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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
    • Alicante
      • Benidorm, Alicante, Spain, 03501
        • Recruiting
        • Hospital HCB Benidorm
        • Contact:
        • Principal Investigator:
          • Silvia Rodríguez Villalba, MD
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • Instituto Catalán de Oncología L'Hospitalet
        • Contact:
        • Principal Investigator:
          • Andrea Slocker Escarpa, MD
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Contact:
        • Principal Investigator:
          • Ana Soledad García Blanco, MD
    • Córdoba
      • Córdoba, Córdoba, Spain, 14004
    • Guipuzcoa
      • San Sebastián, Guipuzcoa, Spain, 20014
        • Not yet recruiting
        • Instituto Oncológico de San Sebastián (Onkologikoa)
        • Contact:
        • Principal Investigator:
          • Alai Goñi Ramírez, MD
    • Madrid
      • Madrid, Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal
        • Contact:
        • Principal Investigator:
          • María Teresa Muñoz Migueláñez, MD
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Hospital Universitario de Navarra
        • Contact:
        • Principal Investigator:
          • Ignacio Visus Fernández de Manzano, MD
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Recruiting
        • Hospital Meixoeiro
        • Contact:
        • 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:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PROSCATE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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