Focal Salvage Brachytherapy Study (FocaSaBra)

Trial Title: Focal Salvage Brachytherapy Study (FocaSaBra)

NCT ID: NCT05715502

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
recurrence
prostate cancer
brachytherapy
focal treatment
salvage treatment
radiotherapy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: brachytherapy
Description: 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.
Arm group label: Experimental

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.

Detailed description: Prostate cancer is the second most common cancer among men in Poland. Currently, a large number of diagnosed patients undergo radical radiotherapy. Despite the high effectiveness of treatment, some patients experience failures in the form of regional and / or distant metastases, most often in the form of isolated local recurrence. In patients with suspected local recurrence, we can decide on emergency treatment after PET, pelvic MRI with an assessment of the prostate gland, and after excluding metastases. The oncological(NCCN ) and urological (EUA) recommendations allow salvage surgical treatment, observation, palliative pharmacological castration, or treatment using salvage brachytherapy. Salvage surgical treatment is associated with a 30-65% chance of cure in the top cancer centers in the world, and the risk of significant toxicity ranges from 17 to 48%. Treatment with brachytherapy, due to the intra-tissue nature and the short therapeutic range of radiation, can deliver a high dose to the treated area despite prior radiotherapy treatment and exhaustion of tolerance doses in critical organs, e.g., rectum and/or bladder. Treatment of the entire prostate gland gives a chance of disease-free survival for five years in approximately 65% of patients, according to the prospective study RTOG 0526. However, emergency treatment in this study was associated with a 14% risk of significant post-treatment toxicity requiring medical intervention. There are some reports in the literature on brachytherapy involving cancer in the part of the prostate gland (focal brachytherapy), but they are only retrospective. They show significant treatment efficacy and lower toxicity.

Criteria for 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

Gender: Male

Gender based: Yes

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Greater Poland Cancer Centre / Brachytherapy Department

Address:
City: Poznań
Zip: 61-866
Country: Poland

Status: Recruiting

Contact:
Last name: Wojciech Burchardt, Phd, MD

Phone: +48505149659
Email: wojciech.burchardt@wco.pl

Contact backup:
Last name: Ewa Tańska, PhD, MSc.

Phone: +618850767
Email: ewa.tanska@wco.pl

Start date: May 1, 2022

Completion date: December 31, 2028

Lead sponsor:
Agency: The Greater Poland Cancer Centre
Agency class: Other

Source: The Greater Poland Cancer Centre

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05715502