Clinical trials: Metastatic Hormone Sensitive Prostate Cancer
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study).
This is a prospective, open-label, dose-escalation and randomized dose optimization and expansion study. The Phase Ib portion of the study aims to determine the safety and tolerability of escalating doses of [212Pb]Pb-ADVC001…
- Conditions
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Metastatic Hormone Sensitive Prostate Cancer
- Trial name
- NCT05720130
- Testing
- [²¹²Pb]Pb-ADVC001 (Phase 1b), [²¹²Pb]Pb-ADVC001 (Phase 2a)
- Where
- 3 sites in Australia
- Volunteers
- 100 people
- Sponsor
- AdvanCell Pty Limited
Prostate Adenocarcinoma, Prostate Cancer
Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression
The goal of this research study is to determine whether hormonal therapies used early in the course of prostate cancer could increase the amount of Prostate-Specific Membrane Antigen (PSMA) as detected by PET/CT scans for…
- Conditions
- Prostate Adenocarcinoma, Prostate Cancer, Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Trial name
- NCT05683964
- Testing
- Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi], Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Beth Israel Deaconess Medical Center
Metastatic Hormone-sensitive Prostate Cancer
Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may stop the adrenal glands from making androgens.
- Trial name
- CHAARTED (NCT00309985)
- Testing
- androgen-deprivation therapy, docetaxel
- Where
- 343 sites in United States
- Volunteers
- 790 people
- Sponsor
- ECOG-ACRIN Cancer Research Group
Metastatic Prostate Cancer, Prostate Cancer (Adenocarcinoma)
CONVERT-HB1: Radical Prostatectomy After Systemic Therapy for High-volume Metastatic Hormone-sensitive Prostate Cancer
This is a prospective, randomized, open-label, phase II multicenter clinical trial evaluating the efficacy and safety of radical prostatectomy in patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC) who…
- Conditions
- Metastatic Prostate Cancer, Prostate Cancer (Adenocarcinoma), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Trial name
- CONVERT-HB1 (NCT07268794)
- Testing
- Androgen Deprivation Therapy (ADT), Docetaxel, PARP Inhibitors and Other Systemic Agents
- Where
- China
- Volunteers
- 112 people
- Sponsor
- Fudan University
Metastatic Hormone-sensitive Prostate Cancer
Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive…
- Trial name
- ARASENS (NCT02799602)
- Testing
- BAY1841788 / darolutamide (ODM-201), Standard ADT (androgen deprivation therapy), Docetaxel
- Where
- 322 sites in United States, Australia and 21 more
- Volunteers
- 1,306 people
- Sponsor
- Bayer
Metastatic Prostate Cancer, Hormone Sensitive Prostate Cancer
PSMAtrack-tracking Changes in PSMA-PET During Initial Therapy for Metastatic Hormone-sensitive Prostate Cancer
The goal of this clinical trial is to learn if serial PSMA-PET/CT scans can be used to monitor response to therapy in metastatic hormone sensitive prostate cancer and can be potentially used to optimize future treatment…
- Conditions
- Metastatic Prostate Cancer, Hormone Sensitive Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
- Trial name
- NCT06479187
- Testing
- 18F-rhPSMA-7.3, PET/CT
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Brigham and Women's Hospital
Metastatic Hormone Sensitive Prostate Cancer
A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
The purpose of this study was to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review.
- Trial name
- ARCHES (NCT02677896)
- Testing
- Enzalutamide
- Where
- 203 sites in United States, Argentina and 22 more
- Volunteers
- 1,150 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients
The ADAPT study is an observational study of apalutamide, which can be given to patients with hormone sensitive metastatic prostate cancer as standard of care.
- Trial name
- ADAPT-P (NCT06019676)
- Where
- 12 sites in United Kingdom
- Volunteers
- 170 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Multimodal Approach in Patients With mHSPC. Randomized Trial of APA+ADT vs APA-ADT and Local Treatment
Italian multicenter study, will enroll ~566 pts with oligometastatic hormone sensitive prostate cancer who are candidates to receive treatment with apalutamide.
- Trial name
- APPROACH (NCT05649943)
- Testing
- APA + ADT, Local Treatmetn RT or RP
- Where
- 3 sites in Italy
- Volunteers
- 566 people
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Metastatic Hormone-sensitive Prostate Cancer, Darolutamide (DARO) in Combination With Androgen-deprivation Therapy (ADT) and Docetaxel (DOC)
Evaluation of the Efficacy of Darolutamide Triplet Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer
The purpose of this study is to investigate the clinical efficacy and safety of darolutamide combined with androgen deprivation therapy (ADT) and different dose-intensity docetaxel chemotherapy in the treatment of patients with…
- Trial name
- NCT07031258
- Testing
- Dose of docetaxel
- Volunteers
- 50 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Prostate Cancer
Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer
The purpose of this study is to study the effects of EPI-7386 in combination with Enzalutamide on participants diagnosed with prostate cancer.
- Conditions
- Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Prostate Cancer, Prostate Adenocarcinoma
- Trial name
- NCT06312670
- Testing
- EPI-7386, Enzalutamide, Androgen Deprivation Therapy (ADT)
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Pedro Barata, MD, MSc
Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer
ProBio is an international, outcome-adaptive, multi-arm, open-label, multiple assignment randomized biomarker driven platform trial in patients with metastatic prostate cancer.
- Trial name
- ProBio (NCT03903835)
- Testing
- Enzalutamide Oral Capsule, Abiraterone Oral Tablet, Carboplatin
- Where
- 32 sites in Belgium, Norway and 2 more
- Volunteers
- 750 people
- Sponsor
- Karolinska Institutet
Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer
Survey Based Discrete Choice Experiment Study in Prostate Cancer (DECIDER) Study
The purpose of this study is to quantify and publish participants' relative preferences for outcomes of chemotherapy and novel oral hormonal agents when added to androgen deprivation therapy (ADT) for participants with…
- Trial name
- NCT05381311
- Where
- United States
- Volunteers
- 1,020 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Hormone-Sensitive Prostate Cancer
Non-Interventional Study to Establish Consensus on Management of Metastatic Hormone-Sensitive Prostate Cancer Patients
The purpose of this study is to establish an expert consensus recommendations on managing patients with mHSPC in South Korea, and to provide clinicians with a comprehensive guide to support their clinical decision making.
- Trial name
- NCT06452212
- Testing
- No Intervention
- Where
- South Korea
- Volunteers
- 23 people
- Sponsor
- Astellas Pharma Korea, Inc.
Metastatic Hormone-sensitive Prostate Cancer
An Observational Study to Learn More About the Use of Darolutamide as a Part of a Combination Therapy in Belgian Men With Metastatic Hormone-Sensitive Prostate Cancer in Routine Medical Care
This is an observational study in which only observations from routine clinical practices will be made. Participants will not receive any advice on treatment or any changes to healthcare as a part of the study.
- Trial name
- BELBEQA (NCT06498921)
- Testing
- Darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxel
- Where
- Belgium
- Volunteers
- 106 people
- Sponsor
- Bayer
Prostate Cancer, Prostate Cancer Recurrent
Metastasis-directed Therapy for Oligorecurrent Prostate Cancer
The aim is to investigate whether the addition of short-term androgen deprivation therapy (ADT) during 1 month or short-term ADT during 6 months together with an androgen receptor targeted therapy (ARTA) to metastasis-directed…
- Conditions
- Prostate Cancer, Prostate Cancer Recurrent, Prostate Cancer Metastatic, Metastatic Cancer
- Trial name
- SPARKLE (NCT05352178)
- Testing
- Radiotherapy (SBRT) and/or surgery (metastasectomy), Androgen deprivation therapy, Androgen receptor targeted therapy
- Where
- Belgium
- Volunteers
- 873 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Prostate Cancer, Hormone Sensitive Prostate Cancer
Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients
The aim of this observational study is to evaluate the clinical outcomes of treatment with docetaxel, ARTA (alone or in combination) or with radiotherapy on the primary tumor for mCSPC, in an unselected population, in clinical…
- Conditions
- Prostate Cancer, Hormone Sensitive Prostate Cancer, Metastatic Tumor
- Trial name
- ECHOS (NCT06473259)
- Testing
- Docetaxel, Apalutamide Oral Tablet, Enzalutamide Oral Tablet
- Where
- 3 sites in Italy
- Volunteers
- 3,000 people
- Sponsor
- Santa Chiara Hospital
Metastatic Castrate Resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
The Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC
This was a multiple-center, open-label, randomized, daily dose, two-sequence, expanded/phase II study in subjects with mHSPC or mCRPC who progressed after either abiraterone or enzalutamide treatment.
- Trial name
- NCT03899467
- Testing
- GT0918
- Where
- 10 sites in United States
- Volunteers
- 61 people
- Sponsor
- Suzhou Kintor Pharmaceutical Inc,
Prostate Cancer, Metastatic Cancer
Effect of Low-dose 500 mg Abiraterone Acetate in Treatment of Metastatic Prostate Cancer Patients
This will be an open label, Phase I study to assess the efficacy of a reduced 500 mg dose of abiraterone acetate in patients with metastatic prostate cancer.
- Conditions
- Prostate Cancer, Metastatic Cancer, Hormone Sensitive Prostate Cancer, Castration-resistant Prostate Cancer
- Trial name
- NCT06193993
- Testing
- Abiraterone Acetate
- Where
- Singapore
- Volunteers
- 10 people
- Sponsor
- National University Hospital, Singapore
Metastatic Hormone-Sensitive Prostate Cancer
Rezvilutamide Plus Abiraterone for Metastatic Hormone-sensitive Prostate Cancer
This multicenter, prospective, cohort study enrolled patients with metastatic hormone-sensitive prostate cancer who had been treated with other novel endocrine or systemic regimens (excluding patients treated with pre-order…
- Trial name
- RASTOM (NCT06134271)
- Testing
- Rezvilutamide, Rezvilutamide plus abiraterone, Continue previous treatment
- Volunteers
- 160 people
- Sponsor
- Jianbin Bi