Clinical trials: Treatment-naive Prostate Cancer
Prostate Cancer
Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as luteinizing hormone-releasing hormone agonist, flutamide, and bicalutamide may stop the adrenal glands from producing androgens.
- Trial name
- NCT00030654
- Testing
- bicalutamide, docetaxel, doxorubicin hydrochloride
- Where
- 78 sites in United States, Australia and 2 more
- Volunteers
- 21 people
- Sponsor
- Radiation Therapy Oncology Group
Prostate Cancer
Phase 1A/1B Study of PSA/IL-2/GM-CSF Vaccine for Recurrent Prostate Cancer in Hormone Naive and Hormone Independent Patients
This study is investigating the safety and efficacy of a vaccine directed against prostate tumor cells. The researchers are interested in evaluating the safety and tolerability of the vaccine, and the effects of the vaccine on…
- Trial name
- PSA (NCT02058680)
- Testing
- PSA/IL-2/GM-CSF
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- OncBioMune Pharmaceuticals
Localized Prostate Carcinoma, Castration-Naive Prostate Cancer
Neoadjuvant ADT With TULSA in the Treatment of Intermediate Risk Prostate Cancer
Clinical studies have shown that magnetic resonance imaging-guided transurethral ultrasound ablation (TULSA) of the prostate is safe and effective. In the TULSA procedure, prostate tissue is killed by heating with ultrasound.
- Conditions
- Localized Prostate Carcinoma, Castration-Naive Prostate Cancer, Intermediate Risk Prostate Cancer, Prostate Cancer
- Trial name
- NeoADT-TULSA (NCT05917860)
- Testing
- Degarelix, MRI-guided transurethral ultrasound ablation (TULSA)
- Where
- Finland
- Volunteers
- 15 people
- Sponsor
- Turku University Hospital
Prostatic Neoplasms
Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy
The purpose of this study is to evaluate the efficacy, based on prostate-specific antigen (PSA) progression, of abiraterone acetate in participants with metastatic (spread of cancer cells from one part of the body to another)…
- Trial name
- NCT02217566
- Testing
- Abiraterone acetate, Prednisone, Androgen deprivation therapy (ADT)
- Where
- 4 sites in Brazil
- Volunteers
- 46 people
- Sponsor
- Janssen Research & Development, LLC
Prostate Cancer
ARMOR1: Study of TOK-001 to Treat Castration Resistant Prostate Cancer
The purpose of this study is to determine whether TOK-001 is safe and shows biological effect in the treatment of castration resistant prostate cancer (CRPC).
- Trial name
- ARMOR1 (NCT00959959)
- Testing
- TOK-001
- Where
- 8 sites in United States
- Volunteers
- 49 people
- Sponsor
- LTN PHARMACEUTICALS, INC.
Prostate Neoplasms
A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)
The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have…
- Trial name
- NCT01715285
- Testing
- Abiraterone acetate, Prednisone, Androgen deprivation therapy (ADT)
- Where
- 208 sites in Argentina, Australia and 31 more
- Volunteers
- 1,209 people
- Sponsor
- Janssen Research & Development, LLC
Castrate Resistant Prostate Cancer, Chemotherapy Naive Prostate Cancer
Pasireotide (SOM230) With or Without Everolimus in Treating Patients With Hormone Resistant, Chemotherapy Naive Prostate Cancer
This is an open label randomized phase II study for prostate cancer patients who have disease progression after hormonal therapy.
- Conditions
- Castrate Resistant Prostate Cancer, Chemotherapy Naive Prostate Cancer, Prostate Cancer
- Trial name
- NCT01313559
- Testing
- Pasireotide, Everolimus, Laboratory biomarker analysis
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Prostate Cancer
Radiomics of Treatment-naive Prostate Cancer Patients on Multiparametric MRI for Risk Stratification and Treatment Outcomes Predictions
Prostate cancers (PCA) are a heterogeneous group which include indolent tumors that has no clinical significance to very aggressive cancer that could result in morbidities and mortality.
- Trial name
- NCT06126172
- Testing
- Multiparametric magnetic resonance imaging (mpMRI)
- Where
- Taiwan
- Volunteers
- 125 people
- Sponsor
- Chang Gung Memorial Hospital
Prostate Cancer
ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer
This is an open label non-comparative controlled randomized phase II study. The experimental arm is the group receiving ODM-201. The group receiving androgen-deprivation therapy (ADT) is included as an internal control.
- Trial name
- NCT02972060
- Testing
- ODM-201, ADT
- Where
- 12 sites in Belgium, France and 2 more
- Volunteers
- 61 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Prostate Cancer
Terbium 161 PSMA in Lutetium-177 PSMA Naive Patients
In this study it is aimed to analyze the efficacy and safety of Tb-161 PSMA I\&T in the 7.4 GBq activity in a large patient group of Lu-177 PSMA naïve mCRPC patients.
- Trial name
- TeLuNa (NCT07441837)
- Testing
- Terbium 161- PSMA I&T
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Ankara University
Castration-Resistant Prostate Carcinoma, Metastatic Malignant Neoplasm in the Bone
Durvalumab and Tremelimumab in Treating Chemotherapy Naive Patients With Metastatic Castration-Resistant Prostate Cancer
This phase II trial studies the safety, tolerability and how well durvalumab and tremelimumab work in treating participants with castration-resistant prostate cancer who have not received chemotherapy (chemotherapy naïve) and has…
- Conditions
- Castration-Resistant Prostate Carcinoma, Metastatic Malignant Neoplasm in the Bone, Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8
- Trial name
- NCT03204812
- Testing
- Durvalumab, Tremelimumab
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- M.D. Anderson Cancer Center
Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma
Enzalutamide With Ribociclib in Treating Patients With Metastatic Castrate-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression
This phase Ib/II trial studies the safety, side effects, best dose, and effectiveness of ribociclib when given with enzalutamide in treating patients with castrate-resistant prostate cancer that has spread from the primary site…
- Conditions
- Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Carcinoma Metastatic in the Bone, Stage IV Prostate Cancer AJCC v7
- Trial name
- NCT02555189
- Testing
- Enzalutamide, Ribociclib, Laboratory Biomarker Analysis
- Where
- 4 sites in United States
- Volunteers
- 52 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Metastatic Prostate Cancer
A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer
This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient…
- Trial name
- PEACE1 (NCT01957436)
- Testing
- abiraterone acetate, radiotherapy, Androgen Deprivation Therapy
- Where
- 77 sites in Belgium, France and 5 more
- Volunteers
- 1,173 people
- Sponsor
- UNICANCER
Castration-resistant Prostate Cancer
The Role of Androgen Deprivation Treatment (ADT) in Docetaxe-Prednisolone Chemotherapy for Castrate-Resistant Prostatic Cancer
The purpose of this study is to assess the androgen deprivation therapy when patients with castration-resistant prostate cancer are treated with docetaxel-based chemotherapy.
- Trial name
- NCT01487902
- Testing
- ADT, No ADT
- Where
- South Korea
- Volunteers
- 90 people
- Sponsor
- Asan Medical Center
Metastatic Prostate Carcinoma, Prostate Adenocarcinoma
Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer
This phase II trial studies how well abiraterone acetate, prednisone, and apalutamide work in treating patients with hormone-naive prostate cancer that has spread to other places in the body.
- Conditions
- Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Prostate Carcinoma Metastatic in the Bone, Stage IV Prostate Cancer AJCC v8
- Trial name
- NCT03821792
- Testing
- Abiraterone Acetate, Apalutamide, Prednisone
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- M.D. Anderson Cancer Center
Biochemically Recurrent Prostate Cancer
A Study Called ARAMON to Learn to What Extent Does Study Treatment With Darolutamide Affects Testosterone Levels in Men With Prostate Cancer That Had Not Been Treated With Hormonal Therapy Compared to Treatment With Enzalutamide
Researchers are looking for a better way to treat men who have biochemically recurrent hormone-naïve prostate cancer. Hormone-naïve prostate cancer is a prostate cancer that has not yet been treated with hormonal therapy…
- Trial name
- ARAMON (NCT05526248)
- Testing
- Darolutamide(BAY1841788, Nubeqa), Enzalutamide
- Where
- 5 sites in United States
- Volunteers
- 28 people
- Sponsor
- Bayer
Metastatic Castration Resistant Prostate Cancer
Personalizing Enzalutamide Therapy by Understanding the Relation Between Tumor mRNAs, miRNAs and Treatment Response
The primary aim is to show whether a reduction in tumor related mRNAs and a panel of selected miRNAS can be used to personalize enzalutamide therapy.
- Trial name
- ILUMINATE (NCT02471469)
- Testing
- Enzalutamide, 160mg, 40 mg soft capsules, once daily
- Where
- 3 sites in Netherlands
- Volunteers
- 40 people
- Sponsor
- Radboud University Medical Center
Prostatic Neoplasms, Castration-Resistant
A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer
The purpose of this real-world study is to learn about the effects of 2 study medicines called enzalutamide and abiraterone used to treat metastatic castration-resistant prostate cancer (mCRPC).
- Trial name
- NCT05968599
- Testing
- Enzalutamide, Abiraterone acetate
- Where
- United States
- Volunteers
- 2,731 people
- Sponsor
- Pfizer
Prostatic Neoplasms
Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms
To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs…
- Trial name
- ERA 223 (NCT02043678)
- Testing
- Radium-223 dichloride (Xofigo, BAY88-8223), Abiraterone, Prednisone/Prednisolone
- Where
- 163 sites in United States, Australia and 17 more
- Volunteers
- 806 people
- Sponsor
- Bayer
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer
The purpose of this study is to evaluate the efficacy of [177Lu]Lu-PSMA-617 over a change of androgen receptor-directed therapy (ARDT) treatment in prolonging radiographic progression free survival (rPFS) in Chinese metastatic…
- Trial name
- NCT05658003
- Testing
- [177Lu]Lu-PSMA-617, ARDT, [68Ga]Ga-PSMA-11
- Where
- 15 sites in China
- Volunteers
- 63 people
- Sponsor
- Novartis Pharmaceuticals