Stereotactic Ablative Radiotherapy for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: University of Texas Southwestern Medical Center

Must be taking: Androgen deprivation therapy

Must not be taking: 2nd generation anti-androgens

Disqualifiers: Invasive malignancy, AIDS, severe comorbidity, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat high-risk prostate cancer using Stereotactic Ablative Radiotherapy (SABR). The researchers aim to determine the highest safe dose of radiation for the prostate and pelvic areas while ensuring the treatment remains practical and safe. The trial will also monitor health outcomes such as PSA levels and quality of life. Men with prostate cancer who have a Gleason score of 8 or higher, or a PSA level of 20 or more, might find this trial suitable. 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, you cannot receive other cancer treatments like chemotherapy or certain hormone therapies while participating in this study.

What prior data suggests that this technique is safe for prostate cancer treatment?

Research has shown that stereotactic ablative radiotherapy (SABR) is generally well-tolerated by patients with prostate cancer. Studies indicate that administering a total of 40 Gy in 5 sessions is feasible and poses little additional risk for high-risk cases. One study using a dose of 45 Gy in 5 sessions also supported SABR's promising safety. Although more research is needed to understand long-term effects, these findings suggest that SABR is safe and manageable for many patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Stereotactic Ablative Radiotherapy (SABR) for prostate cancer because it offers a highly precise way to deliver radiation. Unlike traditional radiation treatments that can take weeks and sometimes affect surrounding healthy tissues, SABR targets the tumor with pinpoint accuracy, usually in just a few sessions. This precision minimizes damage to nearby healthy tissue and can potentially lead to fewer side effects. Additionally, the shorter treatment duration is more convenient for patients, which could improve their quality of life during therapy.

What evidence suggests that Stereotactic Ablative Radiotherapy could be effective for prostate cancer?

Research shows that Stereotactic Ablative Radiotherapy (SABR), the treatment under study in this trial, effectively treats prostate cancer. Studies have found that administering SABR in doses similar to 40 Gy over 5 sessions is feasible and generally well-tolerated, with few additional side effects. Long-term evidence suggests that SABR provides excellent disease control, particularly for patients with low- and intermediate-risk prostate cancer. The rates of positive biopsies and biochemical failures are similar to those seen with brachytherapy, with good results reported even 2-3 years after treatment. However, some patients might experience urinary issues in the first two years following treatment. Overall, SABR shows promise for effectively managing prostate cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Raquibul Hannan, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

Men over 18 with high-risk prostate cancer (Gleason score ≥8, PSA ≥20 ng/ml, or advanced stage) who can undergo MRI and are eligible for a rectal spacer. They must agree to use contraception during treatment and be able to give informed consent. Excluded are those with prior pelvic cancer treatments, certain heart conditions, active infections, recent TURP surgery, planned antineoplastic therapies, metastases evidence after staging studies, severe co-morbidities like AIDS or significant psychiatric illness.

Inclusion Criteria

Signed study specific informed consent form

My PSA level is 20 ng/ml or higher, or I haven't started hormone therapy for prostate cancer yet.

My lymph nodes are not cancerous as confirmed by tests within the last 3 months.

Exclusion Criteria

I have not had pelvic radiotherapy, chemotherapy, or surgery for prostate cancer.

I have been cancer-free for at least 3 years, except for non-melanoma skin cancer.

I have used hormonal therapy for less than 9 months before joining this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Androgen Suppression Therapy (ADT)

Participants receive androgen suppression therapy prior to radiation

8-12 weeks

Radiation Therapy

Participants receive stereotactic ablative radiotherapy (SABR) to prostate and pelvic regions

5 fractions

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Ablative Radiotherapy (SABR)

Trial Overview The trial tests the highest safe radiation dose that can be given to the prostate and pelvis using Stereotactic Ablative Radiotherapy (SABR). It also assesses real-time planning safety with cone-beam CT scans and GPU systems for each treatment fraction. The study aims to determine if higher doses improve tumor control without compromising quality of life.

How Is the Trial Designed?

Group I: Stereotactic Ablative Radiotherapy Experimental Treatment 1 Intervention

Stereotactic Ablative Radiotherapy (SABR)

Stereotactic Ablative Radiotherapy (SABR) is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as SABR/SBRT for:

• Low-risk prostate cancer
• Intermediate-risk prostate cancer
• High-risk prostate cancer

Approved in United States as SABR/SBRT for:

• Low-risk prostate cancer
• Intermediate-risk prostate cancer
• High-risk prostate cancer
• Recurrent prostate cancer

Approved in United Kingdom as SABR/SBRT for:

• Low-risk prostate cancer
• Intermediate-risk prostate cancer
• High-risk prostate cancer

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

Published Research Related to This Trial

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]

Stereotactic ablative radiotherapy (SABR) has been shown to be feasible and well tolerated for low- and intermediate-risk prostate cancer patients, with promising results from large randomized studies comparing it to conventional treatments.

While SABR shows potential benefits and cost-effectiveness, there is currently insufficient data to recommend its use for high-risk prostate cancer patients outside of clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Body Radiotherapy for Intermediate- or High-Risk Prostate Cancer. Loblaw, A.[2021]

Stereotactic ablative body radiation (SABR) is a promising non-invasive treatment for localized prostate cancer, showing similar efficacy to brachytherapy in terms of disease control and lower side effects, making it a potentially safer option.

SABR is also more cost-effective and resource-efficient compared to traditional radiation techniques, but further well-powered studies are needed to confirm its benefits before it can be considered standard care, especially for patients with metastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy in patients with prostate cancer. Loblaw, A., Liu, S., Cheung, P.[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]

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]

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]

In a study of 152 men with intermediate risk prostate cancer, weekly stereotactic ablative radiotherapy (SABR) resulted in better short-term bowel and urinary quality of life compared to every other day treatment, but there were no significant differences in late toxicity or long-term quality of life outcomes after 62 months.

Both treatment regimens showed similar rates of biochemical failure and overall survival, indicating that while weekly SABR may reduce acute side effects, it does not compromise long-term efficacy or safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerating prostate stereotactic ablative body radiotherapy: Efficacy and toxicity of a randomized phase II study of 11 versus 29 days overall treatment time (PATRIOT). Alayed, Y., Quon, H., Ong, A., 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]

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]

Stereotactic ablative radiotherapy (SABR) has rapidly expanded in clinical use for treating various primary and metastatic tumors, demonstrating promising results in tumor control.

Despite its effectiveness, SABR can lead to serious complications, highlighting the need for strategies to reduce these risks and improve the safety of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. Lo, SS., Sahgal, A., Chang, EL., et al.[2018]

Stereotactic ablative radiation (SAbR) at a dose of 45 Gy in 5 fractions shows a promising safety profile for treating localized prostate cancer, with acute urinary and gastrointestinal toxicity rates of 20.4% and 7.3%, respectively, and low rates of late toxicity after 2 years.

The treatment demonstrated excellent efficacy, with a biochemical failure-free survival rate of 100% at 1 year and 98.7% at 2 years, indicating strong disease control outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. Chen, L., Gannavarapu, BS., Desai, NB., 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]

Citations

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

Stereotactic ablative body radiotherapy in patients with ... Efficacy for SABR appears to be similar to brachytherapy including positive biopsy rates 2–3 years post treatment, biochemical failure (BF) rates out to 10-year ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879850025001511

Clinician- and Patient-Reported Outcomes of Stereotactic ... Conclusions. SABR delivering 40 Gy in 5 fractions is feasible and well-tolerated for high-risk prostate cancer, with minimal additional toxicity ...

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 Trial participants who were randomly assigned to receive SBRT had a higher risk of developing some urinary problems over the first 2 years after ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06325046?term=John

Adaptive Radiation Therapy (ART) Stereotactic Ablative ... Shorter duration near margin-less ART may be just as effective at treating patients with localized prostate cancer but have less quality of life side effects ...

7. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.779182/full

Dose-Intensified Stereotactic Ablative Radiation for ... SAbR for PCa at 45 Gy in 5 fractions shows an encouraging safety profile. Prospective studies with longer follow-up are warranted to establish this dose ...