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New treatment option for Prostate Cancer
Official title Salvage HDR for Locally Recurrent Prostate Cancer
ClinicalTrials.gov ID: NCT04231006
What this study is testing
- What it's testing
- The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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
You likely can't join if
- 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...
- Inflammatory bowel disease
- Contraindications to 3T MRI
- eGFR \< 30 ml/min
See the full eligibility 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
- 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...
- Inflammatory bowel disease
- Contraindications to 3T MRI
- eGFR \< 30 ml/min
- ≥ Gr 3 urinary toxicity at baseline as assessed by CTCAE 4
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Region Midt, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Region Midt, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.