Salvage HDR for Locally Recurrent Prostate Cancer

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: High dose rate brachytherapy

• Registration Number: NCT04231006
• Lead Sponsor: Aarhus University Hospital

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.

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-18
• Study Start: 2021-04-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21
• Primary Completion: 2025-03-01
• Study Completion: 2035-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 50

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
• DAN PSS score ≤ 20
• Maximal urinary flow ≥ 10 ml/s
• Life expectancy > 5 years
• PSA ≤ 10 ug/L at recurrence

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	High dose rate brachytherapy	Single arm

Primary Outcome Measures

Name	Time	Method
Time to castration-resistant prostate cancer	10 years	The time from intervention until the prostate cancer becomes castration resistant

Secondary Outcome Measures

Name	Time	Method
Erectile dysfunction	5 years	Erectile dysfunction as reported by patients in CTCAE PRO
Urinary symptoms	5 years	Urinary symptoms as reported by patients in CTCAE PRO
Bowel symptoms	5 years	Bowel symptoms as reported by patients in CTCAE PRO

Trial Locations

Locations (1)

Department of Oncology; 🇩🇰 Aarhus, Region Midt, Denmark