Идёт набор NCT06235697

Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment

Фаза III С лечением Prostate Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Radiation, Radiation SBRT only, ADT.
Кому может быть актуально: Состояния в реестре: Prostate Cancer. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Androgen Suppression Combined With Elective Nodal Irradiation and Dose Escalated Prostate Treatment: A Non-Inferiority, Phase III Randomized Controlled Trial of Stereotactic Body Radiation Therapy Versus Brachytherapy Boost in Patients With Unfavourable Risk Localized Prostate Cancer

Обзор

This study is being done to answer the following question: Is the strategy to give higher doses of radiotherapy treatment over a shorter period of time using special equipment and fewer treatments (also known as Stereotactic Body Radiation Therapy or SBRT) as effective as usual external radiation therapy given with a brachytherapy boost (which involves radiation sources inserted directly into the prostate)?

Подробное описание

The usual approach for patients with unfavourable prostate cancer who are not in a study is treatment with external beam radiation therapy (EBRT) to the pelvis and prostate in combination with hormone therapy (androgen deprivation therapy - ADT). To improve control of prostate cancer at risk of returning, additional treatment with a brachytherapy boost (insertion of radiation sources directly into the prostate) is recommended. For patients who get the usual approach for this cancer, about 89 out of 100 are free of cancer after 5 years.

Вмешательства

Лучевая терапия Radiation
46Gy / 23 fractions of EBRT to pelvis and prostate + LDR or HDR boost to prostate OR 25Gy / 5 fractions of EBRT to pelvis and prostate (ultrahypofractionation EBRT (SBRT)) + LDR or HDR boost to prostate. \+ Adjuvant ADT: Unfavourable Intermediate Risk: 6 months or High / Very High Risk: 24 months
Лучевая терапия Radiation SBRT only
25Gy / 5 fractions to pelvis + 40 Gy / 5 fractions to prostate (SBRT) (ultrahypofractionation EBRT (SBRT))
Препарат ADT
Assigned at enrollment

Первичные конечные точки

To compare the progression-free survival (PFS) of SBRT versus conventional EBRT plus brachytherapy boost defined as time to biochemical failure, initiation of salvage therapy, local-regional recurrence, distant progression, or death [Срок оценки: 8.6 years]

Вторичные конечные точки (9)

Safety and tolerability assessed by CTCAE v5.0 [Срок оценки: 8.6 years]
PSA response at 4 years compared using a Cochran-Mantel-Haenszel (CMH) test [Срок оценки: 8.6 years]
Metastasis-free Survival compared using the Gray's test [Срок оценки: 8.6 years]
Cause-specific Survival compared using the Gray's test [Срок оценки: 8.6 years]
Overall Survival analysed using a Cox proportional hazards model and graphically described using the Kaplan-Meier method [Срок оценки: 8.6 years]
Participant-reported outcomes using EPIC-26 questionnaire [Срок оценки: 8.6 years]
Participant-reported tolerability using PRO-CTCAE questionnaire [Срок оценки: 8.6 years]
Economic Outcomes using EQ-5D-5L [Срок оценки: 8.6 years]
Economic Outcomes using FACIT-COST [Срок оценки: 8.6 years]

Критерии участия

Критерии включения

Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months
Participants with unfavourable risk prostate cancer are eligible according to the following NCCN classification guidelines (Version 4.2022 - May 10, 2022):

Unfavourable-intermediate risk - has one or more of the following:
2 or 3 Intermediate Risk Factors (IRFs): cT2b-cT2c, Gleason 7 (grade group 2 or 3), and/or PSA 10-20 ng/ml;
Gleason 4+3 (grade group 3)
> 50% biopsy cores positive

High risk - has one of the following:
cT3a
Gleason 8-10 (grade group 4 or 5)
PSA > 20 ng/ml

Very-high risk - has at least one of the following:
cT3b-cT4
Primary Gleason pattern 5
2 or 3 high risk features: cT3a, Gleason 8-10 (grade group 4 or 5), and/or PSA > 20 ng/ml
> 4 cores with Gleason 8-10 (grade group 4 or 5)
ECOG performance status of 0, 1 or 2
Participants must be ≥ 18 years of age
Judged to be medically fit for brachytherapy
Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English, French or Spanish
Participants consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate
Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up
In accordance with CCTG policy, protocol treatment is to begin within 12 weeks of participant enrollment
Participants must be willing to take precautions to prevent pregnancy while on study
ADT (LHRH agonists, antagonists, or anti-androgens) for prostate cancer is permitted for up to 30 days before study enrollment
5-alpha reductase inhibitors (5-ARI) are allowed, but baseline PSA will be corrected if 5-ARI use occurs within 6 months of enrollment
Participants may NOT have received other therapies including chemotherapy, PARPi, radioligand or other investigational drugs for prostate cancer
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Urinary function defined as International Prostate Symptom Score (IPSS) < 20. Alpha blockers are allowed to treat baseline urinary function
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

Критерии исключения

Prior pelvic radiotherapy
Contraindication to radical prostate radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)
Anticoagulation medication (if unsafe to discontinue for gold seed insertion or brachytherapy implant) and/or prior or current bleeding diathesis
Prior steam vaporization (Rezum), transurethral resection of the prostate (TURP), prostatectomy (simple or radical), or any ablative therapy to the prostate (cryotherapy, HIFU, TULSA, focal laser ablation, photodynamic therapy)
Prostate volume > 60cc before start of androgen deprivation therapy
Anatomy that would preclude precise brachytherapy implant (such as arch interference or large median lobe)
Evidence of castrate resistance (defined as a rising PSA > 3.0 ng/ml while testosterone is < 3.0 nmol/l)
Hip prosthesis (unilateral hip replacement is allowed if dose constrains can be reasonably achieved.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет