SBRT for Localized Prostate Cancer Post-Surgery

Not currently recruiting at 1 trial location

Overseen By Amar Kishan, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Distant metastases, N1 prostate cancer, Neuroendocrine carcinoma, Prior pelvic radiotherapy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks for SBRT, 6 months for ADT

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a focused radiation treatment, called stereotactic body radiation therapy (SBRT), for patients with localized prostate cancer who have undergone surgery. SBRT uses precise x-rays to target the cancer, minimizing harm to healthy tissue. This trial may suit individuals who have had prostate cancer surgery and face issues like a rising PSA level (a blood test indicator for prostate cancer) or specific surgical findings. Participants might also receive hormone therapy as part of the treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in prostate cancer care.

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 stereotactic body radiation therapy is safe for treating localized prostate cancer post-surgery?

Research has shown that stereotactic body radiation therapy (SBRT) is generally safe and well-tolerated for prostate cancer patients. Studies have found that SBRT can target cancer with precise doses of radiation while causing minimal harm to nearby healthy tissue. In one study, only 2.25% of patients experienced significant side effects, indicating that most handle the treatment well.

Another study found that SBRT is a safe option for prostate cancer, even for those who have had previous prostate surgeries. However, some experienced more bladder or urinary tract side effects.

Overall, evidence suggests that SBRT is a safe treatment for prostate cancer, especially for those who have already had surgery. However, like any treatment, some side effects may occur, so discussing these with a doctor is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Stereotactic Body Radiation Therapy (SBRT) for localized prostate cancer post-surgery is unique because it delivers highly focused radiation in fewer sessions compared to traditional radiation therapies. While standard treatments often involve multiple weeks of daily radiation, SBRT can potentially achieve similar or better results with just a few sessions over two weeks. Additionally, this approach may be combined with androgen deprivation therapy (ADT), offering a comprehensive attack on cancer cells. Researchers are excited about SBRT's potential to reduce treatment time and improve patient convenience without compromising effectiveness.

What evidence suggests that stereotactic body radiation therapy is effective for localized prostate cancer post-surgery?

Studies have shown that stereotactic body radiation therapy (SBRT) effectively treats prostate cancer that hasn't spread. Research indicates that SBRT can control cancer while minimizing damage to healthy tissue. One study found that administering SBRT in doses of 35–36.25 Gy over five sessions provides excellent cancer control with few side effects for patients with low to intermediate risk. In this trial, patients will undergo SBRT, and some may also receive hormone therapy. Studies confirm that hormone therapy can effectively manage prostate cancer after surgery. Patients often experience good long-term results with this treatment. ^{2 3 6 7 8}

Who Is on the Research Team?

Amar Kishan

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

Men with localized prostate cancer treated by surgery can join this trial. They must have a history of adenocarcinoma, no distant metastases, and not received prior pelvic radiotherapy or certain other prostate treatments. A Karnofsky score of 70+ (able to care for themselves) and rising PSA levels post-surgery are required.

Inclusion Criteria

I've had a CT or MRI of my pelvis within the last 4 months.

My prostate cancer surgery showed high-risk features or my PSA levels are rising.

I've had a bone scan within the last 4 months to check for cancer spread.

Exclusion Criteria

My prostate cancer is of the neuroendocrine or small cell type.

I have had cryosurgery, HIFU, or brachytherapy for prostate cancer.

I have had radiation therapy to my pelvic area before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo stereotactic body radiation therapy (SBRT) every other day for 14 days. They may also receive androgen deprivation therapy (ADT) for 6 months at the discretion of the treating physician.

2 weeks for SBRT, 6 months for ADT

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 1 month, every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiation Therapy

Trial Overview The trial is testing stereotactic body radiation therapy (SBRT), which targets the tumor with high-precision x-rays over several days, potentially sparing healthy tissue. It's for patients whose cancer hasn't spread and includes antiandrogen therapy and quality-of-life assessments.

How Is the Trial Designed?

Group I: Treatment (SBRT, ADT) Experimental Treatment 3 Interventions

Patients undergo SBRT QOD for 14 days. Patients may also receive ADT comprised of a luteinizing hormone-releasing hormone agonist or a gonadotropin-releasing hormone antagonist, and an oral anti-androgen for 6 months at the discretion of the treating physician.

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?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Viewray Inc.

Industry Sponsor

Trials

13

Recruited

1,100+

Published Research Related to This Trial

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]

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]

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 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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6770993/

Stereotactic Body Radiation Therapy for Localized Prostate ... Patient-reported outcomes after monitoring, surgery, or radiotherapy for prostate cancer. N Engl J Med 2016;375:1425–1437. [DOI] [PMC free article] [PubMed] ...

2. 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405630823001349

Stereotactic body radiation therapy for prostate cancer after ... Here we present an overview of the available data on urinary morbidity for prostate cancer patients treated with SBRT after prior surgical treatments for benign ...

4. practicalradonc.org practicalradonc.org/article/S1879-8500(23)00237-0/fulltext

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 ...

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

and intermediate-risk prostate cancer: clinical outcomes ... 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 with low– ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6043737/

Stereotactic ablative body radiotherapy in patients with ... SABR is a novel, non-invasive, high-precision EBRT technique that allows safe delivery of biologic doses similar to brachytherapy with similar or lower side ...

7. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2403365

Phase 3 Trial of Stereotactic Body Radiotherapy in ... Five-fraction SBRT was noninferior to control radiotherapy with respect to biochemical or clinical failure and may be an efficacious treatment option.

8. 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 ...