SBRT vs. Conventional Radiation for Prostate Cancer

(SHARP Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Gerard Morton, MD, FRCPC

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dr. Gerard Morton

Disqualifiers: Metastasis, Chemotherapy, Bowel disease, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial compares two types of radiation treatments for men with prostate cancer. It aims to see if a shorter, intense treatment is as effective as a longer one. Both treatments use high doses of radiation to kill cancer cells. The modern technique delivers high doses in fewer sessions, showing promise in terms of safety, effectiveness, and cost.

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 data supports the effectiveness of this treatment for prostate cancer?

Research shows that Stereotactic Body Radiation Therapy (SBRT) is promising for prostate cancer because it uses fewer high-dose treatments, which may be more effective and have lower side effects compared to traditional methods. Studies indicate that SBRT can improve patient outcomes by precisely targeting the cancer with less damage to surrounding tissues. ^{1 2 3 4 5}

Is SBRT safe for treating prostate cancer?

Research shows that SBRT (Stereotactic Body Radiation Therapy) is generally safe for treating localized prostate cancer, with studies indicating its safety and effectiveness in delivering high doses of radiation in fewer sessions compared to conventional methods. ^{3 4 5 6 7}

How is SBRT different from conventional radiation treatment for prostate cancer?

SBRT (Stereotactic Body Radiotherapy) for prostate cancer uses fewer, higher doses of radiation, which may be more effective due to the cancer's sensitivity to dose per fraction. This approach can lead to better outcomes with potentially lower side effects compared to traditional radiation therapy. ^{1 2 3 4 8}

Research Team

Gerard Morton, MD, FRCPC

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

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 am 18 years old or older.

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.

Trial Timeline

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

Treatment Details

Interventions

• Conventionally Fractionated Radiation (Radiation Therapy)
• Sterotactic Body Radiotherapy (Radiation Therapy)

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.

Participant Groups

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

Who Is Running the Clinical Trial?

Dr. Gerard Morton

Lead Sponsor

Trials

1

Recruited

60+

Findings from Research

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 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) 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 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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for prostate cancer. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Prostate stereotactic body radiotherapy—first UK experience. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer: the Georgetown University experience. [2022]

4. Netherlands 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. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Propensity score matched comparison of SBRT versus IMRT for the treatment of localized prostate cancer. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Evolution of hypofractionated accelerated radiotherapy for prostate cancer - the sunnybrook experience. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. [2021]

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

Use, complications, and costs of stereotactic body radiotherapy for localized prostate cancer. [2022]