Salvage HDR for Locally Recurrent Prostate Cancer
Salvage High Dose Rate Brachytherapy for Local Recurrence in Prostate Cancer: A Phase II Trial
About This Trial
- This clinical trial is testing a targeted internal radiation treatment for men whose prostate cancer has returned only inside the prostate after prior radiation therapy.
- It is meant for patients who completed their original radiation at least two years ago and whose cancer has not spread to other parts of the body.
- During the treatment, doctors place temporary radiation sources directly into the area where the cancer returned, aiming to destroy the tumor while protecting nearby healthy tissue.
- Before joining, patients must have imaging and a biopsy confirming the exact location of the cancer, have fairly good urinary health, and be well enough to safely undergo anesthesia for the procedure.
More Information
- The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This clinical trial is testing a targeted internal radiation treatment for men whose prostate cancer has returned only inside the prostate after prior radiation therapy.
Study Details
- Start Date: April 1, 2021
- Lead Sponsor: Aarhus University Hospital
Full Eligibility 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
Treatments
- Radiation: High dose rate brachytherapy