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Clinical trial Recruiting at 1 site Interventional Ages 18 and up Men only

Single fraction radiation therapy for prostate cancer

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

Run by McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT04004312 · Data updated 2026-11-12

This study is testing if a single dose of a special type of radiation therapy, combined with a gel to protect nearby organs, can safely treat men with low to moderate-risk prostate cancer.

Quick facts

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment12 (estimated)
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Montreal, Quebec)
StatusRecruiting
StartedNovember 7, 2018
Main results expectedJanuary 31, 2027
Study endsDecember 20, 2027
Registry record updatedJune 25, 2025
Trial IDNCT04004312 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include men aged 18 and older with histologically proven adenocarcinoma of the prostate and specific Gleason scores and PSA levels.

Probably not a fit

Patients opting for other treatment modalities or those with prior invasive malignancies may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and efficacy of delivering a single fraction of stereotactic body radiation therapy (SBRT) to patients with low- and favorable intermediate-risk prostate cancer. Prior to treatment, a hydrogel called SpaceOAR is injected between the prostate and rectum to increase separation and minimize side effects. Patients undergo imaging studies to create a personalized treatment plan before receiving the radiation therapy. The entire process involves a pre-treatment visit, imaging, and the actual treatment session, which is designed to be efficient and minimally invasive.

Why it matters

Potential benefit: If successful, this approach could provide a more convenient and effective treatment option for prostate cancer patients, potentially reducing the number of treatment sessions required.

How similar studies have gone: Other studies have shown promise with similar SBRT approaches, but the use of hydrogel for single fraction delivery is a novel aspect of this trial.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • McGill University Health Centre-Cedars Cancer Centre
    Montreal, Quebec, Canada     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.