Single Fractions SBRT for Prostate Cancer

NCT04004312 | Recruiting DMC

• 1 other identifier: 2019-4650
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Keywords

single fraction; SBRT; Space OAR Gel

Outcome Measures

Primary Outcomes (2)

• Small bowel or rectal irritation,

  To assess acute gastro-intestinal (GI) toxicity such as abdominal cramping, diarrhea, rectal urgency, proctitis, or hematochezia;

  3 months

• Bladder complications

  Bladder complications including urinary frequency/urgency, dysuria, hematuria, urinary tract infection, and incontinence;

  3 months

Secondary Outcomes (2)

• To assess late GI and GU toxicity

  3 years

• PSA control

  5 years

Study Arms (1)

Single Fraction SBRT in the treatment of prostate cancer

EXPERIMENTAL

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)

Interventions

Stereotactic Body Radiation Therapy (SBRT) RADIATION

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.

Also known as: Space OAR Gel

Single Fraction SBRT in the treatment of prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fabio Cury: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

McGill University Health Centre-Cedars Cancer Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Related Publications (35)

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MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Fabio Cury, MD

  McGill University Health Centre- Cedars Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianna Perna

CONTACT

514-934-1934; marianna.perna@muhc.mcgill.ca

Tatiana Carvalho

CONTACT

514-934-1934; tatiana.carvalho@muhc.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 2, 2019
• Study Start: November 7, 2018
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

CA (1)