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Recruiting

NCT Number: NCT04231006

Salvage HDR for Locally Recurrent Prostate Cancer

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

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oncology

Aarhus, Region Midt, 8200, Denmark

Location status: Recruiting

Location contact

Simon Buus

CONTACT

[email protected]

40465291

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Time to castration-resistant prostate cancer

    Time frame: 10 years

    The time from intervention until the prostate cancer becomes castration resistant

Secondary outcomes

  1. Erectile dysfunction

    Time frame: 5 years

    Erectile dysfunction as reported by patients in CTCAE PRO

  2. Urinary symptoms

    Time frame: 5 years

    Urinary symptoms as reported by patients in CTCAE PRO

  3. Bowel symptoms

    Time frame: 5 years

    Bowel symptoms as reported by patients in CTCAE PRO

Study contacts

Contact information is provided by the study sponsor or research team.

Simon Buus, MD

CONTACT

[email protected]

+4540465291

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

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

Acronym: PROSALBRA

Important dates

Study start
2021
Primary completion
2025
Study completion
2035
First posted
Jan 18, 2020
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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