Salvage High Dose Rate Brachytherapy for Local Recurrence in Prostate Cancer: A Phase II Trial

Aarhus University Hospital1 site in 1 country50 target enrollmentApril 1, 2021

ConditionsProstate Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Aarhus University Hospital
Enrollment: 50
Locations: 1
Primary Endpoint: Time to castration-resistant prostate cancer
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy

Detailed Description

The aim of this study is to examine the efficacy and toxicity of focal salvage high dose rate brachytherapy (HDR BT) for patients with locally recurrent prostate cancer after definitive external beam radiotherapy. Furthermore, the investigators want to assess, whether it is feasible to perform salvage HDR BT as a focal treatment based on multiparametric (mp) pelvine MRI and PSMA PET/CT.

Registry

clinicaltrials.gov

Start Date

April 1, 2021

End Date

March 1, 2035

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Aarhus University Hospital

Responsible Party

Principal Investigator

Simon Buus

Principal investigator

Aarhus University Hospital

Eligibility Criteria

Inclusion Criteria

•Man ≥ 18 years, who had definitive EBRT or BT for prostate cancer T1-3b, N0-1, M0
•≥ 2 years since the end of primary radiotherapy
•PSA recurrence Phoenix criteria (nadir + 2)
•No evidence of regional lymph nodes or distant metastases on PSMA PET/CT
•MRI guided biopsy-proven local recurrence of adenocarcinoma in the prostate gland or seminal vesicles
•GTV identifiable on mpMRI
•No current endocrine therapy
•Plasma testosterone ≥1.75 nm/l
•PSA doubling time ≥ 6 months and ≤ 24 months
•Performance status 0-1

Exclusion Criteria

•Pubic arc interference or major calcifications within the prostate gland.
•Contraindication for spinal or general anaesthesia.
•Conditions indicating that the patient cannot go through the radiation therapy or follow-up, or a condition where the treating oncologist thinks the patient should not participate in the trial, for example due to language problems.
•Inflammatory bowel disease
•Contraindications to 3T MRI
•eGFR \< 30 ml/min
•≥ Gr 3 urinary toxicity at baseline as assessed by CTCAE 4