None listed
Conditions
Brief summary
This study aims to evaluate the toxicity and quality of life outcomes (QOL) associated with 2-fraction stereotactic ablative radiotherapy (SABR) for localized prostate cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have intermediate risk localised prostate cancer. Study details: Traditional radiotherapy for prostate cancer typically involves four to eight weeks of daily treatment, Recent studies have shown that using fewer but larger doses of radiation, i.e. 5-treatment SABR, is just as effective and safe, and this has now become one of the standard radiotherapy schedules. The question then is whether we can further reduce the number of treatments for prostate SABR while maintaining the cancer control rate and minimizing side effects. This is an appealing option from a patient convenience and healthcare cost-saving point of view. In this Australian phase 2 trial of 2-treatment prostate SABR, we aim to evaluate the efficacy, toxicity and quality of life outcomes of 2-treatment prostate SABR.
Interventions
Patients will receive Stereotactic Ablative Radiotherapy (SABR) to the prostate, 26Gy in 2 fractions, one week apart. Treatment will be prescribed by radiation oncologist.
Adherence to the intervention will be assessed by review of medical records.
Sponsors
Alfred Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Histologically confirmed intermediate risk prostate cancer (at least one intermediate risk features i.e. International Society of Urological Pathology (ISUP) Grade Group 2-3, serum PSA 10-20 ng/mL, or clinical T2b/c; and no high risk features i.e., ISUP Grade Group >/= 4, serum PSA >/= 20 ng/mL, clinical T3/4) - Eastern Cooperative Oncology Group (ECOG) 0-2 - Capacity to consent to treatment and comply with follow-up schedule and completion of toxicity and quality of life (QOL) questionnaires
Exclusion criteria
- Any National Comprehensive Cancer Network (NCCN) high risk features (i.e., ISUP Grade Group >/=4, serum PSA >/=20 ng/mL, clinical T3/4), or evidence of nodal or distant metastatic disease on staging prostate-specific membrane antigen (PSMA) positron emission tomography (PET) - Contraindications to magnetic resonance imaging (MRI) - Prior pelvic radiotherapy - Prostate volume >100cc - Severe obstructive lower urinary tract symptoms (IPSS >/=20) - Bleeding diathesis or use of anti-coagulation that is unsafe to discontinue for fiducial marker and rectal-spacing gel insertion - Comorbidities which predispose to significant radiation therapy toxicities (e.g., inflammatory bowel disease) - Unilateral or bilateral hip replacement or other pelvic metalwork that may cause artefact on diffusion-weighted magnetic resonance imaging.
Outcome results
None listed