Single Fractions SBRT for Prostate Cancer

October 23, 2023 updated by: Fabio Cury

Single Fractions SBRT in the Treatment of Prostate Cancer: A Phase I Study

It is a phase I study of radical hypofractionation delivering one single fraction of SBRT in patients with low- and favorable intermediate-risk prostate cancer that will undergo placement of the SpaceOAR hydrogel prior to treatment.

Our hypothesis is that treatments can be safely delivered in one single fraction using SBRT provided the separation between the prostate and rectum is increased using the hydrogel

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

There is a pre-treatment visit to the radiation oncology department. A gel is injected between the prostate and the rectum. This procedure is done with the use of a transrectal ultrasound, similarly to the prostate biopsy the patient had. A local anesthetic will be applied to numb the skin and to the underneath tissue where the injection will be performed. The procedure itself will take approximately 20 minutes and after a short observation time, the patient returns home.

The next visit (approximately after 7 days after the insertion of the gel), a CT scan and MRI-scan will be done. Prior to the scans, a urinary catheter will be inserted in the bladder through the penis, and removed once the scans are done. Using these images, the doctor and the team involved will perform an individualized planning study to establish the safest way the radiation will enter your body. When the treatment plan is ready, patient is called to receive the single treatment.

A urinary catheter again will be inserted in the bladder and the patient will be directed to the room where your treatment will be delivered. The treatment should last approximately 30 minutes. After the treatment, the urinary catheter will be removed.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre-Cedars Cancer Centre
        • Sub-Investigator:
          • Luis Souhami, MD
        • Contact:
        • Sub-Investigator:
          • Marie Duclos, MD
        • Sub-Investigator:
          • Sergio Faria, MD
        • Contact:
        • Principal Investigator:
          • Fabio Cury, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Histologically proven adenocarcinoma of the prostate. Tl-2b (AJCC 7th edition) Gleason score 6 or 7 (3+4)) or Gleason 7(4+3) and recent PSA < 10 (less than 30 days; must obtained >90 days from stopping dutasteride or >30 days from stopping finasteride)

Recent PSA under 15 ng/dL (less than 30 days; must obtained >90 days from stopping dutasteride or >30 days from stopping finasteride) OR Gleason 7(4+3) and recent PSA < 10 (less than 30 days; must obtained >90 days from stopping dutasteride or >30 days from stopping finasteride)

International Prostate Symptom Score <16 Prostate gland volume< 80cc

Zubrod Performance Status 0-1 within 60 days prior to registration

Age >: 18

Patient must be able to provide study-specific informed consent prior to study entry.

Exclusion Criteria:

Patients who opt to receive another treatment modality, such as surgery, or undergo active surveillance.

Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. All patients with in situ carcinoma are eligible for this study (for example, carcinoma in situ of the oral cavity) except patients with carcinoma of the bladder (including in situ bladder cancer or superficial bladder cancer).

Evidence of distant metastases

Regional lymph node involvement

Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy Previous hormonal therapy, such as LHRH agonists or antagonists, anti-androgens, estrogens, or surgical castration (orchiectomy)

Use of finasteride within 30 days prior to registration. PSA should not be obtained prior to 30 days after stopping finasteride.

Use of dutasteride within 90 days prior to registration. PSA should not be obtained prior to 90 days after stopping dutasteride.

Previous or concurrent cytotoxic chemotherapy for prostate cancer Severe, active co-morbidity, defined as follows:

Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

Transmural myocardial infarction within the last 6 months

Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration

Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. (Patients on Coumadin or other blood thinning agents are eligible for this study.)

Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Fraction SBRT in the treatment of prostate cancer
Prior to treatment, a hydrogel spacer will be inserted between the recutm and prostate. A urinary catheter will also be inserted in the bladder. A single dose of 19Gy will be delivered with an IMRT technique. The treatment should last approximately 30 minutes. After the treatment, the urinary catheter will be removed.
Radiation: Stereotactic Body Radiation Therapy (SBRT)
Shorter radiation therapy means that a higher dose will be offered. To limit side effects of exposure to a high dose, a medical device protecting the rectum will be used. The medical device to be used is called SpaceOAR hydrogel (device). The SpaceOAR hydrogel creates space between the rectum and the prostate, making it much less likely that the rectum is exposed to radiation. It is injected into place prior to the start of radiation treatment using a needle. Patients may be awake or asleep under local anesthesia for the procedure. SpaceOAR hydrogel is not painful, it remains stable during radiation therapy and then is gradually absorbed by the body over the course of approximately six months, once radiation therapy has been completed.
Other Names:
  • Space OAR Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Small bowel or rectal irritation,
Time Frame: 3 months
To assess acute gastro-intestinal (GI) toxicity such as abdominal cramping, diarrhea, rectal urgency, proctitis, or hematochezia;
3 months
Bladder complications
Time Frame: 3 months
Bladder complications including urinary frequency/urgency, dysuria, hematuria, urinary tract infection, and incontinence;
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess late GI and GU toxicity
Time Frame: 3 years
gastro-intestinal (GI) toxicity such as abdominal cramping, diarrhea, rectal urgency, proctitis, or hematochezia;and GU toxicity such as Bladder complications including urinary frequency/urgency, dysuria, hematuria, urinary tract infection, and incontinence;
3 years
PSA control
Time Frame: 5 years
To assess the rate of biochemical control
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fabio Cury

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Fabio Cury, MD, McGill University Health Centre- Cedars Cancer Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2018

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

December 20, 2026

Study Registration Dates

First Submitted

June 28, 2019

First Submitted That Met QC Criteria

June 28, 2019

First Posted (Actual)

July 2, 2019

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-4650

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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