Real-world analysis of prostate-specific antigen (PSA) outcomes among patients with metastatic castration-resistant prostate cancer (mCRPC) treated with enzalutamide (ENZA).

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 33-33
Author(s):  
Stephen J. Freedland ◽  
Neil M. Schultz ◽  
Anna D. Coutinho ◽  
Rupali Fuldeore ◽  
Nancy Hedlund ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Median Time ◽  
Real World ◽  
Index Date ◽  
Clinical Trial Setting ◽  
Psa Response ◽  
Psa Progression ◽  
Trial Setting ◽  
Baseline Psa

33 Background: ENZA showed efficacy in chemotherapy-naïve men with mCRPC in a clinical trial setting (PREVAIL). We report real-world outcomes with ENZA for this population in a urology practice setting. Methods: This retrospective cohort study included men with prostate cancer newly initiating ENZA in the IntrinsiQ Specialty Solutions™ urology electronic medical records database between September 1, 2014 and February 28, 2018. Due to the approved indication in the study time frame, prescription of ENZA (first claim date = index date) was used as a proxy for mCRPC. Patients with evidence of prior chemotherapy and/or abiraterone were excluded. PSA value closest to index date (±30 days) was used as baseline. Men were followed until the earliest of: discontinuing ENZA, leaving practice, death, or study end. Best PSA response (largest decline or smallest increase in absence of decline from baseline), PSA declines of ≥50% and ≥90%, undetectable PSA, and time to PSA progression were analyzed. Results: We identified 931 eligible men. Most (>95%) were ≥60 years old; hypertension (54.6%) and diabetes (17.0%) were the most common comorbidities. Median (interquartile range [IQR]) baseline PSA was 9.0 (2, 37) ng/dL. Median (IQR) follow-up time was 12.5 (7.6, 19.4) months, during which a median (IQR) of 4 (3, 6) PSA tests were observed. Median time between two adjacent PSA tests was 2.0 months. A ≥50% and ≥90% PSA decline was observed in 55.0% and 23.8%, respectively. Best PSA response was a median (IQR) PSA decline of 58% (-89%, 1%), with 14.2% reaching an undetectable PSA value. Median time to PSA progression was 18.5 months (95% confidence interval 15.6, 23.7). Conclusions: This real-world study supports the effectiveness of ENZA in patients with mCRPC. The median PSA at treatment was much lower than PREVAIL, potentially explaining the longer time to PSA progression vs. PREVAIL. However, a lower proportion had PSA declines of ≥50% and ≥90% vs. PREVAIL, which may be attributed to more frequent PSA monitoring within a clinical trial setting and thus more opportunity to capture the true best PSA response.

Efficacy of abiraterone and enzalutamide in patients who had disease progression within twelve months of completing docetaxel for metastatic castration sensitive prostate cancer.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 241-241
Author(s):  
Gang Chen ◽  
David James VanderWeele ◽  
Fatima Karzai ◽  
Marijo Bilusic ◽  
Munjid Al Harthy ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Specific Antigen ◽  
Response Duration ◽  
Optimal Timing ◽  
Castration Resistant Prostate Cancer ◽  
Duration Of Treatment ◽  
Psa Response ◽  
Psa Progression ◽  
Low Volume

241 Background: Docetaxel is a standard of care for mCSPC. Enzalutamide and abiraterone have been proven to improve survival in metastatic castration-resistant prostate cancer (mCRPC) patients. Little is known about patients who have been treated with docetaxel for mCSPC and subsequent therapeutic responses. This retrospective analysis is to evaluate the response duration of abiraterone and enzalutamide in patients who previously received docetaxel for mCSPC but developed mCRPC within 12 months. Methods: Clinical Trial NCT02649855 enrolled patients with newly diagnosed mCSPC who were treated with standard androgen deprivation therapy (ADT) and docetaxel (75 mg/m2 every 3 weeks for 6 cycles) sequenced with immunotherapy (PROSTVAC) from February 2016 to present. Patients who had progression (based on consecutive PSA rises or imaging) within 1 year of completing docetaxel and went on to subsequent abiraterone/enzalutamide were evaluated. (Note these are different PSA progression criteria than used in CHAARTED, Sweeney, NEJM, 2015). Results: Of the 46 patients evaluated regardless of immunotherapy sequence, 15 (33%) went on subsequent therapy after progression on docetaxel for mCSPC, with 12 patients starting abiraterone/enzalutamide (6 each with high and low volume disease). The median age was 62 (41-83) years. 7/12 patients (58.3%) initiated enzalutamide and 5/12 patients (41.7%) initiated abiraterone. The median duration of treatment for both was 7.12 (1.53–16.0) months, the median time to prostate-specific antigen (PSA) progression was 5.54 (0–15.83) months; 5/12 (41.7%) of patients did not have PSA response. Of note, patients with low volume disease had a median treatment duration of 5.88 months, 3 of them did not have PSA response. Conclusions: These data from a small cohort suggest that patients who have progression within 12 months of completing docetaxel for mCSPC have limited subsequent benefit from enzalutamide or abiraterone. Additional studies are required to determine optimal timing and treatment sequence for patients with mCSPC who rapidly develop mCRPC. Clinical trial information: NCT02649855.

Randomized phase II trial of docetaxel plus prednisolone with or without androgen deprivation treatment in castration-resistant prostate cancer.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 217-217
Author(s):  
Jae Ho Jeong ◽  
Hyejung Hyun ◽  
In Gab Jeong ◽  
Jun Hyuk Hong ◽  
Hanjong Ahn ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Clinical Outcomes ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Randomized Phase Ii ◽  
Psa Response ◽  
Psa Progression ◽  
The Impact ◽  
Clinical Trial Information

217 Background: Androgen deprivation therapy (ADT) has been the main treatment option for patients with locally advanced or metastatic prostate carcinoma. However, the impact of continued ADT on clinical outcomes in castration-resistant prostate cancer (CRPC) patients treated with cytotoxic chemotherapy is controversial. We conducted a randomized phase II study to assess the impact of continued ADT in patients with CRPC receiving docetaxel plus prednisolone chemotherapy. Methods: Patients with CRPC were randomly assigned (in a 1:1 ratio) to receive docetaxel (75mg/m2 every 3 weeks) plus prednisolone (5mg twice daily on days 1-21) with ADT (leuprolide 11.25 mg long-acting depo every 12 weeks, ADT group) and docetaxel plus prednisolone without ADT (No-ADT group). For patients in the No-ADT group, ADT was resumed at the end of chemotherapy. The primary endpoint was time to PSA progression. Secondary objectives included PSA response rates, progression-free survival (PFS), and overall survival (OS). Suspension of leuprolide support prevented the attainment of our original goal of enrolling 80 men. Results: Between April 2011 and July 2014, 45 patients were enrolled in this study; 23 patients were randomly assigned to the ADT group and 22 to the No-ADT group. The median age was 68 years (range = 49-81) and median baseline serum PSA was 60.3 ng/mL (interquartile range = 14.7-157.3). Time to PSA progression was 6.5 months in ADT group and 4.3 months in No-ADT group, respectively (P = 0.673). PSA response rates were 55.2% and 44.8% in the ADT group and the No-ADT group, respectively (P = 0.463). The median PFS and OS were 5.3 months and 19.4 months for ADT patients and 4.3 months and 20.8 months for No-ADT patients, respectively (P = 0.608, P = 0.635). The testosterone level rose to more than the castrate level in 5 (22.7%) patients of the No-ADT group. Conclusions: Clinical outcomes were not significantly different when patients with CRPC received concurrent ADT, or were not so treated, when receiving docetaxel plus prednisolone chemotherapy. Clinical trial information: NCT01487902 Clinical trial information: NCT01487902.

A phase II study to evaluate the effects of docetaxel plus lycopene in advanced castrate-resistant prostate cancer.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 77-77
Author(s):  
Eric Zhuang ◽  
Edward M. Uchio ◽  
Michael B. Lilly ◽  
John P. Fruehauf
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Median Time ◽  
Response Rate ◽  
Phase Ii Study ◽  
Duration Of Response ◽  
Psa Response ◽  
Castrate Resistant Prostate Cancer ◽  
Psa Progression ◽  
Castrate Resistant

77 Background: Lycopene, the carotenoid responsible for the red colors seen in tomatoes, grapefruit, and other foods, has demonstrated synergism with docetaxel in prostate cancer cell culture and tumor xenograft models. This phase II study investigated the clinical activity and safety profile of docetaxel plus lycopene in advanced castrate resistant prostate cancer. Methods: Eligible patients had histologically confirmed adenocarcinoma of the prostate, two rising pre-study prostate specific antigen (PSA) values ≥ 1 ng/ml, and no prior treatment with any chemotherapy, biological therapy, or investigational drug. All patients initially received docetaxel 75mg/m2 every 21 days in combination with lycopene 30 mg orally once daily. The primary endpoint was PSA response rate, defined as the proportion of subjects achieving a ≥ 50% reduction in PSA at any point after starting therapy. Secondary endpoints included median time to PSA progression, duration of response (DOR), and overall survival (OS). Results: Fourteen patients were screened, and thirteen patients were initiated on protocol therapy. Median age was 77 years (range 55-90). Twelve patients (92%) had bone metastases. Four patients (30%) had bone and visceral metastases. The PSA response rate was 76.9% [95% confidence interval (CI), 46.2-94.9], comprising of ten PSA responses. Two patients had a best response of stable disease, yielding a disease control rate of 92% [95% CI, 57.2-98.2]. Median time to PSA progression was 8 months [95% CI, 3.5-8.7]. Median duration of response was 7.3 months [95% CI, 4.8-13.2]. On 5-year follow-up, median overall survival was 35.1 months [95% CI, 25.7-57.7]. The most frequently reported ( > 15%) non-hematologic adverse events included diarrhea, nausea, vomiting, peripheral neuropathy, weight loss, fatigue, onycholysis, and alopecia. One patient (7%) experienced febrile neutropenia. No patients experienced grade 3 or above anemia. Conclusions: The combination of docetaxel with lycopene led to improved PSA response rate and tolerability in patients with advanced castrate resistant prostate cancer. Docetaxel plus lycopene merits further research in this patient population. Clinical trial information: NCT01882985.

Prostate-specific antigen response among Black and non-Black patients with advanced prostate cancer treated with apalutamide in a urology setting.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 124-124
Author(s):  
Michael Durkin ◽  
Dominic Pilon ◽  
Carmine Rossi ◽  
Ibrahim Khilfeh ◽  
Frederic Kinkead ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prostate Specific Antigen ◽  
Clinical Data ◽  
Real World ◽  
Index Date ◽  
Specific Antigen ◽  
The United States ◽  
Median Baseline ◽  
Black Patients ◽  
Baseline Psa

124 Background: Apalutamide (APA) is approved to treat patients with non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic castration-sensitive prostate cancer (mCSPC) in the United States (US) but low enrollment of Black patients in clinical trials has led to limited clinical data about APA for this population. This study describes prostate-specific antigen (PSA) responses among Black and non-Black patients with nmCRPC or mCSPC treated with APA in a real-world community urology setting. Methods: Clinical data from 2/2018 to 3/2021 collected at 69 US urology practices were used to evaluate nmCRPC or mCSPC patients who received ≥1 APA prescription fill (index date). Baseline PSA was reported based with the most recent baseline PSA value and PSA doubling time (PSADT) in months (mo) was calculated in patients with at least 2 PSA tests before APA initiation. PSA response defined as the proportion of patients achieving either a reduction of 50% (PSA50) or 90% (PSA90) from baseline and was evaluated in patients with a PSA test result 8 weeks or later after initiating APA. Among patients with a response, the time from the index date to the response was also evaluated. Study results for Black and non-Black cohorts were summarized separately. Results: Data from 289 nmCRPC (19% Black) and 237 mCSPC (19% Black) patients were identified. Median baseline PSA, median baseline PSADT and post-index PSA responses are shown in Table. A PSA50 response was attained by numerically similar proportions of Black and non-Black patients with nmCRPC or mCSPC. A PSA90 response was observed in a numerically higher proportion of Black than non-Black nmCRPC patients. Median time to PSA50 and PSA90 was also similar between groups. Conclusions: This real-world study of nmCRPC and mCSPC patients demonstrates that PSA50 and PSA90 responses are achieved by high proportions of both Black and non-Black patients. Moreover, the PSA50 and PSA90 responses observed in this study are highly consistent with those observed in APA’s Phase 3 registrational trials for nmCRPC (SPARTAN)1 and for mCSPC (TITAN)2. References: 1Smith MR, et al. N Engl J Med. 2018;378:1408-1418. 2Chi KN, et al. N Engl J Med. 2019;381:13-24. Funding Source: Janssen Scientific Affairs, LLC.[Table: see text]

scholarly journals Real-World Outcomes of Advanced Soft Tissue Sarcoma Patients Treated with Pazopanib

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Fawaz A ◽  
◽  
Shim I ◽  
Tilley D ◽  
Kelaney MR ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Real World ◽  
Systemic Therapy ◽  
Kinase Inhibitor ◽  
Advanced Soft Tissue Sarcoma ◽  
Clinical Trial Setting ◽  
Trial Setting

Background: Pazopanib is an oral multitarget tyrosine kinase inhibitor that is currently approved for the treatment of select subtypes of advanced Soft Tissue Sarcoma (STS) in patients who have progressed on prior anthracyclinebased chemotherapy regimens. In this study, we examine data from multiple centers to assess the efficacy of pazopanib in practice outside of a clinical trial setting. Methods: A retrospective chart analysis was conducted for pre-treated, advanced soft tissue sarcoma patients who began treatment with pazopanib in Alberta, Canada and Cairo, Egypt (2012-2018). Results: In total, 39 predominantly male (56.4%) patients received pazopanib. The median age was 51, 67% of whom had an ECOG of one or less. The predominant sarcoma subtype was leiomyosarcoma (30.8%), and all patients had received at least one prior line of systemic therapy. Thirtytwo of the 39 patients (82%) were initially given the full dose of 800mg with a median time on treatment of 116 days. Seven of the 39 (18%) patients required a dose reduction while on treatment. A majority (94.9%) of patients ultimately discontinued pazopanib treatment for reasons including death (21.6%), disease progression (62.2%), and toxicity (16.4%). The median progression-free and overall survival for these patients was 4.1 months (95%CI, 3.6-4.5) and 8.4 months (95% CI, 4.3-12.5), respectively. Conclusion: Pazopanib is an efficient and generally well-tolerated oral systemic therapy for the treatment of advanced, pre-treated, non-adipocytic soft tissue sarcoma. These results show the efficacy of pazoponib outside of a clinical trial setting.

scholarly journals Phase II trial of acai juice product in biochemically recurrent prostate cancer.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 230-230 ◽  
Author(s):  
Elizabeth Riley Kessler ◽  
Lih-Jen Su ◽  
Xiaoping Yang ◽  
Xian Lu ◽  
Diana Morales ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Phase Ii ◽  
Doubling Time ◽  
Recurrent Prostate Cancer ◽  
Psa Doubling Time ◽  
Psa Response ◽  
Psa Velocity ◽  
The One ◽  
Baseline Psa

230 Background: There are conflicting data as to the benefit of treating patients with biochemically recurrent prostate cancer (PCa). Plant derivatives, called “nutraceuticals” such as grape seed extract or milk thistle, have been studied as therapies for PCa based on their purported anti-inflammatory and anti-oxidant properties and low toxicities. Acai is a fruit rich in bioflavinoids shown to induce apoptosis in preclinical studies of PCa, leukemia and esophageal cancer. Anecdotal experience of two patients with falling prostate specific antigen (PSA) values while consuming acai juice prompted us to evaluate its efficacy in a clinical trial. Methods: This was a phase II Simon two-stage open-label single-arm single-institution study of the efficacy of Acai Juice Product in asymptomatic PCa patients with a rising PSA. Eligibility included lack of current hormone therapy, hormone sensitivity, and a PSA doubling time of >4 weeks. Patients consumed 2 oz of Acai Juice Product twice daily for 30 weeks, with a primary endpoint of PSA response. Secondary endpoints included PSA doubling time, PSA velocity, and duration of PSA response. Progression was defined as a rise of 25% from baseline PSA with absolute rise of 2ng/dL. Results: 21 patients were enrolled in the first stage of the trial. Median baseline PSA was 2.74 (range 0.38-36.88). Eighteen patients have completed therapy with 1 PSA response. In the one responder, the patient entered with a doubling time of 4 months and a PSA of 12.57, which was 2.15 at 36 weeks suggesting a prolonged and continued response. PSA either decreased or doubling time prolonged from baseline in 18 patients. PSA velocity was a negative rate of change per month in 4 patients. Conclusions: Acai juice did not produce enough PSA responses in this patient population to proceed beyond the first stage of this trial. However, PSA doubling time did slow in 85.7% of patients, and the one observed PSA response was sustained over at least 36 weeks at the time of data cutoff. Thus, we will analyze potential cellular signals through an M30 Apotosense ELISA assay and Human Cytokine 10-plex panel on patient samples with data available for presentation at the meeting. Clinical trial information: NCT01521949.

Phase II screening study to assess the combination of a LHRH analogue, dexamethasone and a somatostatin analogue versus a LHRH analogue with dexamethasone in hormone refractory prostate cancer patients

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4565-4565 ◽  
Author(s):  
F. Silva ◽  
F. M. Calais Da Silva ◽  
F. Gonçalves ◽  
T. Oliver
Keyword(s):  
Prostate Cancer ◽  
Median Time ◽  
Median Duration ◽  
Prostatic Carcinoma ◽  
Response Rate ◽  
Hormone Refractory Prostate Cancer ◽  
Treatment Regimens ◽  
Psa Response ◽  
Psa Progression ◽  
Hormone Refractory

4565 Background: Hormonal changes and the possible resulting imbalance between androgen and estrogen levels in elderly men may play an important role in prostatic pathogenesis. Androgen suppression can induce regression of prostatic carcinoma. Ample laboratory and clinical research have contributed to evidence that a direct link exists between prostatic cell growth, prostatic carcinoma cell growth and hormones, mainly testicular androgens. As far as prostatic cancer is concerned, we know that SMS blocks GH, PRL, tissular growth factors (TGF) and that it has a direct antiproliferative growth cellular growth effect. The simultaneous administration of depot forms of SMS and LHRH analogues induced the greatest decrease in tumor growth. Methods: A randomized Phase II trial was carried out in M0 (PSA ≥ 20 ng/ml) and M1 patients with hormone refractory prostate cancer to simultaneously screen decapeptyl and dexamethasone, both with and without somatulin (120 mg every 4 weeks), with respect to PSA response rate, time to PSA progression, duration of survival and toxicity. Results: 72 patients with a median time PSA of 77 ng/ml were randomized by 3 institutions, 35 to decapeptyl, dexamethasone and somatulin (DDS) and 37 to decapeptyl and dexamethasone (DD). 21 of 33 (64%) patients on DDS and 21 of 32 on DD (66%) had a PSA response (a decrease of at least 50 % as compared to baseline). The median duration of PSA response was 6.6 months on DDS and 3.4 months on DD. Overall, the median time to PSA progression was 5.8 months on DDS and 1.8 months on DD. The median duration of survival has not yet been reached. Both treatment regimens were well tolerated. The most frequent toxicities on DDS and DD were hot flushes (27%, 10%), gastrointestinal (18%, 20%), and skin complaints (12%, 10%). Conclusions: Both treatment regimens are active and safe in the treatment of hormone refractory prostate cancer. Although the PSA response rate is about 65%, the median duration of response and median time to progression were longer in the somatulin arm; so, the data suggest a possible advantage of DDS with respect to both the duration of the PSA response and the time to PSA progression. Further follow-up is required to assess survival. No significant financial relationships to disclose.

Antitumor activity of abiraterone, enzalutamide, and docetaxel following treatment with diethystilbestrol in castration-resistant prostate cancer.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. e581-e581
Author(s):  
Sandra Assoun ◽  
Luca Campedel ◽  
Morgan Roupret ◽  
Christophe Vaessen ◽  
Jerome Parra ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Antitumor Activity ◽  
Median Time ◽  
Specific Antigen ◽  
Cross Resistance ◽  
Castration Resistant Prostate Cancer ◽  
Clinicopathologic Characteristics ◽  
Castration Resistant ◽  
Psa Response ◽  
Psa Progression

e581 Background: Docetaxel and Next-Generation Anti-Androgens (NGAA) including abiraterone and enzalutamide represent the standard of treatment for patients with castration-resistant prostate cancer (CRPC). Treatment sequencing of these agents is a challenge. Recent studies identified cross-resistances between hormonal therapies and taxanes, as well as between different NGAA. In aiming to elucidate whether synthetic oestrogen diethylstilbestrol (DES) therapy impacts the efficacy of later-line treatments or not, we evaluated the antitumor activity of NGAA and docetaxel following DES therapy in CRPC patients. Methods: All patients with CRPC treated at Pitié-Salpêtrière hospital in first-line setting with DES from September 1995 to July 2016 were retrospectively identified. We evaluated further activities of abiraterone, enzalutamide and docetaxel in those patients after DES therapy, using Prostate Cancer Working Group 3 criteria. Clinicopathologic characteristics, including age, performans status, metastatic sites at diagnosis and treatments initiation, and data survival were also assessed. Results: Twenty-three patients with CRPC were initially treated with DES with a median time to prostate-specific antigen (PSA) progression of 9.7 months (range, 4.7-20.3). Thirteen patients(56.5%) received abiraterone or enzalutamide before docetaxel and 21 patients (91.3%) after. Median age at first NGAA initiation was 79 years) range, 55-91). Only one patient (7.7%) achieved a PSA decline before docetaxel and two out of 18 evaluable patients (11.1%) after docetaxel. Median time to PSA progression and overall survival with a NGAA treatment were respectively 2.8 (range, 2.0-4.1) and 16.5 months(range, 4.3-31.0). Fifty percent of patients showed a PSA response with docetaxel. No clinical factors were found to be significantly associated with PSA response to NGAA treatment, nor to docetaxel. Conclusions: The activity of NGAA appears markedly limited after a DES therapy, regardless of the PSA response to docetaxel. These data suggest the likelihood of a cross-resistance mechanism between DES and NGAA, without no impact on taxanes pathways.

PSA progression compared to radiographic or clinical progression in metastatic castration-resistant prostate cancer patients treated with enzalutamide.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 105-105
Author(s):  
Shruti U. Gandhy ◽  
Fatima Karzai ◽  
Jennifer L. Marte ◽  
Marijo Bilusic ◽  
Sheri McMahon ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Median Time ◽  
Castration Resistant Prostate Cancer ◽  
Clinical Progression ◽  
Open Label ◽  
Therapeutic Cancer Vaccine ◽  
Castration Resistant ◽  
Psa Progression ◽  
Near Term

105 Background: Enzalutamideis ahighly effective treatment in patients with metastatic castration resistant prostate cancer (mCRPC). Although Prostate Cancer Working Group Guidelines (PCWG) recommend continuing treatment until radiographic progression of disease (rPD) or clinical progression (cPD), many patients discontinue therapy for rising PSA alone. Methods: We conducted an open label, randomized phase 2 clinical trial in mCRPC patients (on testosterone suppression therapy) previously untreated with docetaxel, abiraterone, or enzalutamide, comparing enzalutamide alone or in combination with PROSTVAC, a therapeutic cancer vaccine designed to induce an anti-tumor immune response. The study discontinued accrual after a planned interim analysis indicated no difference in progression between the two arms. Patients were followed beyond PSA progression (first of three confirmed PSA rises, evaluated monthly) until rPD per PCWG (scans done every 3 months per protocol). Results: A total of 57 patients were enrolled with a median follow up time of 55.4 months. Of those, 47 (82%) patients were Caucasian and seven (12%) patients were African American. The median age of patients on enrollment was 67.2 years. 49/57 (86%) patients had PSA progression and the median time to first PSA rise for all 57 patients combined was 6.4 months (95% CI: 3.7-11.0 months) after starting enzalutamide. 38/57 (67%) patients experienced progressive disease (majority with rPD and 1/38 (3%) with cPD), with the median time to progression for all 57 patients of 23.3 months (95% CI: 16.1-27.8 months). Conclusions: Consistent with PCWG recommendations, these data suggest that a rising PSA may not be a warning of near-term clinically significant disease progression in mCRPC patients given the nearly 17-month difference between the first rise in PSA and ultimate rPD or cPD seen in this analysis. These data highlight the need to continue to educate patients and providers on PCWG criteria for progression, which were also used in original trials that led to the FDA approval of enzalutamide, so as not to substantially limit the potential efficacy of mCRPC therapies such as enzalutamide. Clinical trial information: NCT01867333.

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