SBRT vs. Conventional Radiation for Prostate Cancer

(SHARP Trial)

Overseen By Gerard Morton, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Dr. Gerard Morton

Disqualifiers: Metastasis, Chemotherapy, Bowel disease, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of radiation treatments for prostate cancer to determine which is more effective. Participants will randomly receive either stereotactic body radiotherapy, a precise treatment in fewer sessions, or conventional radiation, also known as conventionally fractionated radiation, involving more sessions. The goal is to identify which approach better targets the prostate and nearby areas. Men with a confirmed diagnosis of prostate cancer who haven't undergone previous radiation or certain prostate surgeries may qualify for this trial. As an unphased trial, it offers participants the chance to contribute to important research that could enhance future prostate cancer treatments.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Stereotactic Body Radiotherapy (SBRT) is generally well-tolerated by prostate cancer patients. Studies have found that patients receiving SBRT, which delivers high doses of radiation over just a few sessions, often experience fewer side effects compared to traditional treatments.

For example, one study found that long-term cancer outcomes were similar for patients who underwent SBRT, with no significant increase in serious side effects. Another study confirmed that SBRT is safe for patients with low-risk prostate cancer, demonstrating positive long-term results.

While some risk of side effects exists with SBRT, such as tiredness or urinary issues, these are usually mild and temporary. Overall, current research supports SBRT as a safe option for treating prostate cancer, with manageable side effects for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about stereotactic body radiotherapy (SBRT) for prostate cancer because it delivers a high dose of radiation in just five sessions, compared to the 15 to 23 sessions required for conventional fractionated radiation. This means patients can complete their treatment in a shorter amount of time, which is more convenient and can improve the overall quality of life. Additionally, SBRT's precision in targeting the prostate and surrounding areas helps minimize damage to nearby healthy tissues, potentially reducing side effects.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

This trial will compare Stereotactic Body Radiotherapy (SBRT) with Conventional Fractionated Radiation for treating prostate cancer. Studies have shown that SBRT effectively treats prostate cancer. Early trials with SBRT produced impressive results, with many patients not experiencing a return of cancer markers in their blood after treatment. Another study suggested that SBRT offers similar long-term cancer control compared to other radiation treatments. Additionally, using SBRT for certain types of prostate cancer significantly improved patient outcomes. These findings suggest that SBRT is a promising option for prostate cancer treatment. ^{2 3 4 6 7}

Who Is on the Research Team?

Gerard Morton, MD, FRCPC

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for adults over 18 with prostate cancer who haven't had previous treatments like pelvic radiotherapy, brachytherapy, or surgery. They should be relatively healthy and able to consent to treatment. People with metastatic disease, serious health issues that conflict with the treatment, inflammatory bowel disease, or certain connective tissue disorders can't join.

Inclusion Criteria

I have been diagnosed with prostate cancer.

Informed consent for treatment and study participation completed

I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

My scans show cancer has spread to my lymph nodes or other parts of my body.

I am scheduled for chemotherapy after my radiotherapy.

I have a connective tissue disorder that makes radiotherapy unsafe for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

HDR Brachytherapy

Participants receive high-dose rate brachytherapy as a preparatory treatment

1 week

Radiation Treatment

Participants are randomly assigned to receive either SBRT (5 treatments) or conventional fractionated radiation (3-5 weeks of daily treatment)

3-5 weeks

Follow-up

Participants are monitored for safety, effectiveness, and quality of life outcomes

7 years

What Are the Treatments Tested in This Trial?

Interventions

• Conventionally Fractionated Radiation
• Sterotactic Body Radiotherapy

Trial Overview The study compares two types of radiation therapy for prostate cancer: Stereotactic Body Radiotherapy (SBRT) versus conventional fractionated radiation after HDR brachytherapy. Patients are randomly placed into one of these two groups.

How Is the Trial Designed?

Group I: Stereotactic Body Radiotherapy Experimental Treatment 1 Intervention

* Prostate Only Radiation - 25Gy in 5 fractions to the prostate and proximal/entire seminal vesicle * Prostate + Nodal Radiation - 25Gy in 5 fractions to the prostate, seminal vesicle and regional lymph nodes

Group II: Conventional Fractionated Radiation Active Control 1 Intervention

* Prostate Only Radiation - 37.5Gy in 15 daily fractions to the prostate and proximal/entire seminal vesicle * Prostate + Nodal Radiation - 46Gy in 23 daily fractions to the prostate, seminal vesicle and regional lymph nodes

Sterotactic Body Radiotherapy is already approved in United States, European Union for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy for:

• Liver tumors
• Non-small cell lung cancer
• Oligometastases
• Pancreatic cancer
• Renal cell carcinoma
• Prostate cancer
• Spinal or vertebral body tumors

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Primary lung cancer
• Tumors that have spread to the lung, liver, adrenal gland, or spine
• Pancreatic tumors
• Bile duct tumors
• Primary and metastatic liver tumors
• Kidney tumors
• Prostate cancer
• Pelvic tumors
• Sarcomas
• Metastatic tumors throughout the body

Who Is Running the Clinical Trial?

Dr. Gerard Morton

Lead Sponsor

Trials

1

Recruited

60+

Published Research Related to This Trial

Stereotactic ablative body radiotherapy (SABR) is an advanced treatment that delivers high doses of radiation in fewer sessions while protecting surrounding healthy tissues, making it effective for small tumors in various locations, including the prostate.

SABR is becoming a standard treatment for low and intermediate-risk prostate cancer, supported by research from Sunnybrook and the US prostate SABR consortium, highlighting its efficacy in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of hypofractionated accelerated radiotherapy for prostate cancer - the sunnybrook experience. Musunuru, HB., Cheung, P., Loblaw, A.[2022]

In a study involving 51 prostate cancer patients treated with stereotactic body radiotherapy (SBRT), the treatment showed promising outcomes with manageable toxicity levels, as no patients experienced severe (grade 3+) side effects during the initial follow-up period.

The median follow-up of 14.5 months revealed a low prostate-specific antigen level of 1.3 ng/ml at 13-18 months post-treatment, indicating effective disease control in this cohort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate stereotactic body radiotherapy—first UK experience. Tree, AC., Ostler, P., Hoskin, P., et al.[2022]

Stereotactic body radiotherapy (SBRT) is shown to be safe and effective for treating node-positive prostate cancer, with a median follow-up of 30 months revealing no severe gastrointestinal toxicities and manageable genitourinary side effects.

In a study of 60 patients, SBRT resulted in a 3-year overall survival rate of 89% and a biochemical failure-free survival rate of 77%, indicating promising long-term outcomes even in patients with advanced disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. Telkhade, T., Murthy, V., Kanala, TS., et al.[2021]

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 body radiation therapy (SBRT) is a promising treatment for prostate cancer, utilizing hypofractionation regimens that take advantage of the cancer's high sensitivity to dose per fraction.

SBRT is expected to have lower toxicity rates due to its smaller treatment margins while still effectively controlling tumor growth, making it a potentially safer option compared to conventional radiation therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for prostate cancer. Ishiyama, H., Teh, BS., Lo, SS., et al.[2018]

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 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]

Stereotactic body radiotherapy (SBRT) for localized prostate cancer has seen a significant increase in use from 2004 to 2011, while traditional treatments like brachytherapy have decreased, indicating a shift in treatment preferences.

Although SBRT is associated with lower treatment costs ($27,145) compared to IMRT ($37,090) and proton beam therapy ($54,706), it also has higher rates of erectile dysfunction and urinary incontinence, suggesting a trade-off between cost and potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use, complications, and costs of stereotactic body radiotherapy for localized prostate cancer. Halpern, JA., Sedrakyan, A., Hsu, WC., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5638714/

Stereotactic radiotherapy for prostate cancer: A review and ... We conclude that initial studies examining the use of SBRT in the treatment of prostate cancer have demonstrated impressive rates of biochemical recurrence-free ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2588931125000860

Long-term Oncological Outcomes in the Phase 2 PATRIOT ... This study suggests no significant differences in long-term cancer outcomes between EOD and QW schedules for five-fraction prostate SABR.

3. redjournal.org redjournal.org/article/S0360-3016(25)00225-1/fulltext

Primary Endpoint Analysis of the TRAP Trial Median overall survival was 27.2 months (95% CI, 24.7-36.6). Four deaths occurred within 6 months of SBRT; none were related to radiation ...

4. thegreenjournal.com thegreenjournal.com/article/S0167-8140(25)04545-1/fulltext

A site-specific analysis of the prospective, phase II ... Outcomes of Observation vs Stereotactic Ablative Radiation for Oligometastatic Prostate Cancer: the ORIOLE phase 2 Randomized Clinical Trial.

5. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2763312

Outcomes of Observation vs Stereotactic Ablative ... Conclusions and Relevance Treatment with SABR for oligometastatic prostate cancer improved outcomes and was enhanced by total consolidation of ...

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

Stereotactic ablative body radiotherapy in patients with ... Sixty-three percent, 30% and 7% had low-, intermediate- or high risk disease (26). All patients had a 5 mm planning target volume (PTV) margin around the ...

7. 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 ...