Salvage HDR for Locally Recurrent Prostate Cancer

Prostate Cancer Clinical Trial

— PROSALBRA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04231006
• Other study ID #: 1-10-72-218-19
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: March 1, 2035

Study information

• Verified date: July 2021
• Source: Aarhus University Hospital
• Contact: Simon Buus, MD
• Phone: +4540465291
• Email: simbuu[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 1, 2035
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• High dose rate brachytherapy
High dose rate brachytherapy will be delivered to the site of recurrence within the prostate gland based on MRI and PSMA PET/CT

Locations

Country	Name	City	State
Denmark	Department of Oncology	Aarhus	Region Midt

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to castration-resistant prostate cancer	The time from intervention until the prostate cancer becomes castration resistant	10 years
Secondary	Erectile dysfunction	Erectile dysfunction as reported by patients in CTCAE PRO	5 years
Secondary	Urinary symptoms	Urinary symptoms as reported by patients in CTCAE PRO	5 years
Secondary	Bowel symptoms	Bowel symptoms as reported by patients in CTCAE PRO	5 years