Prostate Cancer Clinical Trial
— CREATIVEOfficial title:
Systemic Therapy Combined With Cytoreductive Prostatectomy for the Treatment of de Novo Poly-metastatic Hormone Sensitive Prostate Cancer: A Prospective, Open-label Randomized Controlled Trial
Verified date | April 2024 |
Source | RenJi Hospital |
Contact | Liang Dong |
Phone | +86-13601613536 |
drdongliang[@]126.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this clinical trial is to compare systemic therapy combined with cytoreductive prostatectomy with standard of care (SOC) in de novo poly-metastatic hormone sensitive prostate cancer (de novo pmHSPC). The main questions it aims to answer are: 1. To explore the clinical benefit and safety of systemic therapy combined with cytoreductive prostatectomy for patients with de novo pmHSPC. 2. To explore the characteristics of the subgroup of patients who could benefit more from the above treatment. 3. To explore the relationship between stage efficacy and clinical prognosis. 4. To explore the correlation between molecular imaging such as PSMA-PET/CT and its changes with treatment efficacy. Participants will undergo systemic therapy combined with cytoreductive prostatectomy. Researchers will compare systemic therapy combined with cytoreductive prostatectomy with SOC to see the pros and cons of the two strategies.
Status | Recruiting |
Enrollment | 192 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2028 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. Fully understand the purpose of this trial and sign a written informed consent; 2. Men aged 18-85 years; 3. have histologically or cytologically confirmed adenocarcinoma of the prostate; 4. Have multiple metastatic disease, defined as follows: according to RECIST v1.1, metastatic disease was defined as metastatic foci detected on bone scans or measurable lymph nodes or soft tissue or visceral lesions above the aortic bifurcation. Lymph nodes were defined as measurable if their short-axis diameter was =15 mm; soft tissue/visceral lesions were defined as measurable if their long-axis diameter was =10 mm. and total number of metastatic lesions = 5. Patients with only regional lymph node metastases (N1, below the aortic bifurcation) were not eligible for the study. 5. At the investigator's discretion, patients must meet the indications for ADT and docetaxel; 6. Patients have not received any prior local or systemic therapy for prostate cancer primary or metastasis. 7. Eastern Cooperative Oncology Group (ECOG) score of 0-1; 8. Blood count at screening: hemoglobin = 9.0 g/dL, absolute neutrophil count = 1.5 x 10^9/L, and platelet count = 100 x 10^9/L (patient has not received any colony-stimulating factor within 4 weeks or a transfusion or blood product within 7 days prior to blood collection) 9. Serum alanine aminotransferase and/or aspartate aminotransferase = 1.5 x Upper limit of normal (ULN), total bilirubin = ULN, creatinine = 2.0 x ULN. Exclusion Criteria: 1. Prior therapy: ADT, second-generation androgen receptor inhibitors, CYP17 enzyme inhibitors, any chemotherapy or immunotherapy for prostate cancer, radiotherapy (external radiation radiotherapy, brachytherapy, or radiopharmaceuticals); 2. Known hypersensitivity to any of the investigational drugs, or excipients in the preparations; 3. Contraindication to CT/MRI examination; 4. Any of the following conditions within 6 months prior to randomization: stroke, myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass grafting, or congestive heart failure (New York Heart Association cardiac function class III or IV); 5. uncontrolled hypertension as evidenced by a resting systolic blood pressure = 160 mm Hg or diastolic blood pressure = 100 mm Hg after treatment 6. History of prior malignancy, except basal cell or cutaneous squamous cell carcinoma in complete remission; 7. History of gastrointestinal disorders or surgery expected to significantly interfere with the absorption of study drug(s); 8. Active acute and chronic viral hepatitis, known HIV infection; 9. Prior (28 days prior to initiation of study drug or 5 half-lives of investigational therapy from a prior study, whichever is longer) or concurrent participation in another clinical study of study drug; 10. Any other serious or unstable medical condition or condition that may interfere with their participation in the study or the evaluation of study results or may jeopardize the safety of the trial and other conditions; 11. Inability to swallow oral medications; 12. A close interest in the research center. |
Country | Name | City | State |
---|---|---|---|
China | Renji Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
RenJi Hospital |
China,
????????????, ????????. ???????????????(2019?). ????????. 2019;40(10):721-5.
?????????????, ???????????????????. ???(??????)???????????. ????????. 2020;25(7):575-84.
?????????????, ???????????????????. ????????????. ????????. 2019;24(5):336-46.
?????????????????????, ???????????????????. ?????????????. ????????. 2023;28(1):18-23,8.
Buelens S, Poelaert F, Claeys T, De Bleser E, Dhondt B, Verla W, Ost P, Rappe B, De Troyer B, Verbaeys C, Kimpe B, Billiet I, Plancke H, Fransis K, Willemen P, Ameye F, Decaestecker K, Lumen N. Multicentre, prospective study on local treatment of metastatic prostate cancer (LoMP study). BJU Int. 2022 Jun;129(6):699-707. doi: 10.1111/bju.15553. Epub 2021 Aug 8. — View Citation
Connor MJ, Shah TT, Horan G, Bevan CL, Winkler M, Ahmed HU. Cytoreductive treatment strategies for de novo metastatic prostate cancer. Nat Rev Clin Oncol. 2020 Mar;17(3):168-182. doi: 10.1038/s41571-019-0284-3. Epub 2019 Nov 11. — View Citation
Eastham JA, Heller G, Halabi S, Monk JP 3rd, Beltran H, Gleave M, Evans CP, Clinton SK, Szmulewitz RZ, Coleman J, Hillman DW, Watt CR, George S, Sanda MG, Hahn OM, Taplin ME, Parsons JK, Mohler JL, Small EJ, Morris MJ. Cancer and Leukemia Group B 90203 (Alliance): Radical Prostatectomy With or Without Neoadjuvant Chemohormonal Therapy in Localized, High-Risk Prostate Cancer. J Clin Oncol. 2020 Sep 10;38(26):3042-3050. doi: 10.1200/JCO.20.00315. Epub 2020 Jul 24. — View Citation
Efstathiou E, Davis JW, Pisters L, Li W, Wen S, McMullin RP, Gormley M, Ricci D, Titus M, Hoang A, Zurita AJ, Tran N, Peng W, Kheoh T, Molina A, Troncoso P, Logothetis CJ. Clinical and Biological Characterisation of Localised High-risk Prostate Cancer: Results of a Randomised Preoperative Study of a Luteinising Hormone-releasing Hormone Agonist with or Without Abiraterone Acetate plus Prednisone. Eur Urol. 2019 Oct;76(4):418-424. doi: 10.1016/j.eururo.2019.05.010. Epub 2019 Jun 6. — View Citation
Gratzke C, Engel J, Stief CG. Role of radical prostatectomy in metastatic prostate cancer: data from the Munich Cancer Registry. Eur Urol. 2014 Sep;66(3):602-3. doi: 10.1016/j.eururo.2014.04.009. Epub 2014 May 10. No abstract available. — View Citation
Heidenreich A, Pfister D, Porres D. Cytoreductive radical prostatectomy in patients with prostate cancer and low volume skeletal metastases: results of a feasibility and case-control study. J Urol. 2015 Mar;193(3):832-8. doi: 10.1016/j.juro.2014.09.089. Epub 2014 Sep 22. — View Citation
Mohler JL, Antonarakis ES, Armstrong AJ, D'Amico AV, Davis BJ, Dorff T, Eastham JA, Enke CA, Farrington TA, Higano CS, Horwitz EM, Hurwitz M, Ippolito JE, Kane CJ, Kuettel MR, Lang JM, McKenney J, Netto G, Penson DF, Plimack ER, Pow-Sang JM, Pugh TJ, Richey S, Roach M, Rosenfeld S, Schaeffer E, Shabsigh A, Small EJ, Spratt DE, Srinivas S, Tward J, Shead DA, Freedman-Cass DA. Prostate Cancer, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2019 May 1;17(5):479-505. doi: 10.6004/jnccn.2019.0023. — View Citation
Parker CC, James ND, Brawley CD, Clarke NW, Hoyle AP, Ali A, Ritchie AWS, Attard G, Chowdhury S, Cross W, Dearnaley DP, Gillessen S, Gilson C, Jones RJ, Langley RE, Malik ZI, Mason MD, Matheson D, Millman R, Russell JM, Thalmann GN, Amos CL, Alonzi R, Bahl A, Birtle A, Din O, Douis H, Eswar C, Gale J, Gannon MR, Jonnada S, Khaksar S, Lester JF, O'Sullivan JM, Parikh OA, Pedley ID, Pudney DM, Sheehan DJ, Srihari NN, Tran ATH, Parmar MKB, Sydes MR; Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) investigators. Radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE): a randomised controlled phase 3 trial. Lancet. 2018 Dec 1;392(10162):2353-2366. doi: 10.1016/S0140-6736(18)32486-3. Epub 2018 Oct 21. — View Citation
Ploussard G, Fossati N, Wiegel T, D'Amico A, Hofman MS, Gillessen S, Mottet N, Joniau S, Spratt DE. Management of Persistently Elevated Prostate-specific Antigen After Radical Prostatectomy: A Systematic Review of the Literature. Eur Urol Oncol. 2021 Apr;4(2):150-169. doi: 10.1016/j.euo.2021.01.001. Epub 2021 Feb 8. — View Citation
Pound CR, Partin AW, Epstein JI, Walsh PC. Prostate-specific antigen after anatomic radical retropubic prostatectomy. Patterns of recurrence and cancer control. Urol Clin North Am. 1997 May;24(2):395-406. doi: 10.1016/s0094-0143(05)70386-4. — View Citation
Powell IJ, Tangen CM, Miller GJ, Lowe BA, Haas G, Carroll PR, Osswald MB, DeVERE WHITE R, Thompson IM Jr, Crawford ED. Neoadjuvant therapy before radical prostatectomy for clinical T3/T4 carcinoma of the prostate: 5-year followup, Phase II Southwest Oncology Group Study 9109. J Urol. 2002 Nov;168(5):2016-9. doi: 10.1016/S0022-5347(05)64285-1. — View Citation
Schaeffer EM, Srinivas S, Adra N, An Y, Barocas D, Bitting R, Bryce A, Chapin B, Cheng HH, D'Amico AV, Desai N, Dorff T, Eastham JA, Farrington TA, Gao X, Gupta S, Guzzo T, Ippolito JE, Kuettel MR, Lang JM, Lotan T, McKay RR, Morgan T, Netto G, Pow-Sang JM, Reiter R, Roach M, Robin T, Rosenfeld S, Shabsigh A, Spratt D, Teply BA, Tward J, Valicenti R, Wong JK, Berardi RA, Shead DA, Freedman-Cass DA. NCCN Guidelines(R) Insights: Prostate Cancer, Version 1.2023. J Natl Compr Canc Netw. 2022 Dec;20(12):1288-1298. doi: 10.6004/jnccn.2022.0063. — View Citation
Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763. — View Citation
Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, Kopyltsov E, Park CH, Alekseev B, Montesa-Pino A, Ye D, Parnis F, Cruz F, Tammela TLJ, Suzuki H, Utriainen T, Fu C, Uemura M, Mendez-Vidal MJ, Maughan BL, Joensuu H, Thiele S, Li R, Kuss I, Tombal B; ARASENS Trial Investigators. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022 Mar 24;386(12):1132-1142. doi: 10.1056/NEJMoa2119115. Epub 2022 Feb 17. — View Citation
Trapasso JG, deKernion JB, Smith RB, Dorey F. The incidence and significance of detectable levels of serum prostate specific antigen after radical prostatectomy. J Urol. 1994 Nov;152(5 Pt 2):1821-5. doi: 10.1016/s0022-5347(17)32394-7. — View Citation
Xia C, Dong X, Li H, Cao M, Sun D, He S, Yang F, Yan X, Zhang S, Li N, Chen W. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl). 2022 Feb 9;135(5):584-590. doi: 10.1097/CM9.0000000000002108. — View Citation
* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Castration resistant-free survival | From date of randomization to the date of the following events, whichever occurs first: prostate specific antigen (PSA) elevation above nadir of at least 2 ng/mL or elevation above nadir of at least 25% when testosterone is at castration level (<50 ng/dL), as determined by reassessment at least 3 weeks later; or soft tissue, visceral, or radiographic progression of skeletal lesions: as recommended by the Prostate Cancer Clinical Trials Working Group (PCWG)3, Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 is applied via magnetic resonance imaging (MRI) of the thorax/abdomen/pelvis to determine radiographic progression of soft tissue/visceral lesions; bone metastases are identified separately from soft tissue/visceral metastases and are determined by 99mTc methylenediphosphonate bone scanning of the whole body according to PCWG3. Metastases may also be identified using PSMA-PET/CT. | Through study completion, assessed up to three years. | |
Secondary | Overall Survival | From date of randomization until the date of death from any cause. | Through study completion, assessed up to three years. | |
Secondary | PSA response | Complete remission is defined as PSA detectable (=0.2 ng/mL) at baseline and undetectable (<0.2 ng/mL) for the duration of the study; PSA50, and PSA90 response are defined as a =50% or =90% decrease in the measured PSA level from baseline to post-baseline as determined by reassessment after at least 3 weeks. | Through study completion, assessed up to three years. | |
Secondary | Symptomatic skeletal event | Defined as external radiation therapy for the relief of skeletal symptoms, a new symptomatic pathologic fracture or vertebral compression fracture or related orthopedic surgical intervention, or death, whichever occurred first. | Through study completion, assessed up to three years. | |
Secondary | Pain progression | Pain is assessed at each visit using the Visual Analogue Scale (VAS). Pain progression is defined as an increase of =2 points from the nadir of the worst pain score or opioid use for more than 7 consecutive days in two consecutive assessments =4 weeks apart for asymptomatic patients ("worst pain in 24 hours" score of 0 at baseline). For symptomatic patients (worst pain in 24 hours" score >0 at baseline), pain progression was defined as an increase of =2 points from the nadir of the worst pain score on two consecutive assessments =4 weeks apart and with a worst pain score of =4 or or initiation of short-acting or long-acting opioid therapy for cancer pain for more than 7 consecutive days. | Through study completion, assessed up to three years. | |
Secondary | Deterioration of disease-related somatic symptoms | According to the National Comprehensive Cancer Network/Functional Assessment of Cancer Care Prostate Cancer Symptom Index 17-item questionnaire (NCCN-FACT FPSI-17), worsening of disease-related somatic symptoms was defined as a 3-point decrease in the Disease-related Somatic Symptoms subscale (FPSI-DRS-P subscale) from baseline on two consecutive assessments =4 weeks apart. | Through study completion, assessed up to three years. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |