What side effects are associated with this type of intervention?

The most common treatments for prostate cancer, such as SBRT and Conventionally Fractionated Boost, have several known side effects. SBRT, which involves high-dose radiation in a few sessions, can lead to urinary toxicity, bowel toxicity, and sexual dysfunction. Conventionally Fractionated Boost, which administers smaller doses over a longer period, shares similar side effects, including urinary and bowel issues, as well as potential sexual dysfunction. Both treatments aim to balance efficacy with minimizing adverse effects, but patients may experience varying degrees of these toxicities.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including radiation therapies and drugs that can be used in combination with these therapies. Stereotactic body radiation therapy (SBRT), which delivers high-dose radiation in a few sessions, and conventionally fractionated radiation therapy, which administers smaller doses over a longer period, are both established methods. Additionally, drugs like abiraterone, enzalutamide, and docetaxel have been approved for use in various stages of prostate cancer, often in combination with radiation therapy to enhance treatment efficacy. These therapies aim to improve survival rates and manage symptoms in patients with advanced prostate cancer.

What other types of research exist?

Promising novel alternatives to SBRT and conventionally fractionated boost for prostate cancer patients include: 1) Androgen Deprivation Therapy (ADT) combined with novel agents like darolutamide or abiraterone, which have shown improved outcomes in high-risk patients. 2) Radium-223 (Ra-223), an alpha particle-emitting radiopharmaceutical, which has demonstrated prolonged overall survival and decreased symptomatic skeletal events in metastatic castration-resistant prostate cancer (CRPC). 3) Bipolar Androgen Therapy (BAT), which has shown potential in restoring sensitivity to previously used therapies like enzalutamide and abiraterone in CRPC patients. These alternatives offer new avenues for treatment beyond traditional radiation therapy.

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Radiation Therapy

SBRT vs. Conventional Radiation for Prostate Cancer (SHARP Trial)

N/A

Recruiting

Led By Gerard Morton

Research Sponsored by Dr. Gerard Morton

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pathologically proven diagnosis of prostate adenocarcinoma

Age 18 or older

Must not have

Plan for adjuvant chemotherapy post-radiotherapy

Presence of connective tissue disorder seen as a contraindication to radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18mo - 2 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include skin reactions in the treated area, fatigue, urinary and bowel symptoms such as frequency or discomfort during urination and changes in bowel habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with prostate cancer.

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I am 18 years old or older.

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

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I have never had treatments like radiation or surgery on my prostate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for chemotherapy after my radiotherapy.

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

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I cannot or do not want to fill out questionnaires.

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I have inflammatory bowel disease.

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I cannot undergo surgery with general or spinal anesthesia due to health reasons.

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I do not have serious health issues that prevent me from having HDR brachytherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18mo - 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18mo - 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18mo - 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment Feasibility

Secondary study objectives

ADT Free Survival

Cancer Free Survival

Cumulative biochemical failure

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Stereotactic Body RadiotherapyExperimental Treatment1 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 RadiationActive Control1 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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for prostate cancer include Stereotactic Body Radiation Therapy (SBRT) and Conventionally Fractionated Boost. SBRT delivers high doses of radiation in a few sessions, precisely targeting the tumor and minimizing damage to surrounding tissues, which reduces overall treatment time and may improve local tumor control. Conventionally Fractionated Boost involves administering smaller doses of radiation over a longer period, allowing gradual damage to cancer cells while giving normal tissues time to repair, potentially reducing side effects. Understanding these mechanisms helps prostate cancer patients and their doctors choose the most suitable treatment plan based on their specific medical condition and lifestyle preferences.

Androgen deprivation therapy in advanced prostate cancer: is intermittent therapy the new standard of care?