SBRT with Urethral-Sparing IMRT for Prostate Cancer

Recruiting at 2 trial locations

Overseen By Cancer Connect

Age: Any Age

Sex: Male

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must be taking: Androgen deprivation

Disqualifiers: Invasive malignancy, Pelvic implants, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

115 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I/II trial studies the side effects and best dose of stereotactic body radiation therapy while using intensity-modulated radiation therapy (IMRT) planning to help avoid radiation to normal tissue in patients with prostate cancer. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using small, high doses of radiation over several days and may cause less damage to normal tissue. This treatment schedule allows for a higher dose of radiation to be administered over a shorter overall treatment period in comparison to standard radiation therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment SBRT with Urethral-Sparing IMRT for Prostate Cancer?

Research shows that using CyberKnife for stereotactic body radiation therapy (SBRT) in prostate cancer treatment has promising outcomes with minimal side effects. Studies indicate that this approach is effective for both low-risk and more advanced prostate cancer, suggesting it could be a beneficial treatment option. ^{1 2 3 4 5}

Is SBRT with Urethral-Sparing IMRT for Prostate Cancer safe for humans?

Research on stereotactic ablative radiotherapy (SABR) using the CyberKnife system for prostate cancer shows it is generally safe, with very few severe side effects reported. In studies, only a small percentage of patients experienced significant genitourinary or gastrointestinal reactions, and no severe long-term adverse effects were observed. ^{2 5 6 7 8}

How is SBRT with urethral-sparing IMRT different from other prostate cancer treatments?

SBRT with urethral-sparing IMRT is unique because it combines precise, high-dose radiation (SBRT) with a focus on protecting the urethra, potentially reducing side effects compared to conventional treatments. This approach allows for fewer treatment sessions, which can be more convenient for patients. ^{2 4 9 10 11}

Research Team

Zachary Morris, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for men with prostate cancer confirmed by a biopsy within the last 180 days, Gleason score ≤7 without aggressive patterns, clinical stage ≤T2b, PSA ≤20 ng/ml. Participants should have good performance status (able to carry out daily activities) and no severe urinary blockage or active infections. Men who've had certain other cancers in the past 5 years or specific treatments for prostate cancer aren't eligible.

Inclusion Criteria

My prostate cancer was confirmed by a biopsy within the last 6 months.

I have had a prostate exam in the last 90 days.

Participant signs study specific informed consent prior to study enrollment

Exclusion Criteria

I have scleroderma.

FOR ARM A: Inability to obtain a planning MRI or a planning MRI of sufficient quality to allow identification of the peripheral zone and urethra, or inability to adequately fuse the MRI to the planning CT scan

You have a serious health condition that is currently active and may interfere with your ability to participate in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 5 fractions of SBRT with either moderate or uniform dose every other day for 10 days following urethral-sparing IMRT planning

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Follow-up at 4-8 weeks, at 4, 8, and 12 months, every 4 months for 1 year, every 6 months for 3 years, and then every 12 months thereafter

Treatment Details

Interventions

• Radiation Therapy Treatment Planning and Simulation
• Stereotactic Body Radiation Therapy

Trial Overview The trial is testing high-dose stereotactic body radiation therapy using IMRT planning to minimize damage to normal tissue in prostate cancer patients. It aims to find the best dose that's effective while sparing healthy tissue like the urethra, delivering treatment over fewer days compared to standard therapy.

Participant Groups

Group I: Arm A (moderate dose SBRT with SIB) Experimental Treatment 2 Interventions

Patients undergo 5 fractions of moderate dose SBRT with SIB every other day for 10 days following urethral-sparing IMRT planning. SBRT: 8.0Gy escalated dose

Group II: Arm B (uniform dose SBRT) Active Control 2 Interventions

Patients undergo 5 fractions of uniform dose SBRT every other day for 10 days following urethral-sparing IMRT planning. SBRT: 7.5Gy conventional dose

Stereotactic Body Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Non-small cell lung cancer (NSCLC)
• Melanoma
• Renal cell carcinoma (RCC)
• Prostate cancer
• Oligoprogressive cancers

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Findings from Research

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]

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]

Recent data indicate that CyberKnife SBRT (Stereotactic Body Radiation Therapy) for prostate cancer shows promising treatment outcomes with minimal toxicity, suggesting it could be a safe and effective option.

Despite ongoing controversy in the radiation oncology community, the radiobiologic characteristics of the prostate make it a strong candidate for SBRT, highlighting the need for further evaluation and acceptance of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife radiosurgery for prostate cancer. Katz, AJ.[2022]

In a multicenter trial involving 165 prostate cancer patients, 31% experienced major protocol deviations during stereotactic body radiation therapy (SBRT), with deviations occurring more frequently in the intensity modulated radiation therapy (IMRT) group compared to volumetric modulated arc therapy (VMAT).

VMAT demonstrated superior dosimetric outcomes compared to IMRT, including better dose distribution to the urethra and reduced exposure to the bladder, indicating that VMAT may be a safer and more effective option for delivering SBRT in localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urethra-Sparing Stereotactic Body Radiation Therapy for Prostate Cancer: Quality Assurance of a Randomized Phase 2 Trial. Jaccard, M., Zilli, T., Dubouloz, A., et al.[2021]

In a study of 84 low-risk prostate cancer patients treated with Stereotactic Ablative Body Radiotherapy (SABR), long-term quality of life (QOL) outcomes were generally positive, with a median follow-up of 50.8 months, although some patients reported declines in urinary (17.9%), bowel (26.2%), and sexual (37.5%) QOL domains.

Dosimetric factors such as rectal D1cc and penile bulb V35 were identified as significant predictors of worse QOL, highlighting the importance of adhering to strict dosimetric constraints to minimize side effects from treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. Elias, E., Helou, J., Zhang, L., et al.[2018]

In a study of 70 patients with nonmetastatic prostate cancer treated with stereotactic body radiation therapy (SBRT), CyberKnife showed significantly lower peak acute genitourinary (GU) toxicity compared to volumetric-modulated arc therapy (VMAT), with IPSS scores of 16.2 versus 20.2, respectively.

The incidence of grade 2 acute GU toxicity was lower in the CyberKnife group (22.9%) compared to the VMAT group (45.7%), suggesting that CyberKnife may be a safer option for minimizing acute prostate symptoms during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for prostate cancer: a study comparing 3-year genitourinary toxicity between CyberKnife and volumetric-modulated arc therapy by propensity score analysis. Ito, M., Yoshioka, Y., Takase, Y., et al.[2023]

Stereotactic ablative radiotherapy (SABR) is a safe and effective treatment for low and intermediate risk prostate cancer, with only a 2.25% failure rate observed in a study of 400 patients over a median follow-up of 15 months.

The treatment resulted in a significant decline in prostate-specific antigen (PSA) levels, with no severe late adverse effects reported, indicating that SABR could be considered for more advanced cases of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cyberknife Radioablation of Prostate Cancer – Preliminary Results for 400 Patients Miszczyk, L., Namysł Kaletka, A., Napieralska, A., et al.[2020]

Stereotactic ablative radiation (SAbR) at a dose of 45 Gy in 5 fractions shows a promising safety profile for treating localized prostate cancer, with acute urinary and gastrointestinal toxicity rates of 20.4% and 7.3%, respectively, and low rates of late toxicity after 2 years.

The treatment demonstrated excellent efficacy, with a biochemical failure-free survival rate of 100% at 1 year and 98.7% at 2 years, indicating strong disease control outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. Chen, L., Gannavarapu, BS., Desai, NB., et al.[2022]

In a study of 170 prostate cancer patients, urethra-sparing stereotactic body radiotherapy (SBRT) demonstrated a low toxicity profile, with less than 5% experiencing grade 2 or higher genitourinary and less than 2% gastrointestinal toxicity at 18 months.

Both treatment schedules (every other day and once a week) resulted in favorable biochemical control rates, with only four cases of biochemical failure, indicating that the treatment is effective regardless of the frequency of administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-a-week or every-other-day urethra-sparing prostate cancer stereotactic body radiotherapy, a randomized phase II trial: 18 months follow-up results. Zilli, T., Jorcano, S., Bral, S., et al.[2021]

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]

Stereotactic body radiation therapy (SBRT) resulted in significantly lower post-treatment PSA levels compared to intensity-modulated radiation therapy (IMRT) at 2 and 3 years, indicating better efficacy in controlling prostate cancer.

Both SBRT and IMRT showed similar overall survival rates after 5 years, but SBRT offers advantages such as lower cost and easier application, making it a suitable alternative for treating localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Stereotactic body radiation therapy versus conventional intensity-modulated radiation therapy for the treatment of prostate cancer]. Gao, QN.[2022]

References

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

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

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

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

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

CyberKnife radiosurgery for prostate cancer. [2022]

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

Urethra-Sparing Stereotactic Body Radiation Therapy for Prostate Cancer: Quality Assurance of a Randomized Phase 2 Trial. [2021]

5. Ireland pubmed.ncbi.nlm.nih.gov

Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for prostate cancer: a study comparing 3-year genitourinary toxicity between CyberKnife and volumetric-modulated arc therapy by propensity score analysis. [2023]

7. Thailand pubmed.ncbi.nlm.nih.gov

Cyberknife Radioablation of Prostate Cancer – Preliminary Results for 400 Patients [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. [2022]

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

Once-a-week or every-other-day urethra-sparing prostate cancer stereotactic body radiotherapy, a randomized phase II trial: 18 months follow-up results. [2021]

10. Australia pubmed.ncbi.nlm.nih.gov

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

11. China pubmed.ncbi.nlm.nih.gov

[Stereotactic body radiation therapy versus conventional intensity-modulated radiation therapy for the treatment of prostate cancer]. [2022]