Salvage HDR for Locally Recurrent Prostate Cancer | NCT04231006

Studies
Salvage HDR for Locally Recurrent Prostate Cancer

NCT04231006

Sponsor

Aarhus University Hospital

Status

Recruiting

Last Update Posted

Jul 21, 2021Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

High dose rate brachytherapy

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2021Actual

Primary Completion Date

Mar 1, 2025Estimated

Completion Date

Mar 1, 2035Estimated

First Submitted Date

Jan 7, 2020

First Submission Date that Met QC Criteria

Jan 13, 2020

First Posted Date

Jan 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2021

Last Update Posted Date

Jul 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single arm	Experimental	Single arm	Radiation: High dose rate brachytherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High dose rate brachytherapy	Radiation	High dose rate brachytherapy will be delivered to the site of recurrence within the prostate gland based on MRI and PSMA PET/CT	Single arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to castration-resistant prostate cancer	The time from intervention until the prostate cancer becomes castration resistant	10 years

Secondary Outcomes

Measure	Description	Time Frame
Erectile dysfunction	Erectile dysfunction as reported by patients in CTCAE PRO	5 years
Urinary symptoms	Urinary symptoms as reported by patients in CTCAE PRO

Other Outcomes

Not provided

Eligibility Module

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
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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Simon Buus, MD	Contact	+4540465291		simbuu@rm.dk

Facility	Status	City	State	ZIP	Country	Contacts
Department of Oncology	Recruiting	Aarhus	Region Midt	8200	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms