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Focal Salvage Brachytherapy Study (FocaSaBra) (FocaSaBra)

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
brachytherapy
Sponsored by
The Greater Poland Cancer Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring recurrence, prostate cancer, brachytherapy, focal treatment, salvage treatment, radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Greater Poland Cancer Centre / Brachytherapy DepartmentRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Experimental: All recruited participants will be treated with salvage partial (focal) prostate brachytherapy for the lesion of recurrent prostate cancer with appropriate margin.

Outcomes

Primary Outcome Measures

Assessment of the change in the urological toxicity in points with the International Prostate Symptoms Scale (IPSS (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)
Assessment of the change in the quality of life in points with EORTC C30 and PR25 protocols. (0-100 points)

Secondary Outcome Measures

Assessment of the adverse events in the percentage of grades with the CTCAE v4.0 scale (0-5 grades)

Full Information

First Posted
December 13, 2022
Last Updated
January 27, 2023
Sponsor
The Greater Poland Cancer Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05715502
Brief Title
Focal Salvage Brachytherapy Study (FocaSaBra)
Acronym
FocaSaBra
Official Title
Assessment of the Toxicity of Focal Salvage Brachytherapy of Recurrent Prostate Cancer After Prior Radiotherapy - the Prospective Focal Salvage Brachytherapy Study (FocaSaBra)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Greater Poland Cancer Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
recurrence, prostate cancer, brachytherapy, focal treatment, salvage treatment, radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Experimental: All recruited participants will be treated with salvage partial (focal) prostate brachytherapy for the lesion of recurrent prostate cancer with appropriate margin.
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Intervention 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.
Primary Outcome Measure Information:
Title
Assessment of the change in the urological toxicity in points with the International Prostate Symptoms Scale (IPSS (0-35 points)
Time Frame
change from baseline to 24 months of follow-up
Title
Assessment of the change in the erectile function in points with the International Index of Erectile Function 5 (IIEF-5) (0-25 points)
Time Frame
change from baseline to 24 months of follow-up
Title
Assessment of the change in the quality of life in points with EORTC C30 and PR25 protocols. (0-100 points)
Time Frame
change from baseline to 24 months of follow-up
Secondary Outcome Measure Information:
Title
Assessment of the adverse events in the percentage of grades with the CTCAE v4.0 scale (0-5 grades)
Time Frame
24 months after treatment

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wojciech Burchardt, PhD, MD
Phone
+48505149659
Email
wojciech.burchardt@wco.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Ewa Tańska, PhD, MSc.
Phone
+618850767
Email
ewa.tanska@wco.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wojciech Burchardt, PhD, MD
Organizational Affiliation
Greater Poland Cancer Centre / Brachytherapy Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Greater Poland Cancer Centre / Brachytherapy Department
City
Poznań
State/Province
Greater Poland
ZIP/Postal Code
61-866
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wojciech Burchardt, Phd, MD
Phone
+48505149659
Email
wojciech.burchardt@wco.pl
First Name & Middle Initial & Last Name & Degree
Ewa Tańska, PhD, MSc.
Phone
+618850767
Email
ewa.tanska@wco.pl

12. IPD Sharing Statement

Citations:
PubMed Identifier
33545689
Citation
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Results Reference
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27568654
Citation
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Results Reference
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PubMed Identifier
17694553
Citation
Nguyen PL, D'Amico AV, Lee AK, Suh WW. Patient selection, cancer control, and complications after salvage local therapy for postradiation prostate-specific antigen failure: a systematic review of the literature. Cancer. 2007 Oct 1;110(7):1417-28. doi: 10.1002/cncr.22941.
Results Reference
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Citation
Crook, J. M., Rodgers, J., Pisansky, T. M., Trabulsi, E., Amin, M., Bice, W., Morton, G., Pervez, N., Vigneault, E., Catton, C. N., Michalski, J. M., Roach, M., Beyer, D. C., Rossi, P. J., Horwitz, E. M., Donavanik, V., Sandler, H. M., Siva, S., Bressel, M., … Ball, D. (2020). Salvage Low Dose Rate Prostate Brachytherapy: Clinical Outcomes of a Phase II Trial for Local Recurrence after External Beam Radiotherapy (NRG/RTOG -0526). International Journal of Radiation Oncology, Biology, Physics, 108(3), S3. https://doi.org/10.1016/J.IJROBP.2020.07.2071
Results Reference
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PubMed Identifier
30312717
Citation
Crook JM, Zhang P, Pisansky TM, Trabulsi EJ, Amin MB, Bice W, Morton G, Pervez N, Vigneault E, Catton C, Michalski J, Roach M 3rd, Beyer D, Jani A, Horwitz E, Donavanik V, Sandler H. A Prospective Phase 2 Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Cancer After External Beam Radiation Therapy (NRG Oncology/RTOG-0526). Int J Radiat Oncol Biol Phys. 2019 Feb 1;103(2):335-343. doi: 10.1016/j.ijrobp.2018.09.039. Epub 2018 Oct 9.
Results Reference
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PubMed Identifier
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Citation
Aaronson DS, Yamasaki I, Gottschalk A, Speight J, Hsu IC, Pickett B, Roach M 3rd, Shinohara K. Salvage permanent perineal radioactive-seed implantation for treating recurrence of localized prostate adenocarcinoma after external beam radiotherapy. BJU Int. 2009 Sep;104(5):600-4. doi: 10.1111/j.1464-410X.2009.08445.x. Epub 2009 Feb 23.
Results Reference
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Focal Salvage Brachytherapy Study (FocaSaBra)

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