What side effects are associated with this type of intervention?

Stereotactic body radiotherapy (SBRT) for prostate cancer is designed to minimize damage to surrounding healthy tissue, but it can still cause side effects such as urinary symptoms (frequency, urgency, discomfort), bowel symptoms (diarrhea, rectal bleeding), and erectile dysfunction. Other common treatments for prostate cancer, such as radical prostatectomy, can lead to urinary incontinence and sexual dysfunction. Hormone therapy may result in hot flashes, decreased libido, and bone thinning, while chemotherapy can cause fatigue, nausea, hair loss, and increased risk of infections.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that focus on localized therapy, similar to SBRT. One notable example is the use of external beam radiation therapy (EBRT), which has been a standard treatment for localized prostate cancer. Additionally, brachytherapy, which involves placing radioactive seeds directly into the prostate, has also been approved. These treatments aim to deliver high doses of radiation to the tumor while minimizing damage to surrounding healthy tissue. While SBRT is an emerging technique that offers precise targeting and potentially fewer side effects, its use in prostate cancer is still being studied in clinical trials.

What other types of research exist?

Promising novel alternatives to SBRT for prostate cancer patients include: 1) Proton Beam Therapy: Utilizes protons to deliver precise radiation doses with minimal exit dose, reducing exposure to surrounding tissues. 2) High-Dose-Rate (HDR) Brachytherapy: Involves placing radioactive sources directly within or near the tumor, allowing high radiation doses to the tumor while sparing healthy tissue. 3) Magnetic Resonance-Guided Focused Ultrasound (MRgFUS): Uses focused ultrasound waves guided by MRI to ablate cancerous tissue non-invasively. 4) Advanced Systemic Therapies: Combining androgen deprivation therapy (ADT) with novel agents like abiraterone, enzalutamide, or apalutamide, which target androgen receptors and inhibit cancer growth.

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Radiation Therapy

SBRT After Prostatectomy for Prostate Cancer (PLUTO-MPC Trial)

N/A

Waitlist Available

Led By Dr. Chia-Lin Tseng, MD, FRCPC

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

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

Must have

Histologically confirmed diagnosis of adenocarcinoma of the prostate status post radical prostatectomy

Be older than 18 years old

Must not have

Contraindications to radical pelvic radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)

Histological or radiological node +ve (N1) or distant metastases (M1)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6.5years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a precise form of treatment in prostate cancer patients who have had surgery and still show signs of cancer. The goal is to see if this method can effectively treat the cancer with fewer treatments and less impact on healthy tissue. This newer method has shown promising outcomes with minimal side effects for prostate cancer treatment.

Who is the study for?

This trial is for men with prostate cancer who've had surgery to remove the prostate but have rising PSA levels, indicating potential cancer activity. They must not have any visible remaining disease, no spread to lymph nodes or distant areas, and no previous pelvic radiation. Participants should be able to fill out health questionnaires.

What is being tested?

The study is examining the safety and effectiveness of a targeted form of radiation therapy called SBRT for prostate cancer patients after they've undergone surgery (prostatectomy). The focus is on those with localized cancer and increasing PSA levels post-surgery.

What are the potential side effects?

Potential side effects of SBRT may include urinary issues, bowel problems, fatigue, skin reactions in treated areas, erectile dysfunction, and less commonly inflammation or damage to surrounding organs like the bladder or rectum.

Eligibility Criteria

Inclusion Criteria

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

Select...

I had surgery to remove my prostate due to adenocarcinoma.

Exclusion Criteria

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

Select...

I cannot have intense pelvic radiation due to certain health conditions.

Select...

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

Select...

I have had radiation therapy to my pelvic area before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6.5years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6.5years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6.5years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Early Adverse Events/toxicities experience by Participants

Secondary study objectives

Biochemical disease-free survival

Health Utilities using EuroQol- 5 Dimension Questionnaire

Health Utilities using The Patient-Oriented Prostate Utility Scale

+2 more

Side effects data

From 2024 Phase 1 & 2 trial • 19 Patients • NCT02919618

63%

Fatigue

47%

Ventricular Tachycardia

47%

Dizziness

42%

Dyspnea

42%

Other - Chest Pain NOS

42%

Heart Failure

42%

Hypotension

32%

Nausea

32%

Dyspepsia

26%

Pericardial Effusion

26%

Vomiting

21%

Back Pain

16%

Upper Respiratory Infection

16%

Cough

16%

Dysesthesia

16%

Cardiac Arrest

11%

Abdominal Pain

11%

Hypoxia

11%

Respiratory Failure

11%

Other - Radiation Pneumonitis

11%

Pleural Effusion

11%

Other - Pneumonia

11%

Acute Kidney Injury

11%

Headache

11%

Atrial Fibrillation

11%

Hematuria

11%

Hyperhidrosis

Pneumothorax

Alanine Aminotransferase Increased

Pleuritic Pain

Multi-organ Failure

Pericarditis

Retroperitoneal Hemorrhage

Acute Coronary Syndrome

Colitis

Malaise

Other - Dysuria

Mitral Valve Disease

Presyncope

Seizure

Sinus Tachycardia

Paresthesia

Other - Influenza

Constipation

Fracture

Syncope

Ventricular Fibrillation

Blood Bilirubin Increased

Cholecystitis

Hypertension

Intraoperative Cardiac Injury

Allergic Reaction

Chest Wall Pain

Hyperglycemia

Other - Tendon Rupture

Pulmonary Edema

Testicular Pain

Agitation

Sinusitis

Other - Shoulder Pain

Stomach Pain

Other - Polydipsia

Thromboembolic Event

Urinary Tract Infection

Other - Congestive Gastropathy

Diarrhea

Palpitations

Other - Chemical Pneumonitis

Other - Nephrolithiasis

Other - Gastroenteritis

Other - Dark Stools

Cyst

Chills

Sepsis

Flushing

Alkaline Phosphatase Increased

Hematoma

Dehydration

Ear Pain

Anemia

Gastric Hemorrhage

Hepatic Failure

Other - Accident

Other - ICD Lead Fracture

Arthritis

Aspartate Aminotransferase Increased

Spacticity

Tremors

Wheezing

Acidosis

Cognitive Disturbance

Ankle Fracture

Hypersomnia

100%

80%

60%

40%

20%

Study treatment Arm

Patients Overall Who Received SBRT

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Men with prostate cancer post-prostatectomyExperimental Treatment1 Intervention

Men with localized prostate cancer who are considered candidates for post-prostatectomy radiation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

stereotactic body radiotherapy (SBRT)

2016

Completed Phase 3

~190

0 / 4Eligibility 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

Prostate cancer treatments work through various mechanisms to target and destroy cancer cells while minimizing damage to healthy tissue. Immunotherapy, such as immune checkpoint inhibitors, enhances the body's immune response against cancer cells by targeting specific pathways like PD-1. Therapeutic vaccination with sipuleucel-T involves using the patient's own immune cells, which are modified to attack prostate cancer cells. Stereotactic body radiotherapy (SBRT) delivers high doses of radiation precisely to the tumor site, reducing harm to surrounding healthy tissue. These treatments are crucial for prostate cancer patients as they offer targeted approaches that can improve outcomes and reduce side effects compared to traditional therapies.

Role of the technical aspects of hypofractionated radiation therapy treatment of prostate cancer: a review.Optimizing dose and fractionation for stereotactic body radiation therapy. Normal tissue and tumor control effects with large dose per fraction.