Clinical trials: Hormone Sensitive Prostate Cancer, open to volunteers
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 Cance
A Novel Insight Into CRPC Progression and Immune: Evidence From Single-cell Spatial Transcriptome Multi-omics
This study will follow patients with metastatic hormone-sensitive prostate cancer (mHSPC) who receive androgen deprivation therapy (ADT) combined with different treatments.
- Trial name
- NCT07154914
- Testing
- Abiraterone + ADT
- Volunteers
- 396 people
- Sponsor
- Anhui Medical University
Castration Sensitive Prostate Cancer
A Feasibility Study Evaluating a Role for Maintenance Therapy in Patients With Biochemically Progressive Castration Sensitive Prostate Cancer on Intermittent Androgen Deprivation Therapy
The goal of this clinical trial is to assess the feasibility of adding a combination of metformin and turmeric as part of a nutritional intervention regimen to the current standard of care, namely, intermittent Androgen…
- Trial name
- NCT06044025
- Testing
- Metformin, Turmeric
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- University of Arkansas
Prostate Adenocarcinoma, Castration Sensitive Prostate Cancer
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)
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…
- Trial name
- RATIONAL (NCT06654336)
- Testing
- Recurrence-directed therapy (RDT), ELIGARD 22.5mg
- Where
- 5 sites in Canada
- Volunteers
- 162 people
- Sponsor
- Ontario Clinical Oncology Group (OCOG)
Prostate Cancer Metastatic
A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer
STAMPEDE2 is a clinical trial comparing two new treatments with standard of care in people with prostate cancer that has spread to other parts of the body and is responsive to hormone therapy.
- Trial name
- STAMPEDE2 (NCT06320067)
- Testing
- Stereotactic Ablative Body Radiotherapy (SABR), 177Lu-PSMA-617, Androgen Deprivation Therapy (ADT)
- Where
- 18 sites in United Kingdom
- Volunteers
- 3,360 people
- Sponsor
- University College, London
mHSPC, mHNPC
Safety and Efficacy Evaluation of LC-K76 in Patients With Metastatic Hormone-Sensitive Prostate Cancer
This study is a single-centre, randomised, paired 24-week intervention dosing trial. Its purpose is to evaluate the safety profile and efficacy of the investigational drug in subjects with metastatic hormone-sensitive prostate…
- Conditions
- mHSPC, mHNPC, Prostate Cancer Adenocarcinoma
- Trial name
- NCT07389174
- Testing
- Standard Endocrine Therapy, LC-K76
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Shanghai Changzheng Hospital
Castration-Sensitive Prostate Adenocarcinoma, Metastatic Castration-Sensitive Prostate Adenocarcinoma
Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Cancer, EQUIP Trial
This phase II trial compares giving estrogen with an androgen receptor signaling inhibitor to standard of care luteinizing hormone-releasing hormone (LHRH) analogues with an androgen receptor signaling inhibitor for improving…
- Conditions
- Castration-Sensitive Prostate Adenocarcinoma, Metastatic Castration-Sensitive Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
- Trial name
- NCT07466498
- Testing
- Androgen Receptor Pathway Inhibitor, Transdermal Estrogen, Bone Scan
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Fred Hutchinson Cancer Center
High Risk Localized Prostate Cancer, Synchronous Metastatic Hormone-Sensitive Prostate Cancer
Prospective Prostate Cancer Infrastructure
The goal of this observational study is to collect detailed long-term real-world data and biomaterials from men with high-risk localized prostate cancer and synchronous metastatic hormone-sensitive prostate cancer.
- Trial name
- ProPCI (NCT07560748)
- Where
- Netherlands
- Volunteers
- 700 people
- Sponsor
- Radboud University Medical Center
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
Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Adenocarcinoma
Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer
This phase II trial studies the effect of talazoparib with androgen deprivation therapy and abiraterone in treating castration sensitive prostate cancer patients.
- Conditions
- Castration-Sensitive Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
- Trial name
- NCT04734730
- Testing
- Abiraterone Acetate, Bicalutamide, Degarelix
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- City of Hope Medical Center
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
The purpose of this study is to evaluate the safety, tolerability, and efficacy of two different treatment combinations of tulmimetostat in participants with de novo or recurrent metastatic hormone-sensitive prostate cancer…
- Trial name
- TulmiSTAR-02 (NCT07190300)
- Testing
- Tulmimetostat, Darolutamide, Abiraterone
- Where
- 31 sites in United States, Australia and 12 more
- Volunteers
- 181 people
- Sponsor
- Novartis Pharmaceuticals
Prostate Cancer, Castration Sensitive Prostate Cancer
Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery
The purpose of this study is to characterize the reduction in PSMA-avid tumor volume and metastasis-directed radiotherapy treatment intensity facilitated by PET PSMA-response adapted SABR for poly-metastatic castration sensitive…
- Conditions
- Prostate Cancer, Castration Sensitive Prostate Cancer, Metastatic Prostate Cancer, Adaptive Radiotherapy
- Trial name
- RIPCORD (NCT07674771)
- Testing
- Drug: 68-Ga PSMA11, Adaptive stereotactic ablative radiotherapy (SABR), 68Ga-PSMA-11
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Texas Southwestern Medical Center
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
Recurrent Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial
This phase II trial tests leuprolide acetate alone versus in combination with 177Lu-PSMA-617, with or without abiraterone acetate and prednisone, for the treatment of hormone-sensitive prostate cancer has spread to a limited…
- Conditions
- Recurrent Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8, Castration-Sensitive Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
- Trial name
- SPARKLE (NCT07650240)
- Testing
- Abiraterone Acetate, Biospecimen Collection, Leuprolide Acetate
- Where
- United States
- Volunteers
- 202 people
- Sponsor
- Mayo Clinic
Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer
A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer
Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer. It works by reducing the amount of the main male sex hormone, testosterone in the body.
- Conditions
- Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer, Metastatic Hormone Sensitive Prostate Cancer
- Trial name
- NCT07005154
- Testing
- ASP5541, Prednisone, Prednisolone
- Where
- 54 sites in United States, China and 10 more
- Volunteers
- 218 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate
RYZ711 Diagnostic Platform Study
This is a Phase 1/2 multicenter, multi-cohort imaging study to evaluate the safety, tolerability, and diagnostic performance of RYZ711 positron emission tomography/computed tomography (PET/CT) in men with histologically confirmed…
- Conditions
- Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate, Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Trial name
- NCT07862582
- Testing
- RYZ711, PSMA PET/CT
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- RayzeBio, Inc.
Metastatic Hormone-sensitive Prostate Cancer
Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial.
This is a phase III, randomized, open-label, multi-center study to assess the efficacy of treatment intensification with docetaxel plus apalutamide and ADT, assessed by event-free survival, in patients with mHSPC who do not…
- Trial name
- REINFORCE (NCT07333066)
- Testing
- Apalutamide (Erleada™) 60 mg or 240 mg tablets, Docetaxel
- Where
- 56 sites in France, Germany and 3 more
- Volunteers
- 320 people
- Sponsor
- Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD
Metastatic Castration-resistant Prostate Neoplasms, Metastatic Hormone-sensitive Prostate Cancer
A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer
The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of pasritamig and combination regimens in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of pasritamig with the…
- Trial name
- NCT05818683
- Testing
- Pasritamig, Cetrelimab, Cabazitaxel
- Where
- 15 sites in United States, Australia and 1 more
- Volunteers
- 300 people
- Sponsor
- Janssen Research & Development, LLC
Prostate Cancer, Metastatic Cancer
PSA Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer
Prostate cancer remains the most common malignancy in men in Europe. Over the last two decades, the treatment landscape for both localized and metastatic prostate cancer has been revolutionized.
- Conditions
- Prostate Cancer, Metastatic Cancer, Castrate Sensitive Prostate Cancer
- Trial name
- PSA-DEEP02 (NCT06652607)
- Testing
- Enzalutamide, Apalutamide (Erleada™) 60 mg or 240 mg tablets, Darolutamide (Nubeqa®) 300 mg tablets
- Where
- Italy
- Volunteers
- 152 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Prostate Cancer
Evaluating Treatment Outcomes Using Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer.
This prospective clinical trial aims to investigate the impact of darolutamide in combination with standard-of-care androgen deprivation on physical activity, specifically step count, and its correlation with important markers of…
- Trial name
- NCT06660862
- Testing
- Darolutamide, Physician choice Androgen Deprivation (Hormone) Therapy
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- University of Chicago