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MR-guided Single-fraction SBRT for Nodal Oligorecurrent Prostate Cancer (PINPOINT) (PINPOINT)

11 de junho de 2026 atualizado por: Odense University Hospital

Improved MR-Guided Single-fraction Stereotactic Sblative Radiotherapy in Pelvic and Abdominal Nodal Oliorecurrent Prostate Cancer

This single-arm phase 2 trial investigates whether a single high-dose radiotherapy treatment can safely treat men whose prostate cancer has come back in a small number of lymph nodes in the pelvis or abdomen after curative treatment. Participants receive one fraction of 24 Gy delivered with MR-guided stereotactic body radiotherapy (SBRT), which uses MRI to visualise the tumour and surrounding organs during treatment. The main goal is to assess safety (severe side effects). The trial also evaluates local tumour control, longer-term side effects, time until hormone (androgen deprivation) therapy is needed, survival, and quality of life. The trial aims to enrol 48 patients.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

PINPOINT is a prospective, investigator-initiated, single-centre, single-arm phase 2 trial of single-fraction MR-guided SBRT in patients with nodal oligorecurrent prostate cancer. Eligible men have PSMA-PET/CT-verified nodal relapse in the pelvis or abdomen following curatively intended local treatment.

All patients are simulated with MRI in treatment position and treated with 24 Gy in 1 fraction to the gross tumour volume (GTV) using inverse-planned step-and-shoot IMRT on an MR-linac. No CTV margin is added (CTV = GTV); PTV margins account for motion and set-up uncertainty. Normal-tissue constraints are prioritised over target coverage.

The primary endpoint is cumulative CTCAE v5 grade ≥4 treatment-related toxicity within 6 months. Sample size follows a Simon two-stage design (H0: grade 4-5 TRAE rate 15%; H1: 4%; one-sided α = 5%, power 80%), with an interim analysis after 6-month follow-up of the first 16 patients and a total of 48 patients. Follow-up continues for 5 years. Toxicity (CTCAE v5), quality of life (EQ-5D-5L, EORTC QLQ-C30) and patient-reported outcomes (PRO-CTCAE) are collected at baseline and through follow-up; PSA and PSMA-PET/CT (on rising PSA) follow standard of care.

Tipo de estudo

Intervencional

Inscrição (Estimado)

48

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Age ≥ 18 years
  • Signed informed consent
  • Histologically proven initial diagnosis of adenocarcinoma of the prostate
  • ECOG performance status 0-2
  • Biochemical recurrence after curatively intended local treatment (radical prostatectomy and/or radiotherapy), with PSMA-PET/CT-verified nodal relapse in the pelvis or abdomen
  • Any additional sites of disease beyond the protocol-specified target lymph nodes must be considered suitable for ablative treatment
  • Life expectancy > 6 months
  • Lymph node size ≤ 2 cm

Exclusion Criteria:

  • Medical contraindications to MRI
  • Inability to tolerate the physical set-up required for SABR
  • Overlap between prior radiation fields and the current target area leading to high risk of clinically significant normal-tissue injury
  • Contraindications to pelvic radiotherapy (chronic pelvic inflammatory bowel disease)
  • Uncontrolled intercurrent illness

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Single-fraction MR-guided SBRT
All participants receive 24 Gy in a single fraction to the GTV, delivered with MR-guided SBRT.
Radiação: Single-fraction SBRT
Participants will receive 24 Gy in 1 fraction to a lymph node.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Participants with cumulative CTCAE v5.0 grade ≥4 treatment-related adverse events
Prazo: Within 6 months after completion of radiotherapy
The NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 measures side-effects. Possible scores range from 0-5, with higher scores indicating a worse outcome.
Within 6 months after completion of radiotherapy

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of participants with late adverse events (CTCAE v5.0)
Prazo: 1, 1,5, 2, 3 and 5 years

The NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 measures side-effect.

Possible scores range from 0-5, with higher scores indicating a worse outcome.
1, 1,5, 2, 3 and 5 years
Percentage of participants free from local progression (PSMA-PET/CT-verified), estimated by time-to-event analysis
Prazo: From radiotherapy until local progression or last follow-up, up to 5 years
Defined as freedom from PSMA-verified relapse within the treated area. In the case of significant increase in PSA, a PSMA will be performed as to local guidelines. Local control will be evaluated at a lesion level, lesion by lesion. Within the treated area is defined as within or adjacent to the planning target volume (PTV).
From radiotherapy until local progression or last follow-up, up to 5 years
Median clinical progression-free survival
Prazo: From radiotherapy up to 5 years
Defined as time from inclusion to any new node or distant metastases recurrence.
From radiotherapy up to 5 years
Median time to initiation of palliative ADT (ADT-free survival)
Prazo: From inclusion up to 5 years
ADT-free survival is defined as the time from trial randomization to start of hormonal treatment
From inclusion up to 5 years
Number of participants with acute adverse events (CTCAE v5.0), by maximum grade
Prazo: Within 6 months after radiotherapy
The NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 measures side-effects. Possible scores range from 0-5, with higher scores indicating a worse outcome.
Within 6 months after radiotherapy
Median overall survival
Prazo: From inclusion up to 5 years
Overall survival is defined as time form inclusion to death from any cause
From inclusion up to 5 years
Mean change from baseline in EQ-5D-5L index (utility) score
Prazo: Baseline, 2 weeks, 3,6 and 12 months
The EQ-5D-5L is a standardized, validated generic instrument for health-related quality of life. It comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five response levels. Responses are converted to a single summary index (utility) score using a country-specific (Danish) value set, anchored at 1 = full health and 0 = death, with negative values possible for health states considered worse than death; higher scores indicate better health-related quality of life. The outcome is reported as the mean change from baseline in the EQ-5D-5L index score at each assessment time point.
Baseline, 2 weeks, 3,6 and 12 months
Mean change from baseline in EORTC QLQ-C30 Global Health Status / QoL scale score
Prazo: Baseline, 2 weeks, 3, 6 and 12 months
The EORTC QLQ-C30 (version 3.0) is a validated cancer-specific questionnaire for assessing health-related quality of life in clinical trials. It contains 30 items comprising a global health status / quality of life scale, five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), and several single-item symptom and financial-impact measures. Raw scores are linearly transformed to a 0-100 scale according to the EORTC scoring manual; for the global health status / QoL scale a higher score indicates better quality of life. This outcome is reported as the mean change from baseline in the global health status / QoL scale score at each assessment time point.
Baseline, 2 weeks, 3, 6 and 12 months
Number of participants reporting symptomatic adverse events as assessed by PRO-CTCAE
Prazo: Baseline, 2 weeks, 3,6 and 12 months
PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) is a validated patient-reported measurement system developed by the NCI to capture symptomatic toxicity in cancer clinical trials. A predefined subset of PRO-CTCAE items is used in this trial. Each symptom is rated by the patient over the prior 7 days across the applicable attributes - frequency (never to almost constantly), severity (none to very severe), and/or interference with usual or daily activities (not at all to very much) - each on a 5-point ordinal scale (scored 0-4). The outcome is reported as the number of participants in each response category per item and attribute at each assessment time point.
Baseline, 2 weeks, 3,6 and 12 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Odense University Hospital

Colaboradores

Danish Cancer Society

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de abril de 2030

Conclusão do estudo (Estimado)

1 de setembro de 2035

Datas de inscrição no estudo

Enviado pela primeira vez

3 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de junho de 2026

Primeira postagem (Real)

9 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • OP-2499
  • S-20250058 (Outro identificador: Ethics committee)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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