SBRT for Prostate Cancer

Overseen By Comron Hassanzadeh, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must be taking: Androgen deprivation therapy

Disqualifiers: Scleroderma, Lupus, Prior prostatectomy, 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: 5

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of stereotactic body radiation therapy (SBRT) for treating advanced or high-risk prostate cancer. SBRT delivers targeted radiation in five short sessions over two weeks. It is intended for individuals with a confirmed diagnosis of prostate cancer, meeting specific criteria such as a certain Gleason grade and no distant cancer spread. Participants should not have undergone previous prostate surgeries or radiation that would overlap with the trial's treatment area. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on androgen deprivation therapy (ADT), you may continue as long as it started within 185 days before registration.

Is there any evidence suggesting that stereotactic body radiation therapy is likely to be safe for humans?

Research has shown that stereotactic body radiation therapy (SBRT) is generally safe and well-tolerated for treating prostate cancer. Studies have found that this type of radiation treatment usually causes only minor side effects. For example, one study found that only 2.25% of patients experienced significant issues.

SBRT appears to be as effective as other standard radiation methods, with only small differences in patient outcomes. Long-term research also suggests that SBRT remains effective over time, with high rates of survival and disease control.

These findings indicate that SBRT is a promising and relatively safe option for prostate cancer treatment. However, individual experiences can vary, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Stereotactic Body Radiation Therapy (SBRT) is unique because it delivers high doses of radiation with pinpoint precision, targeting prostate cancer cells while sparing surrounding healthy tissue. Unlike traditional radiation therapy, which can take several weeks, SBRT completes treatment in just five sessions over two weeks. This shorter schedule not only offers convenience but also reduces overall exposure to radiation, potentially minimizing side effects. Researchers are excited about SBRT because it could improve patient quality of life while maintaining effectiveness in combating prostate cancer.

What evidence suggests that stereotactic body radiation therapy might be an effective treatment for prostate cancer?

Research shows that stereotactic body radiation therapy (SBRT), which participants in this trial will receive, effectively treats prostate cancer. Studies have found that SBRT provides excellent long-term control for patients with low- and intermediate-risk prostate cancer. In these studies, patients received high doses of radiation in just a few sessions, which effectively controlled the cancer. Evidence suggests that SBRT can be as effective as, or even better than, standard radiation therapy in managing prostate cancer. This treatment has been used safely, with only minor differences in survival rates compared to traditional methods. Overall, SBRT is a promising and safe option for treating prostate cancer. ^{2 3 6 7 8}

Who Is on the Research Team?

Comron Hassanzadeh, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for men over 18 with advanced or high-risk prostate cancer that hasn't spread to other parts of the body. They should have a certain level of physical fitness (ECOG 0-2) and a specific grade of tumor severity (Gleason Grade Group 2-5). Prior hormone treatment for prostate cancer is okay if it started less than about six months ago.

Inclusion Criteria

My cancer is at a stage that can be treated but has not spread extensively.

I can take care of myself and perform daily activities.

My prostate cancer was confirmed by a lab test within the last year.

Exclusion Criteria

My cancer has spread and cannot be completely treated.

I've had radiation in the same area as my current cancer.

I have had surgery or cryosurgery for prostate cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive stereotactic body radiation therapy (SBRT) over 5 sessions, 2-3 times per week, for 2 weeks

2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, 12, and 24 months post-treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiation Therapy

Trial Overview The PRORAD-5 study tests how safe and effective Stereotactic Body Radiation Therapy (SBRT) is in treating advanced prostate cancer. SBRT delivers precise, high-dose radiation to the tumor in fewer sessions compared to traditional therapy.

How Is the Trial Designed?

Group I: Stereotactic Body Radiation Therapy Experimental Treatment 1 Intervention

Participants will then be scheduled to receive radiation therapy. Radiation will be given over 5 sessions, 2-3 times per week, for 2 weeks. Each radiation therapy session will take 15-30 minutes to complete. Within 1 day after completing radiation therapy, blood (about 2 tablespoons) will be drawn for routine tests.

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?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

Stereotactic body radiation therapy (SBRT) using CyberKnife for localized prostate cancer was found to be safe, with no severe treatment-related toxicities (grade 3 or higher) reported among 44 patients over a median follow-up of 40 months.

The treatment showed excellent efficacy, with a 100% cause-specific survival rate and progression-free survival rate, and a high biochemical failure-free rate of 90.8% for high-risk patients, particularly with the 34 Gy in 4 fractions regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided stereotactic body radiation therapy for localized prostate cancer. Kang, JK., Cho, CK., Choi, CW., et al.[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]

In a study of 230 men with early low-risk prostate cancer treated with stereotactic body radiotherapy (SBRT), the ten-year biochemical disease-free survival rate was an impressive 93%, indicating high efficacy of this treatment.

The treatment showed low toxicity, with only 10% of patients experiencing mild late urinary toxicity and 4% with late rectal toxicity, while quality of life scores for bowel and urinary function returned to baseline after initial declines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy for Low-Risk Prostate Cancer: A Ten-Year Analysis. Katz, A.[2020]

Stereotactic ablative radiotherapy (SABR) using Cyberknife demonstrated high effectiveness in treating stage I non-small-cell lung cancer, with 2-year local control, progression-free, and overall survival rates of 91.9%, 61.7%, and 84.8%, respectively, based on a study of 153 patients.

The treatment was generally safe, with only 8.1% of patients experiencing severe toxicities, including one case of grade 5 radiation pneumonitis, indicating that while SABR is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. Hayashi, K., Suzuki, O., Shiomi, H., 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]

In a study comparing three radiotherapy techniques for prostate cancer treatment, RapidArc (RA) demonstrated superior target dose distribution and better sparing of critical structures compared to Cyberknife (CK) and Helical Tomotherapy (HT).

RA also had a better conformity index and gradient index, while CK required significantly more monitor units and beam-on time, indicating it may be less efficient than RA for delivering the same treatment margins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cyberknife, Helical Tomotherapy and Rapid Arc SIB-SBRT Treatment Plan Comparison for Carcinoma Prostate. T K, B., K M, G., A, P., et al.[2021]

A single session of stereotactic ablative body radiotherapy (SABR) for oligometastatic prostate cancer was found to be feasible and safe, with only one significant adverse event (a vertebral fracture) reported among 33 patients over a 2-year follow-up period.

The treatment resulted in high local progression-free survival rates of 97% at 1 year and 93% at 2 years, with nearly half of the patients (48%) avoiding the need for androgen deprivation therapy at the 2-year mark, indicating effective disease control and maintained quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. Siva, S., Bressel, M., Murphy, DG., et al.[2022]

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]

The Cyberknife® system, used for stereotactic body radiation therapy (SBRT), shows promising efficacy in treating localized prostate cancer, with median PSA levels dropping significantly after treatment and biochemical progression-free survival rates ranging from 78.3% to 100% over a follow-up period of 4 to 60 months.

While the treatment is associated with mostly mild side effects (grade 1/2), there are reports of erectile dysfunction and some grade 3 toxicities, indicating a need for further long-term studies and randomized trials to establish its safety and effectiveness as a standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current role of image-guided robotic radiosurgery (Cyberknife(®) ) for prostate cancer treatment. Seisen, T., Drouin, SJ., Phé, V., 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

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10660677/

Stereotactic body radiotherapy with CyberKnife® System ... A total of 122 patients with low- and intermediate-risk prostate cancer were treated with the CyberKnife System at a dose of 35 Gy or 36.25 Gy in five fractions ...

2. 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 ...

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

SBRT Proves Effective for Some Prostate Cancers - NCI But it had to be confirmed that a 5-day course of SBRT was not worse at controlling cancer than standard radiation therapy and also that it does ...

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

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

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5494208/

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 ...

7. 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%, ...

8. thegreenjournal.com thegreenjournal.com/issue/S0167-8140(25)X0003-7?pageStart=26

May 2025 940 PERSIAN TRIAL (NCT03449719): Apalutamide and stereotactic body radiation therapy in patients affected by hormone-sensitive prostate cancer.