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Clinical Trials in Poland / NCT05715502
Recruiting Not applicable

Focal Salvage Brachytherapy Study (FocaSaBra)

NCT05715502 · tracked via the Priya Life Science Poland tracker
Sponsor
The Greater Poland Cancer Centre
Phase
Not applicable
Started
2022-05-01
Last updated
2025-04-30

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

brachytherapy

brachytherapy: Radiation: focal low dose rate or high dose rate brachytherapy for the lesion with appropriate margin, defined in magnetic resonance or positron emission tomography All recruited participants will be treated with interstitial brachytherapy for local recurrence of prostate cancer. The low dose rate of brachytherapy is used with a total dose of 145 Gy in the clinical target volume for participants after hypofractionated radiotherapy, a high dose rate brachytherapy as monotherapy or boost with external beam radiotherapy The high dose rate brachytherapy with two fractions of 13 Gy in the clinical target volume with a 3 to 14 days break is used after primary low dose rate brachytherapy or external beam radiotherapy alone.

Study 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

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Assessment of the change in the urological toxicity in points with the International Prostate Symptoms Scale — change from baseline to 24 months of follow-up
    Assessment of the change in the urological toxicity in points with the International Prostate Symptoms Scale - IPSS within 0-35 points
  • Assessment of the change in the erectile function in points with the International Index of Erectile Function 5 (IIEF-5) (0-25 points) — change from baseline to 24 months of follow-up
    Assessment of the change in the erectile function in points with the International Index of Erectile Function 5 (IIEF-5): scale 0-25 points
  • Assessment of the change in the quality of life in points with EORTC C30 and PR25 protocols. (0-100 points) — change from baseline to 24 months of follow-up
    Assessment of the change in the quality of life in points with EORTC C30 and PR25 protocols, scale: 0-100 points

Trial sites (1)

FacilityCityRegionStatus
Greater Poland Cancer Centre / Brachytherapy Department Poznan Greater Poland Voivodeship Recruiting

More The Greater Poland Cancer Centre trials in Poland

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Other trials for the same condition

Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC) Active, not recruiting
Multicenter Assessment of Clinical Utility PET / MR With the Use of the Radiotracer 68Ga-PSMA-11 in Therapy Planning Personalized in Patients With Prostate Cancer Recruiting
A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC Active, not recruiting
Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies Active, not recruiting
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05715502 on ClinicalTrials.gov ↗ ← All trials in Poland