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Prostate CancerPROSCATENCT07860528

Study on Prostate Salvage Using High-dose-rate Brachytherapy

An observational study of Prostate Cancer and Locally Recurrent Cancer, run by Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic at 10 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
63 participants
Where
10 sitesSpain
Study dates
11 Mar 2026to 30 Apr 2032
How long will I take part?
4 Years
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Patricia Willisch Santamaría, MD PhD contact

986 811 714

patricia.willisch.santamaria@sergas.es

Pablo Raña Díez contact

914009600

investigacion@seor.es

10 sites in 1 country

Spain10 sites, 10 recruiting

  • Hospital Universitario de Cruces

    Barakaldo, Vizcaya, 48903

    David Büchser García, MD, 946 006 591, david.buechsergarcia@osakidetza.eus

    David Büchser García, MD

    Not yet recruiting

  • Hospital HCB Benidorm

    Benidorm, Alicante, 03501

    Silvia Rodríguez Villalba, MD, 965 85 38 50, srodriguez@clinicabenidorm.com

    Silvia Rodríguez Villalba, MD

    Recruiting

  • Hospital Universitario Reina Sofía

    Córdoba, Córdoba, 14004

    Sonia García Cabezas, MD, 957 010 000, sonia.garcia.cabezas.sspa@juntadeandalucia.es

    Sonia García Cabezas, MD

    Recruiting

  • Instituto Catalán de Oncología L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

    Andrea Slocker Escarpa, MD, 932607733, andrea.slocker@iconcologia.net

    Andrea Slocker Escarpa, MD

    Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, 28034

    María Teresa Muñoz Migueláñez, MD, 91 336 84 34, mmmiguelanez@salud.madrid.org

    María Teresa Muñoz Migueláñez, MD

    Recruiting

  • Hospital Universitario de Navarra

    Pamplona, Navarre, 31008

    Ignacio Visus Fernández de Manzano, MD, 848 42 21 60, ignacio.visus.fdezdemanzano@navarra.es

    Ignacio Visus Fernández de Manzano, MD

    Recruiting

  • Instituto Oncológico de San Sebastián (Onkologikoa)

    San Sebastián, Guipuzcoa, 20014

    Alai Goñi Ramírez, MD, 943 32 80 00, agoni@onkologikoa.org

    Alai Goñi Ramírez, MD

    Not yet recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

    Ana Soledad García Blanco, MD, 942 20 25 20, anasoledad.garcia@scsalud.es

    Ana Soledad García Blanco, MD

    Recruiting

  • Hospital Universitario y Politécnico La Fe

    Valencia, Valencia, 46026

    Francisco Javier Celada Álvarez, MD, 961 24 40 00, celada_fra@gva.es

    Francisco Javier Celada Álvarez, MD

    Recruiting

  • Hospital Meixoeiro

    Vigo, Pontevedra, 36312

    Patricia Willisch Santamaría, MD PhD, 986 811 714, patricia.willisch.santamaria@sergas.es

    Patricia Willisch Santamaría, MD

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Keywords
Prostate cancer, Salvage brachytherapy, Local recurrence, Reirradiation, Biochemical relapse-free survival, Local recurrence-free survival, Biochemical recurrence, Acute and chronic toxicity, Quality of life, Choline PET; PSMA PET, MRI, Prostate biopsy, External beam radiotherapy, Brachytherapy boost, Salvage treatment
Medical subject headings
Prostatic Neoplasms, Radiation Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemical relapse-free survival

    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.

    Measured: From the date of salvage brachytherapy to 48 months after treatment

Secondary outcomes (7)

  1. Baseline Characteristics

    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

    Measured: Baseline, Day 0

  2. Incidence of Late and Chronic Treatment-Related Toxicity

    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.

    Measured: From 1 month after salvage brachytherapy to 48 months after treatment

  3. Local Relapse-Free Survival

    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.

    Measured: From the date of salvage brachytherapy to 48 months after treatment

  4. Incidence of Acute Treatment-Related Toxicity

    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.

    Measured: From the date of salvage brachytherapy to 1 month after treatment

  5. Change in International Prostate Symptom Score (IPSS) From Baseline

    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.

    Measured: Baseline and every 6 months after salvage brachytherapy through 48 months

  6. Change in Prostate Cancer-Specific Quality of Life (FACT-P) From Baseline

    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.

    Measured: Baseline and every 6 months after salvage brachytherapy through 48 months

  7. Change in Prostate Cancer-Specific Quality of Life (EORTC QLQ-PR25) From Baseline

    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..

    Measured: Baseline and every 6 months after salvage brachytherapy through 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2026
  2. Study start11 Mar 2026
  3. Primary completion31 Jan 2032 (estimated)
  4. Study completion30 Apr 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
63 participants (estimated)
Target duration
4 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07860528
Sponsor's protocol ID
PROSCATE
Acronym
PROSCATE
Status last verified
Oct 2026
First submitted
30 Sep 2026
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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