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New treatment option for Prostate Cancer
Official title Focal Salvage Brachytherapy Study (FocaSaBra)
ClinicalTrials.gov ID: NCT05715502
What this study is testing
- What it's testing
- The aim of this prospective phase II study is to evaluate the toxicity of salvage partial (focal) prostate brachytherapy in patients after prior radiotherapy (standard teleradiotherapy with / without brachytherapy, hypofractionated, self-reactive HDR / LDR brachytherapy) with local recurrence on the part of the prostate gland.
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
- Histopathologically confirmed by biopsy (fusion mapping biopsy preferred) recurrence of prostate cancer after prior radical radiotherapy...
- Localized tumor lesion assessed by MRI or in the case of MR contraindications with TRUS and CT
- Exclusion of distant metastases using CT, MR, or PET imaging
- PSA doubling time over six months
- PSA value \<10 ng / ml
You likely can't join if
- PSA value\> 10ng / ml
- General condition according to the WHO scale\> 2
- Dysuria on the IPSS scale\> 20 points
- PSA doubling time \<6 months
- Inability to discontinue anticoagulants.
- An active urinary tract infection.
See the full eligibility criteria
- Histopathologically confirmed by biopsy (fusion mapping biopsy preferred) recurrence of prostate cancer after prior radical radiotherapy (brachytherapy, external beam radiotherapy alone or with brachytherapy boost...
- Localized tumor lesion assessed by MRI or in the case of MR contraindications with TRUS and CT
- Exclusion of distant metastases using CT, MR, or PET imaging
- PSA doubling time over six months
- PSA value \<10 ng / ml
- No anti-androgen treatment in the year prior
- Dysuria on the IPSS (International Prostate Symptom Score) ≤ 20 points
- General condition according to the WHO scale ≤ 2
- Signing informed consent to participate in the study
- PSA value\> 10ng / ml
- General condition according to the WHO scale\> 2
- Dysuria on the IPSS scale\> 20 points
- PSA doubling time \<6 months
- Inability to discontinue anticoagulants.
- An active urinary tract infection.
- Contraindications to general anesthesia
- Active inflammatory bowel diseases.
- Second active cancer or treatment with completion less than 3 years earlier, except for low-stage skin cancer
- Estimated Survival \<5 years
The study team makes the final eligibility decision.
Where it's taking place
- Poznan, Greater Poland Voivodeship, Poland
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 Poznan, Greater Poland Voivodeship, Poland. 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.