None listed
Conditions
Brief summary
This study aims to evaluate the toxicity and quality of life (QOL) outcomes associated with 5-fraction stereotactic ablative radiotherapy (SABR) for high risk and/or node positive prostate cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have high risk and/or node positive prostate cancer. Study details: Traditional radiotherapy for high risk and/or node positive prostate cancer typically involves four to eight weeks of daily treatment, with androgen deprivation therapy, 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 for intermediate risk prostate cancer. 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 for high risk and/or node positive prostate cancer. This is an appealing option from a patient convenience and healthcare cost-saving point of view. In this Australian phase 2 trial of 5-treatment prostate and pelvic SABR, we aim to evaluate the efficacy, toxicity and quality of life outcomes of this treatment.
Interventions
Patients will receive stereotactic ablative radiotherapy (SABR) to the prostate and pelvic lymph nodes, delivered in five fractions, one fraction per week.
The study will recruit two cohorts of patients – Cohort A: high-risk node negative prostate cancer; Cohort B: node-positive non-metastatic prostate cancer. This study will aim to deliver SABR over 5 fractions: 36.25 Gy to the prostate, 25 Gy to the uninvolved seminal vesicle, 25 Gy to the elective pelvic nodes, (and 35 Gy to the involved no
Patients will receive stereotactic ablative radiotherapy (SABR) to the prostate and pelvic lymph nodes, delivered in five fractions, one fraction per week. The study will recruit two cohorts of patients – Cohort A: high-risk node negative prostate cancer; Cohort B: node-positive non-metastatic prostate cancer. This study will aim to deliver SABR over 5 fractions: 36.25 Gy to the prostate, 25 Gy to the uninvolved seminal vesicle, 25 Gy to the elective pelvic nodes, (and 35 Gy to the involved node in Cohort B), one fraction per week. SABR will be prescribed by the treating radiation oncologist. Adherence to the intervention will be assessed by review of medical records.
Sponsors
Alfred Health
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Either - Cohort A: Histologically confirmed high risk prostate cancer (at least one high risk feature i.e. International Society of Urological Pathology (ISUP) Grade group >/= 4, serum PSA >/= 20ng/mL, clinical stage T3/4. - Cohort B: PSMA PET confirmed pelvic node positive prostate cancer, up to 5 involved nodes. 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) questionnaire
Exclusion criteria
- Metastatic disease outside of pelvis (i.e. M1a, M1b, or M1c) on PSMA PET staging - Contraindications to Magnetic Resonance Imaging (MRI) - Prior pelvic radiotherapy or prior radical prostatectomy - Prior pharmacologic androgen ablation for prostate cancer - Prostate volume >100cc - >5 pelvic lymph nodal involvement on PSMA-PET - Severe obstructive lower urinary tract symptoms (International Prostate Symptom Score >/=20) - Bleeding diathesis or use of anti-coagulation that is unsafe to discontinue for fiducial marker insertion. - Comorbidities which predispose to significant radiation therapy toxicities (e.g., inflammatory bowel disease) - Hip replacement or other pelvic metalwork that may cause artefact on diffusion-weighted magnetic resonance imaging.
Outcome results
None listed