Table 5.
Selected clinical trials studying various therapies including systemic, surgical, and radiation interventions in high-risk prostate cancer.
| NCT ID # | Phase | Title | Accrual and arms | Treatment arms |
|---|---|---|---|---|
| Systemic therapy interventions | ||||
| NCT03477864 | 1 | Stereotactic body radiation therapy with REGN2810 and/or ipilimumab before surgery in treating participants with progressive advanced or oligometastatic prostate cancer | Active target enrollment: 24 three arms |
Anti-PD1 monoclonal antibody (REGN2810) vs. intraprostatic ipilimumab vs. a combination of both, followed by SBRT + RP |
| NCT02023463 | 1 | Enzalutamide, radiation therapy, and hormone therapy in treating patients with intermediate or high-risk prostate cancer | No longer recruiting actual enrollment: 25 one arm |
Enzalutamide + LHRH agonist with goserelin or leuprolide, followed by RT and additional LHRH agonist |
| NCT03177460 | 1 | Daratumumab or FMS inhibitor JNJ-40346527 before surgery in treating patients with high-risk, resectable localized or locally advanced prostate cancer | Active target enrollment: 30 two arms |
Daratumumab (CD38 antagonist) vs. FMS inhibitor JNJ-40346527(CSF-1R tyrosine kinase inhibitor) followed by RP |
| NCT00099086 | 1 | Docetaxel, radiation therapy, and hormone therapy in treating patients with locally advanced prostate cancer | No longer recruiting actual enrollment: 20 one arm |
RT + bicalutamide and GnRH analog prior to, during, and after RT + concurrent docetaxel |
| NCT03821246 | 2 | Neoadjuvant atezolizumab with or without enzalutamide in localized prostate cancer given before radical prostatectomy | Active target enrollment: 68 three arms |
Atezolizumab alone vs. in combination with enzalutamide or in combination with emactuzumab, followed by RP |
| NCT02506114 | 2 | Neoadjuvant PROSTVAC-VF with or without ipilimumab for prostate cancer | Active target enrollment: 75 two arms |
PROSTVAC-VF (PSA-based immunization) ± ipilimumab, followed by RP |
| NCT02508636 | 2 | Trial of radiotherapy with leuprolide and enzalutamide in high-risk prostate | No longer recruiting actual enrollment: 11 one arm |
Definitive RT + Leuprolide + Enzalutamide |
| NCT02772588 | 2 | AASUR in high-risk prostate cancer | Active target enrollment: 58 one arm |
Leuprolide + Abiraterone + apalutamide + SBRT |
| NCT02903368 | 2 | Neoadjuvant and adjuvant abiraterone acetate + apalutamide prostate cancer undergoing prostatectomy | No longer recruiting actual enrollment: 120 two arms, crossover |
Abiraterone, leuprolide, prednisone ± apalutamide, followed by RP. Adjuvant abiraterone, apalutamide, leuprolide, prednisone vs. no adjuvant therapy. |
| NCT03436654 | 2 | Multi-arm multi-modality therapy for very high-risk localized and low volume metastatic prostatic adenocarcinoma | Active target enrollment: 76 two arms |
Apalutamide ± (Abiraterone and prednisone) followed by RP, pelvic lymphadenectomy, GnRH agonist/antagonist |
| NCT03432780 | 2 | Radiation-hormone and docetaxel vs. radiation-hormone in patients with high-risk localized prostate cancer (QRT-SOGUG) | No longer recruiting actual enrollment: 134 two arms |
RT + hormone therapy ± weekly docetaxel |
| NCT01385059 | 2 | Axitinib before surgery in treating patients with high-risk prostate cancer | No longer recruiting actual enrollment: 60 two arms |
Axitinib for 28 days vs. no therapy followed by RP and pelvic lymph node dissection |
| NCT02849990 | 2 | A phase II neoadjuvant study of apalutamide, abiraterone acetate, prednisone, degarelix and indomethacin in men with localized prostate cancer pre-prostatectomy | No longer recruiting actual enrollment: 22 one arm |
Apalutamide, abiraterone, prednisone, degarelix, indomethacin followed by RP |
| NCT03899987 | 2 | Aspirin and rintatolimod with or without interferon-alpha 2b in treating patients with prostate cancer before surgery | Active target enrollment: 60 two arms |
Aspirin + rintatolimod ± recombinant interferon alpha-2b followed by RP vs. RP alone |
| NCT02949284 | 2 | Androgen receptor antagonist ARN-509 with or without abiraterone acetate, gonadotropin-releasing hormone analog, and prednisone in treating patients with high-risk prostate cancer undergoing surgery | Active target enrollment: 90 two arms |
Apalutamide ± (abiraterone acetate, GnRH agonist, prednisone) followed by RP vs. RP alone |
| NCT01409200 | 2 | Antiandrogen therapy with or without axitinib before surgery in treating patients with previously untreated prostate cancer with known or suspected lymph node metastasis | No longer recruiting actual enrollment: 73 two arms |
ADT + axitinib followed by RP and pelvic lymph node dissection vs. ADT alone followed by RP and pelvic lymph node dissection |
| NCT01546987 | 3 | Hormone therapy, radiation therapy, and steroid 17alpha-monooxygenase TAK-700 in treating patients with high-risk prostate cancer | No longer recruiting actual enrollment: 239 two arms |
ADT + GnRH agonist + RT ± TAK-700 (steroid 17alpha-monooxygenase) |
| NCT03767244 | 3 | A study of apalutamide in participants with high-risk, localized or locally advanced prostate cancer who are candidates for radical prostatectomy (PROTEUS) | Active target enrollment: 1,500 two arms |
ADT + apalutamide OR placebo, followed by RP, followed by adjuvant ADT + apalutamide OR placebo |
| NCT00288080 | 3 | Hormone therapy and radiation therapy or hormone therapy and radiation therapy followed by docetaxel and prednisone in treating patients with localized prostate cancer | No longer recruiting actual enrollment: 612 two arms |
Androgen suppression with LHRH agonist + oral anti-androgen prior to and concurrent with RT, followed by adjuvant LHRH agonist ± docetaxel x six cycles |
| NCT00430183 | 3 | Surgery with or without docetaxel and leuprolide or goserelin in treating patients with high-risk localized prostate cancer | No longer recruiting actual enrollment: 788 two arms |
Docetaxel + LHRH agonist + surgery vs. surgery alone |
| Surgical interventions | ||||
| NCT00007644 | 3 | Prostate cancer intervention vs. observation trial (PIVOT) | Results published; pending long-term results actual enrollment: 731 two arms | RP vs. observation |
| N/A | 3 | Radical prostatectomy or watchful waiting in early prostate cancer (SPCG-4) | Results published; pending long-term results actual enrollment: 695 two arms | Watchful waiting vs. RP |
| NCT02102477 | 3 | Surgery vs. radiotherapy for locally advanced prostate cancer (SPCG-15) | Active target enrollment: 1,200 two arms |
RP ± adjuvant or salvage RT, vs. RT with adjuvant ADT |
| Radiation therapy interventions | ||||
| NCT02830165 | 1 | Stereotactic body radiation therapy in treating patients with high-risk prostate cancer undergoing surgery | Active target enrollment: 12 one arm |
SBRT given over three fractions ~2–4 weeks prior to RP |
| NCT02346253 | 1 | 2 | High-dose brachytherapy in treating patients with prostate cancer | Active target enrollment: 163 one arm |
High-dose brachytherapy over two fractions + ADT |
| NCT00951535 | 2 | A prospective phase II dose-escalation study using IMRT for high-risk N0 M0 prostate cancer. ICORG 08-17 | No longer recruiting actual enrollment: 251 |
Dose-escalation study from baseline of 75.6 Gy up to a maximum of 81 Gy, depending on volume constraints |
| NCT01368588 | 3 | Androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer (RTOG 0924) | No longer recruiting actual enrollment: 2,592 two arms |
RT to prostate and seminal vesicles alone vs. whole-pelvis RT |
| NCT00967863 | 3 | Radiation therapy in treating patients receiving hormone therapy for prostate cancer (GETUG-AFU 18) | No longer recruiting actual enrollment: 500 two arms |
RT to 80 Gy vs. to 70 Gy given in conjunction with ADT |
| NCT00667888 | 3 | A phase III intensity radiotherapy dose-escalation for prostate cancer using hypofractionation | No longer recruiting actual enrollment: 225 two arms |
RT to 75.6 Gy in 42 fractions vs. RT to 72 Gy in 30 fractions |
| Other interventions | ||||
| NCT03514927 | 2 | High-intensity focused ultrasound in treating participants with intermediate and high-risk prostate cancer | Active target enrollment: 32 one arm |
High-intensity focused ultrasound (HIFU) followed by RP |
ADT, androgen deprivation therapy; Gy, gray; IMRT, intensity-modulated radiation therapy; LHRH, Luteinizing hormone-releasing hormone; PSA, prostate-specific antigen; RP, radical prostatectomy; RT, radiation therapy; SBRT, stereotactic body radiotherapy.