Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT06654336

Reclutamento in corso

RATIONAL: Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC)

Interventistico

Fase 2

Juravinski Cancer Centre

Sponsor: Ontario Clinical Oncology Group (OCOG)

Ultimo Aggiornamento: 13 marzo 2026
Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.

The goal of this study is to determine whether the addition of Androgen Deprivation Therapy (ADT) utilizing the study drug ELIGARD® to Recurrence- Directed Therapy (RDT) improves progression-free survival (PFS) compared to RDT alone in patients with early radio-recurrent oligo-metastatic castrate / hormone sensitive prostate cancer (romCSPC). Participants will be assessed at standard of care clinic visits every 3 months. The follow-up period is 36 months.

Mostra Descrizione Dettagliata

Categoria di Trattamento

Altri Non-Farmaci, Altri Farmaci

Mutazioni richieste

Nessuno

Studio Iniziato

30 marzo 2026

Ultimo Aggiornamento dello Sponsor

13 marzo 2026

Completamento Stimato

1 aprile 2031

Contatto dello studio

Nome:Lisa Rudd-Scott, RN BScN

Email:ruddl@mcmaster.ca

Telefono:905-527-2299

Nome:Daryl Solomon

Email:solomd5@mcmaster.ca

Telefono:905-527-2299

Idoneità

Criteri di Inclusione

1. Previous biopsy-proven localized prostate adenocarcinoma (without predominant features of sarcomatoid, small cell or neuroendocrine carcinoma) treated with definitive or salvage radiotherapy ≥ 2 years or more before enrollment.

2. Recurrent Oligo-metastatic CSPC, M0 on conventional imaging (bone scan and CT scan of chest/abdomen/pelvis) with ≤ 5 metastases cumulative on all imaging, including MRI and PSMA-PET.

Note: Patients with conventional imaging M1 oligometastatic CSPC, who have no more than 5 metastatic sites in all imaging modalities including MRI and PSMA-PET, will be accepted for study enrollment.

3. All sites of recurrent disease must be amenable to treatment with radiotherapy or surgery in the judgment of the investigator.

4. Biochemical recurrent prostate cancer with ONE of the following PSA recurrence definitions:

1. After definitive radiotherapy (prostate in situ), with PSA ≥ nadir + 2ng/ml;

2. After prostatectomy and adjuvant/salvage radiotherapy, with PSA ≥ nadir + 0.2ng/ml.

Criteri di Esclusione

1. Age < 18.

2. ECOG Performance Status ≥3.

3. PSA ≥ 20 ng/ml.

4. Treatment with ADT within 2 years from study enrollment or treatment with any androgen receptor axis within 6 months from study enrollment.

5. Prior treatment with chemotherapy for prostate cancer or bilateral orchiectomy. Note: prior chemotherapy for a different type of cancer is allowed if the patient has been continuously disease-free for > 3 years.

6. Intracranial or intrathecal metastasis.

7. Spinal cord compression, or spinal intramedullary metastasis.

8. Prior malignancy (except non metastatic, non- melanomatous skin cancer) unless disease free for > 3 years.

9. Bilateral hip prosthesis, treated earlier with definitive prostate radiotherapy, who have evidence of local disease recurrence within the prostate and no option for salvage treatment with brachytherapy or surgery.

10. Previous documented hypersensitivity to ELIGARD® or other GnRH agonist analogs of components of such preparations.

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Dettagli del Disegno

AllocazioneRandomized

Modello di InterventoParallel Assignment

MascheramentoNone (Open Label)

Numero da Arruolare162

Bracci e Interventi

Bracci

Interventi

Tipo: Experimental

Descrizione: Local, regional or distant oligometastatic RDT in addition to treatment with ADT for 12 months in the form of ELIGARD®.

Interventi:

Recurrence-directed therapy (RDT)
ELIGARD 22.5mg

Misure di Esito

Misure di Esito Primarie

Composite progression free survivalTime from randomization to the occurrence of composite PFS event occurring up to the 36 month follow-up.

Biochemical, radiological or clinical progression [composite PFS (cPFS) event]

Misure di Esito Secondarie

Disease progressionTime from date of randomization, until the date of progression or death occurring up to the 36 month follow-up.

Disease progression: time to biochemical progression (bPFS) (proportion of bPFS events); Disease progression: proportion of conventional-imaging based progression (rPFS) (proportion of rPFS events); Disease progression: proportion with eugonadal progression (egPFS)

Time to initiation of tertiary therapy;Time of initial therapy to 36 month follow-up.

Any non-protocol treatment given for prostate cancer after protocol-specified intervention.

Proportion of patients that develop castrate-resistant prostate cancer (CRPC)During the 36 month follow-up.

Proportion of patients that develop castrate-resistant prostate cancer (CRPC)

Overall survival.During the 36 month follow-up.

Overall survival.

Rate of early and late Grade 3 or higher GU and GI toxicity.At 3, 6, 15 and 36 months.

The rate of early and late Grade 3 or higher GU and GI toxicity will be assessed at baseline, 3, 6, 15 and 36 months. The CTCAEv.5.0 (> Grade 3, GI and GU) toxicity rates will be reported.

Quality of life assessed by EORTC QLQ C30Completed by the study participant at scheduled follow-up visits (Months 3, 6, 15 and 36).

Study participant reported quality of life utilizing the following measurement EORTC QLQ C30

Quality of life assessed by EORTC QLQ PR25 questionnaireCompleted by the study participant at scheduled follow-up visits (Months 3, 6, 15 and 36).

Quality of life assessed by EORTC QLQ PRT20 questionnaireCompleted by the study participant at scheduled follow-up visits (Months 3, 6, 15 and 36).

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Siti dello Studio

Questo studio ha 3 siti

Juravinski Cancer Centre

Hamilton, Ontario, CA

Nome:Theos Tsakiridis, Dr.

Email:tsakirid@hhsc.ca

Telefono:001-905-525-9140

In fase di reclutamento

Hamilton, Ontario, CA

Juravinski Cancer Centre

Non ancora in reclutamento

Ottawa, Ontario, K1H8L6 CA

The Ottawa Hospital Regional Cancer Centre

In fase di reclutamento

Montreal, Quebec, H1T2M4 CA

Jewish General Hospital

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