A Phase II, Open-label Study to Assess Safety and Clinical Utility of 68Ga-THP-PSMA PET/CT in Patients With High Risk Primary Prostate Cancer or Biochemical Recurrence After Radical Treatment (PRONOUNCED Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- Change in Patient Management
研究概览
简要总结
This will be an open-labelled, single centre study in the UK. The study group will include 60 patients with three groups of patients being studied. Group A will consist of 20 patients who have been newly diagnosed with primary high risk prostate cancer and are scheduled for radical prostatectomy surgery. Group B will consist of 20 patients with a diagnosis of BCR with previous radical prostatectomy, and are being considered for radical salvage therapy. Group C will consist of 20 patients with a diagnosis of BCR with previous radical radiotherapy (but no surgery), and are being considered for radical salvage therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Group A: Adenocarcinoma of the prostate gland suitable for radical Tx.
- •Adenocarcinoma of Prostate
- •Gleason score 4+3 and above, or PSA > 20 ng/mL or clinical stage >T2C.
- •Suitable for surgical tx
- •No Hormone Therapy in last 3 months
- •Group B: PCa and a diagnosis of BCR, previously treated with radical prostatectomy, being considered for radical salvage therapy (with curative intent).
- •Original diagnosis of PCa, treated with radical curative therapy at least 3 months before enrolment, and has been diagnosed with BCR based on:
- •Post RP: two consecutive rises in PSA and final PSA >0.lng/ml OR Post RP: three consecutive rises in PSA. This definition is also applicable to subjects with PSA persistence post RP (where the PSA fails to fall to undetectable levels).
- •Post RP: PSA doubling time of ~15 months OR PSA level 0.5 ng/ml.
- •No previous recurrences of PCa.
- •Consideration for radical salvage therapy.
- •Should not have received androgen-deprivation therapy within 3 months of screening.
- •No Hormone Therapy in last 3 months
- •Group C: PCa and a diagnosis of BCR, previously treated with radical radiotherapy, being considered for radical salvage therapy (with curative intent).
- •The subject has had an original diagnosis of PCa and underwent radical curative therapy at least 3 months before enrolment, and has been diagnosed with BCR on the basis of:
- •Increase in PSA level ~2.0 ng/ml above the nadir level after radiotherapy (RT) or brachytherapy, no previous recurrences of BCR.
- •The subject is being considered for radical salvage therapy.
- •Should not have received androgen-deprivation therapy within 3 months of screening.
- •No hormone therapy within the past three months.
排除标准
- •Prior Tx for Prostate Tumours
- •Gleason < 4+3
- •Hip prostheses
- •eGFR <20
- •Hormone Therapy in the last 3 months
- •Hip prostheses
- •eGFR <20
- •Hormone Therapy in the last 3 months
- •Hip prostheses
- •eGFR <20
研究组 & 干预措施
Gallium-68 THP-PSMA
Single intravenous administration of Gallium-68 THP-PSMA
干预措施: Gallium-68 THP-PSMA (Drug)
结局指标
主要结局
Change in Patient Management
时间窗: up to 3 months post PET/CT
The impact of 68Ga-THP-PSMA PET/CT on the management of patients with PCa was analysed by measuring the percentage of patients who had a change in management plan as a result of 68Ga-THP-PSMA PET/CT documented after scan, compared with their pre-scan management plan. A change status of 'Yes' was assigned if there was any difference in treatment options between the intended and revised management plans. A change status of 'No' was assigned if the intended and revised management plans remained identical. This endpoint was assessed in the full analysis set, but as a sensitivity analysis, was also assessed in the per protocol population in case there was a difference between the populations. As all 49 patients underwent a technically successful post-baseline scan, the full analysis set and per protocol populations were the same.
次要结局
- Safety - Treatment Emergent Adverse Events(Safety was assessed at screening, during the study and at Visit 4. AEs, regardless of relationship to study treatment, were recorded from the time of 68Ga-THP-PSMA administration until 30 days after the administration of 68Ga-THP-PSMA.)