Single fraction radiation therapy for prostate cancer
Single Fractions SBRT in the Treatment of Prostate Cancer: A Phase I Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT04004312 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older with histologically proven adenocarcinoma of the prostate and specific Gleason scores and PSA levels.
Not a fit: Patients opting for other treatment modalities or those with prior invasive malignancies may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Montreal, Quebec
- McGill University Health Centre-Cedars Cancer Centre — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Fabio Cury, MD — McGill University Health Centre- Cedars Cancer Centre
- Study coordinator: Marianna Perna
- Email: marianna.perna@muhc.mcgill.ca
- Phone: 514-934-1934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.