SBRT with Urethral-Sparing IMRT for Prostate Cancer

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating prostate cancer using focused radiation therapy. The researchers aim to determine the optimal dose of stereotactic body radiation therapy, a precise, high-dose radiation, while minimizing harm to healthy tissues. Participants will receive radiation every other day for 10 days, aiming to reduce treatment time and side effects. Men with prostate cancer who have had a recent biopsy and meet specific prostate and health criteria may qualify for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to more effective prostate cancer treatments.

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.

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

Research has shown that stereotactic body radiation therapy (SBRT) is generally safe for treating prostate cancer. Studies have found that most patients tolerate this type of radiation therapy well, with severe side effects being rare. Most side effects, such as tiredness or skin irritation, are mild and temporary.

One study introduced a new SBRT method with low levels of severe reactions, resulting in fewer serious side effects. Patients with moderate to high-risk prostate cancer tolerated the treatment well. Another study demonstrated high survival rates, suggesting the treatment works effectively without causing major harm.

Overall, while some patients might experience mild side effects, serious problems are uncommon. These studies provide a reassuring view of SBRT's safety for prostate cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SBRT with urethral-sparing IMRT approach for prostate cancer due to its potential to minimize side effects while maintaining effectiveness. Unlike traditional radiation therapies, which can affect surrounding healthy tissues, this method uses precise targeting to protect the urethra, potentially reducing urinary side effects. The trial includes two arms: one with a uniform dose of SBRT and another with a slightly higher dose using a technique called Simultaneous Integrated Boost (SIB). The SIB approach may allow for a more concentrated dose directly to the tumor, potentially enhancing effectiveness without increasing overall treatment time.

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

Research has shown that stereotactic body radiation therapy (SBRT) effectively treats prostate cancer. Studies have found that SBRT provides excellent long-term control of the disease, particularly for patients with low- and intermediate-risk cancer. Patients typically experience low rates of side effects, comparable to those of standard radiation therapy. In this trial, participants will be assigned to one of two treatment arms: Arm A, receiving moderate dose SBRT with SIB, or Arm B, receiving uniform dose SBRT. SBRT delivers high doses of radiation directly to the tumor, targeting cancer cells while protecting healthy tissue. This makes it a promising treatment option for managing prostate cancer effectively. ^{4 6 7 8 9}

Who Is on the Research Team?

Zachary Morris, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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 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]

Citations

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Cyberknife Radioablation of Prostate Cancer Stereotactic ablative radiotherapy of low and intermediate risk prostate cancer patients is a safe, well-tolerated and effective treatment modality (2.25% of ...

2. 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 ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2723641

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 ...

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

and intermediate-risk prostate cancer: clinical outcomes ... Conclusion: 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 ...

5. redjournal.org redjournal.org/article/S0360-3016(24)03368-6/abstract

Stereotactic Radiation Therapy for Localized Prostate Cancer SABR shows excellent long-term disease control for low- and intermediate-risk localized prostate cancer. Patients treated for prostate cancer ...

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. cco.amegroups.org cco.amegroups.org/article/view/16080/html

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 ...