42 Participants Needed

SBRT for Prostate Cancer

KR
TC
TC
DN
DN
Overseen ByDebbie-Ann N Nathan, R.N.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.13678

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.136910

Who Is on the Research Team?

KR

Krishnan R Patel, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

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
My prostate cancer is located in one spot, confirmed by MRI and PET scans.
See 2 more

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
See 20 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • 18F-DCFPyL
  • Stereotactic Body Radiation Therapy
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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: 1/Focal SBRTExperimental Treatment2 Interventions

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

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Approved in United States as Stereotactic Body Radiation Therapy for:
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Approved in European Union as Stereotactic Body Radiation Therapy for:
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Approved in Canada as Stereotactic Body Radiation Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

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

Citations

Stereotactic body radiotherapy for prostate cancer: a preliminary report. [2022]
Cyberknife, Helical Tomotherapy and Rapid Arc SIB-SBRT Treatment Plan Comparison for Carcinoma Prostate. [2021]
Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. [2018]
Hypofractionated stereotactic body radiotherapy in low- and intermediate-risk prostate carcinoma. [2022]
Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]
Stereotactic Ablative Radiotherapy Using CyberKnife for Stage I Non-small-cell Lung Cancer: A Retrospective Analysis. [2022]
Stereotactic Body Radiotherapy for Low-Risk Prostate Cancer: A Ten-Year Analysis. [2020]
Image-guided stereotactic body radiation therapy for localized prostate cancer. [2022]
CyberKnife radiosurgery for prostate cancer. [2022]
Current role of image-guided robotic radiosurgery (Cyberknife(®) ) for prostate cancer treatment. [2018]
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