Study on Prostate Salvage Using High-dose-rate Brachytherapy (PROSCATE)

October 6, 2026 updated by: Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

Multicenter Prospective Observational Study on Prostate Salvage Using High-dose-rate Brachytherapy

A prospective, observational, multicenter study analyzing salvage treatment for prostate cancer-diagnosed via next-generation imaging (choline positron emission tomography (PET)/prostate-specific membrane antigen (PSMA) PET and magnetic resonance imaging (MRI)) and positive biopsy-using two fractions of high-dose-rate (HDR) brachytherapy.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The objectives of this prospective, multicenter study are:

Primary:

1. Biochemical relapse-free survival, defined as the time to biochemical relapse (nadir plus 2 ng/mL - Phoenix criteria).
Secondary:
1. Local relapse-free survival, defined as the time from treatment to local relapse confirmed by imaging (choline PET/MRI).
2. Analysis of acute and chronic toxicity (Common Terminology Criteria for Adverse Events [CTCAE] version 5).
3. Assessment of patient quality of life before and after treatment to analyze the impact of local re-irradiation on daily life using the following questionnaires: International Prostate Symptom Score (IPSS), Functional Assessment of Cancer Therapy-Prostate (FACT-P), and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Prostate Module (EORTC QLQ-PR25).

Primary outcome measure: Biochemical relapse-free survival, and analysis of toxicity and quality of life in patients treated with salvage brachytherapy following radical treatment.

Study population, total number of subjects, and duration: Patients who received radical-intent radiotherapy as their initial treatment (brachytherapy alone, external beam radiotherapy, or external beam radiotherapy plus a brachytherapy boost) and were diagnosed with local recurrence via next-generation imaging techniques (choline PET/PSMA PET) and prior biopsy; these patients are scheduled to undergo salvage brachytherapy as part of routine clinical practice. A calculated sample size of 63 patients will be reached over a 2-year recruitment period. Follow-up will be conducted according to standard clinical practice every 6 months for the 4-year duration of the study.

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Patricia Willisch Santamaría, MD PhD
Phone Number: 986 811 714
Email: patricia.willisch.santamaria@sergas.es

Study Contact Backup

Name: Pablo Raña Díez
Phone Number: 914009600
Email: investigacion@seor.es

Study Locations

Spain
- Alicante
  - Benidorm, Alicante, Spain, 03501
    - Recruiting
    - Hospital HCB Benidorm
    - Contact:
      
      Silvia Rodríguez Villalba, MD
      
      Phone Number: 965 85 38 50
      
      Email: srodriguez@clinicabenidorm.com
    - Principal Investigator:
      
      Silvia Rodríguez Villalba, MD
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, Spain, 08908
    - Recruiting
    - Instituto Catalán de Oncología L'Hospitalet
    - Contact:
      
      Andrea Slocker Escarpa, MD
      
      Phone Number: 932607733
      
      Email: andrea.slocker@iconcologia.net
    - Principal Investigator:
      
      Andrea Slocker Escarpa, MD
- Cantabria
  - Santander, Cantabria, Spain, 39008
    - Recruiting
    - Hospital Universitario Marqués de Valdecilla
    - Contact:
      
      Ana Soledad García Blanco, MD
      
      Phone Number: 942 20 25 20
      
      Email: anasoledad.garcia@scsalud.es
    - Principal Investigator:
      
      Ana Soledad García Blanco, MD
- Córdoba
  - Córdoba, Córdoba, Spain, 14004
    - Recruiting
    - Hospital Universitario Reina Sofía
    - Contact:
      
      Sonia García Cabezas, MD
      
      Phone Number: 957 010 000
      
      Email: sonia.garcia.cabezas.sspa@juntadeandalucia.es
    - Principal Investigator:
      
      Sonia García Cabezas, MD
- Guipuzcoa
  - San Sebastián, Guipuzcoa, Spain, 20014
    - Not yet recruiting
    - Instituto Oncológico de San Sebastián (Onkologikoa)
    - Contact:
      
      Alai Goñi Ramírez, MD
      
      Phone Number: 943 32 80 00
      
      Email: agoni@onkologikoa.org
    - Principal Investigator:
      
      Alai Goñi Ramírez, MD
- Madrid
  - Madrid, Madrid, Spain, 28034
    - Recruiting
    - Hospital Universitario Ramón y Cajal
    - Contact:
      
      María Teresa Muñoz Migueláñez, MD
      
      Phone Number: 91 336 84 34
      
      Email: mmmiguelanez@salud.madrid.org
    - Principal Investigator:
      
      María Teresa Muñoz Migueláñez, MD
- Navarre
  - Pamplona, Navarre, Spain, 31008
    - Recruiting
    - Hospital Universitario de Navarra
    - Contact:
      
      Ignacio Visus Fernández de Manzano, MD
      
      Phone Number: 848 42 21 60
      
      Email: ignacio.visus.fdezdemanzano@navarra.es
    - Principal Investigator:
      
      Ignacio Visus Fernández de Manzano, MD
- Pontevedra
  - Vigo, Pontevedra, Spain, 36312
    - Recruiting
    - Hospital Meixoeiro
    - Contact:
      
      Patricia Willisch Santamaría, MD PhD
      
      Phone Number: 986 811 714
      
      Email: patricia.willisch.santamaria@sergas.es
    - Principal Investigator:
      
      Patricia Willisch Santamaría, MD
- Valencia
  - Valencia, Valencia, Spain, 46026
    - Recruiting
    - Hospital Universitario y Politécnico La Fe
    - Contact:
      
      Francisco Javier Celada Álvarez, MD
      
      Phone Number: 961 24 40 00
      
      Email: celada_fra@gva.es
    - Principal Investigator:
      
      Francisco Javier Celada Álvarez, MD
- Vizcaya
  - Barakaldo, Vizcaya, Spain, 48903
    - Not yet recruiting
    - Hospital Universitario de Cruces
    - Contact:
      
      David Büchser García, MD
      
      Phone Number: 946 006 591
      
      Email: david.buechsergarcia@osakidetza.eus
    - Principal Investigator:
      
      David Büchser García, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients treated with radical-intent radiotherapy as their primary treatment (brachytherapy alone, external beam radiotherapy, or external beam radiotherapy plus a brachytherapy boost) who have been diagnosed with local recurrence via next-generation imaging techniques (Choline PET or PSMA PET) and prior biopsy, and who are to undergo salvage brachytherapy as part of routine clinical practice.

Description

Inclusion Criteria:

Age over 18 years.
Patients diagnosed with local recurrence confirmed by next-generation imaging and a positive biopsy.
Hormone-sensitive patient.
Patients whose initial treatment consisted of brachytherapy alone, external beam radiotherapy, or external beam radiotherapy with a prostate brachytherapy boost.

Exclusion Criteria:

Metastatic disease.
Castration-resistant prostate cancer, defined according to EAU (European Association of Urology) guidelines: A patient who progresses despite maintaining testosterone levels within the castration range (testosterone <50 ng/dL or <1.7 nmol/L) and presents with at least one of the following factors: Three consecutive rises in PSA (Prostate-Specific Antigen) levels, measured one week apart, representing two increases of 50% above the nadir, with a PSA level >2; PSA progression despite successive hormonal manipulations; Progression of bone lesions: progression or appearance of two or more bone lesions, or soft-tissue progression according to Response Evaluation Criteria in Solid Tumors (RECIST criteria).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: COHORT
Time Perspectives: PROSPECTIVE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical relapse-free survival Time Frame: From the date of salvage brachytherapy to 48 months after treatment	Time from salvage brachytherapy to biochemical recurrence of prostate cancer, defined according to the Phoenix definition as a rise in prostate-specific antigen (PSA) of ≥2 ng/mL above the post-treatment PSA nadir. Patients without biochemical recurrence will be censored at the date of their last available PSA assessment or at the end of the study follow-up. PSA measurements will be obtained at 1 month after treatment and subsequently every 6 months through 48 months.	From the date of salvage brachytherapy to 48 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Characteristics Time Frame: Baseline, Day 0	Initial disease characteristics: Initial PSA, Gleason/Grade Group, Stage Biopsy characteristics, Initial imaging, Initial treatment. Disease characteristics at recurrence: PSA at recurrence, prostate-specific antigen doubling time (PSADT), Location of recurrence, Recurrence biopsy, Urinary symptoms, Imaging findings	Baseline, Day 0
Incidence of Late and Chronic Treatment-Related Toxicity Time Frame: From 1 month after salvage brachytherapy to 48 months after treatment	Incidence and severity of late and chronic treatment-related toxicity following salvage brachytherapy, assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Toxicities will include genitourinary and gastrointestinal toxicities and other treatment-related adverse events identified during follow-up.	From 1 month after salvage brachytherapy to 48 months after treatment
Local Relapse-Free Survival Time Frame: From the date of salvage brachytherapy to 48 months after treatment	Time from salvage brachytherapy to radiologically confirmed local recurrence of prostate cancer. Local recurrence will be assessed using imaging techniques, including prostate MRI, choline PET, and/or PSMA PET, according to routine clinical practice. Patients without radiologically confirmed local recurrence will be censored at the date of their last available imaging assessment or at the end of the study follow-up.	From the date of salvage brachytherapy to 48 months after treatment
Incidence of Acute Treatment-Related Toxicity Time Frame: From the date of salvage brachytherapy to 1 month after treatment	Incidence and severity of acute treatment-related toxicity following salvage brachytherapy, assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Acute toxicity will include genitourinary and gastrointestinal toxicities and other treatment-related adverse events occurring during the acute post-treatment period.	From the date of salvage brachytherapy to 1 month after treatment
Change in International Prostate Symptom Score (IPSS) From Baseline Time Frame: Baseline and every 6 months after salvage brachytherapy through 48 months	Change in urinary symptoms assessed using the International Prostate Symptom Score (IPSS). The IPSS will be assessed before salvage brachytherapy and during follow-up every 6 months. The change from baseline will be evaluated over the study follow-up period.	Baseline and every 6 months after salvage brachytherapy through 48 months
Change in Prostate Cancer-Specific Quality of Life (FACT-P) From Baseline Time Frame: Baseline and every 6 months after salvage brachytherapy through 48 months	Change in health-related quality of life assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. The FACT-P is a 39-item questionnaire assessing health-related quality of life in patients with prostate cancer. The total score ranges from 0 to 156, with higher scores indicating better health-related quality of life. The questionnaire will be administered before salvage brachytherapy and during follow-up every 6 months. Changes from baseline in the FACT-P total score will be evaluated throughout the study follow-up period.	Baseline and every 6 months after salvage brachytherapy through 48 months
Change in Prostate Cancer-Specific Quality of Life (EORTC QLQ-PR25) From Baseline Time Frame: Baseline and every 6 months after salvage brachytherapy through 48 months	Change in prostate cancer-specific health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Prostate Module (EORTC QLQ-PR25). The EORTC QLQ-PR25 consists of 25 items scored on a 0 to 100 scale after linear transformation. Higher scores indicate greater symptom burden for symptom scales and higher levels of functioning or activity for the sexual activity/function scales. The questionnaire will be administered before salvage brachytherapy and during follow-up every 6 months. Changes from baseline in the EORTC QLQ-PR25 scores will be evaluated throughout the study follow-up period..	Baseline and every 6 months after salvage brachytherapy through 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

Investigators

Study Director: Patricia Willisch Santamaría, MD PhD, Galicia Sur Health Research Institute
Study Chair: Pablo Raña Díez, Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2026

Primary Completion (Estimated)

January 31, 2032

Study Completion (Estimated)

April 30, 2032

Study Registration Dates

First Submitted

September 30, 2026

First Submitted That Met QC Criteria