SBRT for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Hoag Memorial Hospital Presbyterian

Disqualifiers: Metastases, Lymph node involvement, Surgery, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1-2 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 Stereotactic Body Radiation Therapy (SBRT), which precisely targets the tumor. The goal is to evaluate SBRT's long-term effectiveness and monitor any side effects. The trial compares two systems, Agility and Elekta Versa HD, to identify differences in outcomes such as treatment success and quality of life. Men diagnosed with prostate cancer who have not undergone certain treatments, like prostate surgery or previous radiation, might be suitable candidates. Participants will contribute to understanding this treatment and its impact over five years. As an unphased trial, this study offers patients a unique opportunity to contribute to groundbreaking research that could shape future 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.

What prior data suggests that SBRT using the Elekta Versa or Agility System is safe for prostate cancer treatment?

Previous studies have shown that Stereotactic Body Radiation Therapy (SBRT) is well-tolerated for treating prostate cancer. Research indicates that SBRT maintains a good safety record, even for patients with more advanced stages of the disease. Most patients did not experience severe side effects, and serious side effects, known as Grade 3 toxicities, were rare.

The FDA has approved the Elekta Versa and Agility Systems for cancer treatment, confirming they meet safety standards for patient use. Studies have shown that these systems do not significantly affect survival rates compared to traditional radiation therapy. This supports the idea that SBRT is both effective and safe for treating prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Stereotactic Body Radiation Therapy (SBRT) for prostate cancer because it offers a more precise and targeted approach compared to traditional radiation therapies. Unlike conventional treatments, which often require multiple sessions over several weeks, SBRT can deliver higher doses of radiation in fewer sessions, potentially reducing treatment time and minimizing exposure to surrounding healthy tissues. The trial is particularly focused on using advanced systems like Agility and Elekta Versa HD, which help to closely monitor and adjust for any movement during treatment, aiming to improve accuracy and patient outcomes.

What evidence suggests that SBRT might be an effective treatment for prostate cancer?

Research has shown that Stereotactic Body Radiation Therapy (SBRT) effectively treats prostate cancer. Studies have found that SBRT controls the disease well and causes few serious side effects. In this trial, participants will receive SBRT using either the Agility Systems or the Elekta Versa HD machine. For patients using the Agility Systems, SBRT maintains a good quality of life and shows low rates of cancer recurrence at the molecular level over time. Similarly, SBRT with the Elekta Versa HD machine provides precise and quick treatment that is both effective and safe. Overall, SBRT offers a promising option for targeting prostate tumors while minimizing side effects. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for men over 18 with early to moderately advanced prostate cancer (stage T1-3) who haven't had previous treatments like surgery, cryosurgery, or radiation. They must be able to consent and fill out a quality of life questionnaire. Men with distant metastases, lymph node involvement, severe bowel disease, or prior chemotherapy are excluded.

Inclusion Criteria

My cancer is in an early to mid-stage, not the most advanced.

I have had a physical exam that included a prostate check.

I am a man aged 18 or older.

Exclusion Criteria

My cancer has spread to distant parts of my body.

Performance Status will not be considered

There are no restrictions based on your life expectancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Stereotactic Body Radiation Therapy (SBRT) using Elekta Versa or Agility Systems over 5 treatments

1-2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for biochemical failure rates and quality of life data for 5 years following SBRT

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

Trial Overview The study tests the effectiveness and side effects of Stereotactic Body Radiation Therapy (SBRT) using Elekta Versa or Agility Systems in treating prostate cancer. SBRT is an advanced technique delivering targeted radiation in fewer sessions compared to traditional therapy—5 versus 42-45 treatments.

How Is the Trial Designed?

Group I: Agility Systems Experimental Treatment 1 Intervention

This study seeks to investigate biochemical failure rates for patients treated with SBRT utilizing Agility Systems, as well as obtain quality of life data and assess the intrafraction motion in approximately 15 patients for 5 years following SBRT.

Group II: Elekta Versa HD Active Control 1 Intervention

This study seeks to investigate biochemical failure rates for patients treated with SBRT utilizing Elekta machines, as well as obtain quality of life data and assess the intrafraction motion in approximately 15 patients for 5 years following SBRT.

Who Is Running the Clinical Trial?

Hoag Memorial Hospital Presbyterian

Lead Sponsor

Trials

37

Recruited

17,200+

Published Research Related to This Trial

Stereotactic body radiotherapy (SBRT) for localized prostate cancer shows promising results, with studies indicating that ultra-hypofractionated schedules (like 42.7 Gy in 7 fractions) are non-inferior to standard treatments in terms of 5-year biochemical recurrence-free survival and have similar tolerability.

Current evidence suggests that two-fraction SBRT may be the shortest effective treatment schedule, but caution is advised against single-fraction SBRT due to concerns about inferior efficacy, highlighting the need for ongoing trials to determine optimal fractionation schedules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The march toward single-fraction stereotactic body radiotherapy for localized prostate cancer-Quo Vadimus? Ong, WL., Loblaw, A.[2023]

Stereotactic body radiotherapy (SBRT) is shown to be safe and effective for treating node-positive prostate cancer, with a median follow-up of 30 months revealing no severe gastrointestinal toxicities and manageable genitourinary side effects.

In a study of 60 patients, SBRT resulted in a 3-year overall survival rate of 89% and a biochemical failure-free survival rate of 77%, indicating promising long-term outcomes even in patients with advanced disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. Telkhade, T., Murthy, V., Kanala, TS., et al.[2021]

In a study of 713 men treated with stereotactic body radiation therapy (SBRT) for localized prostate cancer, only 3% to 4% experienced significant long-term declines in health-related quality of life (HRQOL), indicating that SBRT has minimal long-term negative effects on overall well-being.

Factors such as lower baseline bowel HRQOL and depression were found to predict declines in HRQOL, suggesting that comorbid conditions may play a larger role in patient outcomes than the treatment itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of multidomain decline in health-related quality of life after stereotactic body radiation therapy (SBRT) for prostate cancer. Dess, RT., Jackson, WC., Suy, S., et al.[2022]

In a prospective phase II trial involving 110 patients aged 70 and older with localized prostate cancer, stereotactic body radiotherapy (SBRT) demonstrated a severe toxicity rate of less than 5%, confirming its safety for this patient population.

The SBRT regimen resulted in a biochemical progression-free survival (bPFS) rate of 90% over a median follow-up of 36 months, indicating its efficacy in treating localized prostate cancer without negatively impacting patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial. Nguyen, P., Harzée, L., Retif, P., et al.[2022]

In a study of 174 hormone-naïve patients with localized prostate cancer treated with stereotactic body radiation therapy (SBRT), significant urinary symptoms were reported more frequently than bowel symptoms, with 51.6% of patients experiencing a clinically significant decline in urinary scores at 12 months.

The study indicates that while urinary and bowel symptoms initially increased after treatment, the proportion of patients reporting significant declines in these symptoms decreased from 12 to 36 months, suggesting potential late improvements in quality of life following SBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Prostate Cancer: What is the Appropriate Patient-Reported Outcome for Clinical Trial Design? Woo, JA., Chen, LN., Wang, H., et al.[2020]

In a study of 26 patients with low- or intermediate-risk prostate adenocarcinoma, stereotactic body radiation therapy (SBRT) showed excellent biochemical control with no observed failures after a median follow-up of 59.5 months.

The treatment resulted in manageable late toxicity, with only 11.5% of patients experiencing significant genitourinary or gastrointestinal side effects, and patient-reported quality of life remained stable compared to pre-treatment levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate Stereotactic Body Radiation Therapy With a Focal Simultaneous Integrated Boost: 5-Year Toxicity and Biochemical Recurrence Results From a Prospective Trial. Maas, JA., Dobelbower, MC., Yang, ES., et al.[2023]

Stereotactic body radiotherapy (SBRT) for localized prostate cancer showed a 5-year biochemical relapse-free survival (bRFS) rate of 93% across 1100 patients, indicating its effectiveness as a treatment option.

The study found no significant differences in outcomes based on the use of androgen deprivation therapy or total radiation dose, suggesting that SBRT is a robust treatment regardless of these factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for localized prostate cancer: pooled analysis from a multi-institutional consortium of prospective phase II trials. King, CR., Freeman, D., Kaplan, I., et al.[2022]

Stereotactic body radiation therapy (SBRT) for localized prostate cancer showed similar 5-year survival rates (90.8% for SBRT vs. 88.1% for IMRT) and comparable freedom from biochemical failure (FFBF) rates, indicating its efficacy is on par with intensity-modulated radiation therapy (IMRT).

Both treatment methods had low toxicity, with no severe (grade 3 or higher) side effects reported, suggesting that SBRT is a safe alternative that offers the benefits of shorter treatment duration and lower costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propensity score matched comparison of SBRT versus IMRT for the treatment of localized prostate cancer. Oliai, C., Bernetich, M., Brady, L., et al.[2022]

In a phase I/II study involving 91 patients with localized prostate cancer, stereotactic body radiation therapy (SBRT) demonstrated a remarkable prostate-specific antigen (PSA) control rate of 99% over a median follow-up of 42 months.

While the maximum-tolerated dose (MTD) was not reached, the study noted a concerning 10.6% incidence of high-grade rectal toxicity at the highest dose level of 50 Gray, prompting the need for dose constraints to reduce this risk in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Prostate Cancer: Review of Experience of a Multicenter Phase I/II Dose-Escalation Study. Kim, DW., Straka, C., Cho, LC., et al.[2022]

In a study of 304 prostate cancer patients treated with CyberKnife stereotactic body radiotherapy (SBRT), the treatment demonstrated excellent biochemical control rates, with 97% of low-risk, 90.7% of intermediate-risk, and 74.1% of high-risk patients remaining free from biochemical recurrence at 5 years.

The treatment was associated with low toxicity, as no patients experienced severe acute complications, and only a small percentage had Grade II urinary or rectal toxicities, indicating that SBRT is a safe and effective option for prostate cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for localized prostate cancer: disease control and quality of life at 6 years. Katz, AJ., Santoro, M., Diblasio, F., et al.[2021]

Between 2006 and 2020, there was a significant increase in publications and citations related to stereotactic body radiotherapy (SBRT) for prostate cancer, indicating growing interest and research in this treatment method.

The United States led the research output in this field, with a focus on SBRT applications in oligometastatic disease, reirradiation, and salvage therapy, highlighting key areas for future investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy for Prostate Cancer: Where, When, and Who? A Bibliometric Analysis. Viani, GA., Gouveia, AG., Jacinto, AA., et al.[2023]

Stereotactic body radiation therapy (SBRT) for localized prostate cancer showed a high two-year biochemical relapse-free survival rate of 99%, indicating its efficacy in controlling the disease.

The treatment was well tolerated, with low rates of gastrointestinal (1%) and genitourinary (31%) toxicities, and most patients who were sexually potent before treatment maintained their potency two years later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer: the Georgetown University experience. Chen, LN., Suy, S., Uhm, S., et al.[2022]

Stereotactic body radiotherapy (SBRT) shows a high local control rate of 98.1% in treating oligorecurrent prostate cancer limited to lymph nodes, based on a systematic review of 363 patients across nine studies with a median follow-up of 19.23 months.

The treatment demonstrated a low incidence of toxicity, with only 5.6% of patients experiencing grade ≥2 adverse effects, and no cases of grade 4 toxicity, suggesting that SBRT is a safe option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring All Avenues for Radiotherapy in Oligorecurrent Prostate Cancer Disease Limited to Lymph Nodes: A Systematic Review of the Role of Stereotactic Body Radiotherapy. Ponti, E., Lancia, A., Ost, P., et al.[2022]

Citations

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Stereotactic Body Radiation Therapy for Localized Prostate ... We demonstrate that prostate SBRT provides excellent disease control, favorable patient-reported quality of life and results in minimal serious acute or late ...

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

Stereotactic body radiation therapy (SBRT) for prostate ... However, the authors concluded that SBRT is effective in treating prostate tumors without serious toxicity and regardless the treatment modality.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03889119

Stereotactic Body Radiation Therapy (SBRT) for Prostate ... This study seeks to investigate biochemical failure rates for patients treated with SBRT utilizing Agility Systems, as well as obtain quality of life data and ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.323

Long-term treatment outcomes from the International Multi ... Conclusions: The safety and efficacy profile of SBRT for high-risk prostate cancer remains favorable at long-term follow-up.

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

SBRT Proves Effective for Some Prostate Cancers - NCI Over the 5 years of follow-up, a total of 27% of men in the SBRT group and 18% in the standard radiation therapy group reported urinary problems ...

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/pii/S2773160X25000078

The effectiveness and safety of stereotactic body ... The results show minor, non-significant differences in survival rates compared to conventional fractionation, a type of external radiation, after two and five ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7350884/

Stereotactic Body Radiation Therapy (SBRT) for Prostate ... Conclusions: SBRT for clinically localized prostate cancer was well-tolerated in men with baseline IPSS ≥ 15 (1). Grade 3 toxicities occurred ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1879850023002370

Stereotactic Body Radiation Therapy: A Radiosurgery ... External beam radiation therapy (RT) is a safe and effective curative treatment modality for men with localized prostate cancer (PCa). While traditionally ...