NCT04231006Recruiting
Salvage HDR for Locally Recurrent Prostate Cancer
Salvage High Dose Rate Brachytherapy for Local Recurrence in Prostate Cancer: A Phase II Trial
Source: ClinicalTrials.gov · Last updated 21 Jul 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 7 Jan 2020
- Start date
- 1 Apr 2021
- Primary completion date
- 1 Mar 2025
- Lead sponsor
- Aarhus University Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT04231006
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Apr 2021 to the primary completion date, 1 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- eGFR \< 30 ml/min
Other
- Pubic arc interference or major calcifications within the prostate gland.
- Contraindication for spinal or general anaesthesia.
- Contraindications to 3T MRI
- ≥ Gr 3 urinary toxicity at baseline as assessed by CTCAE 4
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Oncology Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.