SBRT for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Krishnan R Patel, M.D.

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: National Cancer Institute (NCI)

Must not be taking: Investigational agents, Chemotherapy

Disqualifiers: High-risk prostate cancer, Metastases, HIV, Hepatitis, others

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial investigates a new radiation treatment called SBRT for men with early-stage prostate cancer. SBRT uses small gold seeds and advanced imaging to precisely target and kill cancer cells while minimizing damage to healthy tissue. The goal is to provide an effective treatment with fewer side effects compared to traditional methods. SBRT is a newer radiotherapy method for prostate cancer, developed to deliver high doses of radiation with improved precision.

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 systemic Androgen Deprivation Therapy (ADT) or chemotherapy, you cannot participate in the trial.

What data supports the effectiveness of the treatment SBRT for Prostate Cancer?

Research shows that Stereotactic Ablative Radiotherapy (SABR) using the CyberKnife system is promising for treating prostate cancer, especially for low- to intermediate-risk cases. Early results suggest it is effective and safe, but more long-term data on quality of life is needed. ^{1 2 3 4 5}

Is stereotactic body radiation therapy (SBRT) using CyberKnife safe for prostate cancer?

Studies have shown that stereotactic body radiation therapy (SBRT) using CyberKnife is generally safe for treating prostate cancer, with research focusing on its safety and feasibility for both low-risk and more advanced cases. ^{1 5 6 7 8}

How is the treatment SBRT for prostate cancer different from other treatments?

SBRT (Stereotactic Body Radiation Therapy) for prostate cancer is unique because it uses precise, high-dose radiation delivered in fewer sessions, often with the help of a robotic system like CyberKnife. This approach targets the cancer more accurately, potentially reducing damage to surrounding healthy tissue and minimizing side effects compared to traditional radiation therapy. ^{1 4 5 9 10}

Research Team

Krishnan R Patel, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

This trial is for men aged 18+ with untreated localized prostate cancer that hasn't spread outside the gland. They must be able to consent, have a performance status indicating they can carry out daily activities, and agree to use effective contraception during and up to 120 days post-treatment. Exclusions include those planning other treatments like ADT or chemotherapy, with high-risk prostate cancer features, prior curative treatment for prostate cancer, certain infections unless treated and cured, or conditions preventing MRI scans.

Inclusion Criteria

I can take care of myself but might not be able to do active work.

Ability of individual to understand and the willingness to sign a written informed consent document

I am 18 years old or older.

Exclusion Criteria

Participants with an AUA-SI/IPSS score > 18

I have had treatment aimed at curing my prostate cancer before.

Active urinary tract infection assessed by urinalysis

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive focal SBRT in two sessions, one week apart, targeting the prostate tumor

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with repeat scans and blood tests

24 months

Regular visits at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months

Biopsy Assessment

A biopsy is conducted to assess the impact of the treatment on prostate cancer

At 24 months

Treatment Details

Interventions

• 18F-DCFPyL (Diagnostic Agent)
• Stereotactic Body Radiation Therapy (Radiation)

Trial Overview The trial tests focal therapy using SBRT on patients with a single tumor in the prostate. It aims to see if this targeted radiation approach leads to fewer side effects than whole-gland surgery or radiation. Participants will undergo two sessions of SBRT about one week apart without sedation and follow-up for two years including scans (MRI & PSMA PET/CT) and blood tests.

Participant Groups

Group I: 1/Focal SBRT Experimental Treatment 2 Interventions

Focal SBRT to the tumor focus within the prostate, with response assessed by biopsy and imaging, including 18F-DCFPyL PET/CT.

Stereotactic Body Radiation Therapy is already approved in Canada for the following indications:

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?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

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]

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]

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 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]

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]

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]

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]

References

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

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

2. Thailand pubmed.ncbi.nlm.nih.gov

Cyberknife, Helical Tomotherapy and Rapid Arc SIB-SBRT Treatment Plan Comparison for Carcinoma Prostate. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

6. Greece pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022]

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

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

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

Image-guided stereotactic body radiation therapy for localized prostate cancer. [2022]

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

CyberKnife radiosurgery for prostate cancer. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Current role of image-guided robotic radiosurgery (Cyberknife(®) ) for prostate cancer treatment. [2018]