NL-OMON52656招募中2 期
utetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer. - Bullseye-2
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 58
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Histological proven adenocarcinoma of the prostate with archived tumor
- •- Biochemical recurrence or clinical progression (PSA > 1.0 µg/l).
- •- ECOG 0-1.
- •- PSA-doubling time < 6 months.
- •- 18F-PSMA-PET-CT positive metastases in bones and/or lymph nodes (N1/M1ab):
- •>=1, maximally 5 metastases.
- •- Local treatment for oligometastases with radiotherapy or surgery appears to
- •be no option anymore (due to prior treatment or the location of the metastatic
- •- No prior hormonal therapy (including any androgen directed treatment such as
- •Bicalutamide, Apalutamide, Abiraterone or Enzalutamide) or taxane based
- •chemotherapy (docetaxel or cabazitaxel); testosterone > 1.7 nmol/l.
- •Exception: local prostate cancer treated with local radiotherapy plus adjuvant
- •ADT; these patients need to be stopped with ADT at least 6 months.
- •- No visceral metastases.
- •- Laboratory values:
- •White blood cells > 3.0 x 10^9/l
- •Platelet count > 75 x 10^9/l
- •Hemoglobin > 6.2 mmol/l
- •ASAT, ALAT < 3 x ULN
- •MDRD-GFR >= 50 ml/min
- •- Signed informed consent.
排除标准
- •- A detectable lesion on the 18F-PSMA PET/CT with significant PSMA avidity,
- •defined by a SUVmax > 10 (partial volume corrected).
- •- A known subtype other than prostate adenocarcinoma.
- •- Previous PSMA based radioligand treatment.
- •- Visceral or brain metastases.
- •- Any medical condition present that in the opinion of the investigator will
- •affect patients* clinical status when participating in this trial.
- •- Prior hip replacement surgery potentially influencing performance of PSMA
- •- Sjogren's syndrome.
- •- A second active malignancy other than prostate cancer.
- •- Patients who are sexually active and not willing/able to use medically
- •acceptable forms of barrier contraception.
研究者
相似试验
招募中
1 期
utetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer.prostate cancerCTIS2023-509881-39-00Stichting Radboud University Medical Center58
进行中（未招募）
1 期
utetium-177-PSMA therapy in metastatic prostate cancer.EUCTR2020-000076-37-CYRadboud University Medical Center58
招募中
2 期
Prostate-Specific Membrane Antigen (PSMA) Intensity Can be Altered by Androgen and phospho-SrC Obstructiometastatic castration-resistant prostate cancerCancer - ProstateACTRN12621000611820St Vincent's Hospital, Sydney22
Unknown
4 期
Radiolabeled Molecules for Medullary Thyroid CancerMedullary Thyroid CancerNCT01915485Instituto Nacional de Cancer, Brazil20
招募中
不适用
Metastatic hormone-sensitive and castration resistant prostate cancer registry: CAPRI 3.0NL-OMON24783Radboud University Medical Center10,000