience mild to moderate side effects, with fewer severe reactions. ^{1 4 6 7 8}

How is the treatment of shorter vs usual radiation therapy for prostate cancer different from other treatments?

This treatment uses a shorter course of radiation therapy, specifically Stereotactic Body Radiation Therapy (SBRT), which delivers high doses of radiation in fewer sessions compared to traditional methods. This approach can be more convenient and may reduce the overall treatment time while maintaining effectiveness. ^{2 3 4 9 10}

Research Team

Karen E Hoffman

Principal Investigator

NRG Oncology

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• External Beam Radiation Therapy (Radiation)
• Stereotactic Body Radiation Therapy (Radiation)

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.

Participant Groups

Group I: Arm I (SBRT) Experimental Treatment 5 Interventions

Patients undergo SBRT for a total of 5 treatments over 2 weeks. Patients also undergo CT and/or MRI on study.

Group II: Arm II (EBRT) Active Control 5 Interventions

Patients undergo EBRT for 20 to 45 treatments over 4 to 9 weeks. Patients also undergo CT and/or MRI on study.

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

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+

Findings from Research

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]

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]

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 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]

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 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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for prostate cancer: a preliminary report. [2022]

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

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

3. New Zealand pubmed.ncbi.nlm.nih.gov

Single fraction radiotherapy versus multiple fraction radiotherapy for bone metastases in prostate cancer patients: comparative effectiveness. [2020]

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

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic body radiotherapy in low- and intermediate-risk prostate carcinoma. [2022]

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

CyberKnife stereotactic radiotherapy as monotherapy for low- to intermediate-stage prostate cancer: early experience, feasibility, and tolerance. [2016]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Dosimetric and radiobiological comparison of Cyberknife and Tomotherapy in stereotactic body radiotherapy for localized prostate cancer. [2018]

8. Slovakia 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. [2019]

9. Italy pubmed.ncbi.nlm.nih.gov

Oncologic outcome of salvage high-intensity focused ultrasound (HIFU) in radiorecurrent prostate cancer. A systematic review. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Moderate versus extreme hypofractionated radiotherapy: a toxicity comparative analysis in low- and favorable intermediate-risk prostate cancer patients. [2021]