Focal salvage brachytherapy for recurrent prostate cancer
Salvage High Dose Rate Brachytherapy for Local Recurrence in Prostate Cancer: A Phase II Trial
This study tests if a targeted radiation treatment can help men with prostate cancer that has come back after previous radiation therapy, using special imaging to guide the treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Aarhus University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Aarhus, Region Midt) |
| Trial ID | NCT04231006 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of focal salvage high dose rate brachytherapy (HDR BT) for patients with locally recurrent prostate cancer following definitive external beam radiotherapy. It aims to determine the feasibility of using multiparametric pelvic MRI and PSMA PET/CT to guide the treatment. The study will assess both the efficacy of the treatment and any associated toxicities in this patient population.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older who have experienced a local recurrence of prostate cancer after prior definitive radiotherapy and meet specific clinical criteria.
Not a fit: Patients with distant metastases, significant comorbidities, or contraindications to radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a targeted treatment option for patients with recurrent prostate cancer, potentially improving outcomes and reducing side effects.
How similar studies have performed: Other studies have shown promise with similar focal treatment approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Man ≥ 18 years, who had definitive EBRT or BT for prostate cancer T1-3b, N0-1, M0 * ≥ 2 years since the end of primary radiotherapy * PSA recurrence Phoenix criteria (nadir + 2) * No evidence of regional lymph nodes or distant metastases on PSMA PET/CT * MRI guided biopsy-proven local recurrence of adenocarcinoma in the prostate gland or seminal vesicles * GTV identifiable on mpMRI * No current endocrine therapy * Plasma testosterone ≥1.75 nm/l * PSA doubling time ≥ 6 months and ≤ 24 months * Performance status 0-1 * DAN PSS score ≤ 20 * Maximal urinary flow ≥ 10 ml/s * Life expectancy \> 5 years * PSA ≤ 10 ug/L at recurrence Exclusion Criteria: * Pubic arc interference or major calcifications within the prostate gland. * Contraindication for spinal or general anaesthesia. * Conditions indicating that the patient cannot go through the radiation therapy or follow-up, or a condition where the treating oncologist thinks the patient should not participate in the trial, for example due to language problems. * Inflammatory bowel disease * Contraindications to 3T MRI * eGFR \< 30 ml/min * ≥ Gr 3 urinary toxicity at baseline as assessed by CTCAE 4
Where this trial is running
Aarhus, Region Midt
- Department of Oncology — Aarhus, Region Midt, Denmark (Recruiting)
Study contacts
- Study coordinator: Simon Buus, MD
- Email: simbuu@rm.dk
- Phone: +4540465291
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.