NCT05715502 Focal Salvage Brachytherapy Study (FocaSaBra)
| NCT ID | NCT05715502 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Greater Poland Cancer Centre |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-05-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2022-05-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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, stereotaxic 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 * 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 Exclusion Criteria: * 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
Contact & Investigator
Wojciech Burchardt, PhD, MD
PRINCIPAL INVESTIGATOR
Greater Poland Cancer Centre / Brachytherapy Department
Frequently Asked Questions
Who can join the NCT05715502 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05715502 currently recruiting?
Yes, NCT05715502 is actively recruiting participants. Contact the research team at wojciech.burchardt@wco.pl for enrollment information.
Where is the NCT05715502 trial being conducted?
This trial is being conducted at Poznan, Poland.
Who is sponsoring the NCT05715502 clinical trial?
NCT05715502 is sponsored by The Greater Poland Cancer Centre. The principal investigator is Wojciech Burchardt, PhD, MD at Greater Poland Cancer Centre / Brachytherapy Department. The trial plans to enroll 100 participants.
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