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NCT04004312Recruiting

Single Fractions SBRT for Prostate Cancer

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

Source: ClinicalTrials.gov · Last updated 25 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
12 (estimated)
First submitted
28 Jun 2019
Start date
7 Nov 2018
Primary completion date
31 Jan 2027
Lead sponsor
Fabio Cury
NCT number
NCT04004312

What you commit to

  • Study type: Interventional
  • Planned participants: 12
  • From 7 Nov 2018 to the primary completion date, 31 Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).
  • 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:

Other illness

  • 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
  • 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.

Lab values

  • 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.)

Other

  • Evidence of distant metastases
  • Regional lymph node involvement

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
McGill University Health Centre-Cedars Cancer Centre
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.