scholarly journals Baseline and follow-up association of the MAX-PC in Men with newly diagnosed prostate cancer

2014 ◽  
Vol 24 (4) ◽  
pp. 451-457 ◽  
Author(s):  
Andrea M. Tavlarides ◽  
Steven C. Ames ◽  
David D. Thiel ◽  
Nancy N. Diehl ◽  
Alexander S. Parker
Keyword(s):  
Prostate Cancer ◽  
Newly Diagnosed

Five year follow up of a phase II study of cytotoxic immunotherapy combined with radiation in newly diagnosed prostate cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4635-4635 ◽  
Author(s):  
L. K. Aguilar ◽  
B. Teh ◽  
W. Mai ◽  
J. Caillouet ◽  
G. Ayala ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Controlled Trial ◽  
Pathologic Complete Response ◽  
Low Risk ◽  
Control Group ◽  
Newly Diagnosed ◽  
Kinase Gene ◽  
Cell Immunity

4635 Background: In the U.S. there are about 70,000 annual prostate cancer recurrences. The purpose of this study is to evaluate a product to decrease incidence of recurrence. This study is based on objective clinical responses in Phase I studies with AdV-tk (ProstAtak™, Advantagene, Inc) as monotherapy in recurrent disease and preclinical data demonstrating synergy between AdV-tk and radiation. AdV-tk is an adenoviral vector expressing the herpes thymidine kinase gene delivered to the prostate via TRUS-guided injection followed by 14 days of oral prodrug. The mechanisms of function involve direct tumor cytotoxicity, local elicitation of danger signals, recruitment and activation of antigen presenting cells and stimulation of systemic anti-tumor T-cell immunity. Method: AdV-tk was evaluated in combination with radiation in 66 newly diagnosed patients: 33 low risk (Arm A, PSA <10, Gleason <7, and T1c-T2a) and 33 intermediate-high risk (Arm B, PSA ≥10, Gleason ≥7, or T2b-T3). Arm A received two treatments with AdV-tk, immediately before and 14 days into radiation. Arm B received an additional treatment at initiation of androgen deprivation therapy. Results: Two surrogate and one definitive end-point were evaluated. Frequency of patients in Arm A with PSA nadir ≤0.2 ng/ml was 71% vs 56% in a control group of concurrent patients without AdV-tk. The two-year pathologic complete response (pCR) rate by sextant biopsy was 90% in Arm A and 94% in Arm B, compared to an expected range of 70–73%. Freedom from failure (FFF) after 60 month median follow up is 100% for Arm A and 90% for Arm B (95% for intermediate, 75% for high risk) vs best reported results of 79–90% for low risk and 48–79% for intermediate-high risk patients. The three failures in Arm B occurred within months after treatment leading to a Kaplan-Meier curve that plateaus at 90% beyond year 3. This is notably different than previous reports in which the curves continue to drop beyond year 5. Conclusion: These results suggest that AdV-tk combined with radiation therapy may significantly reduce the recurrence rate in patients with prostate cancer, particularly in patients with intermediate-high risk disease. A randomized controlled trial is warranted. [Table: see text]

Disease-specific survival outcomes in lymph node–positive patients with prostate cancer treated with radiotherapy.

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 182-182 ◽  
Author(s):  
G. Crehange ◽  
V. K. Weinberg ◽  
A. Izaguirre ◽  
C. C. Hsu ◽  
I. J. Hsu ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Disease Free Survival ◽  
External Beam Radiation ◽  
Survival Outcomes ◽  
Primary Therapy ◽  
Newly Diagnosed ◽  
Beam Radiation ◽  
Androgen Ablation ◽  
Disease Free

182 Background: Involvement of regional lymph nodes (LN+) at the time of prostate cancer (PCa) diagnosis is widely regarded as an adverse prognostic factor associated with poor outcome. No commonly utilized treatment, composed of any combination of androgen ablation, surgery and radiation, has proven to be superior for survival. This study will evaluate the clinical survival outcomes of patients (pts) with newly diagnosed LN+ PCa at the University of California San Francisco (UCSF). Methods: All newly diagnosed LN+ PCa pts treated with External Beam Radiation Therapy (EBRT) as primary therapy or after surgery, each with and without androgen ablation between 1987 and 2009 were included. All pts had confirmed pathologic or radiologic LN+ whereas none had evidence of metastases on the work up. Cause Specific Survival (CSS), Disease Free survival (DFS) and biochemical control were measured from the start of treatment. PSA failure was determined by the Phoenix definition after EBRT and by a confirmed PSA >1 ng/mL following RP+EBRT. Results: A retrospective analysis identified 91 pts with LN+ at the time of diagnosis (75.8% high risk pts) with disease follow-up. Thirty-four (37%) were managed with exclusive EBRT alone (eRT), 18 pts (20%) with a combination of radical prostatectomy (RP) and adjuvant EBRT (RP+aRT) and 39 pts (43%) were treated with a combination of RP + salvage RT (RP+sRT). Overall 78% of patients also received hormone therapy (HT): 74.0% with eRT, 89% with RP+aRT and 79% with RP+sRT. The 10 years CSS estimates was 89% for eRT, 0% after RP+aRT and 88% after RP+sRT. The 10 years DFS estimates was 33% for eRT, 0% after RP+aRT and 75% after RP+sRT. Among pts remaining disease free the median follow-up is 38 mos for eRT, 26 mos for RP+aRT and 64 mos for RP+sRT. The last PSA for these patients was <0.1 for 85% of all patients which included 47% following eRT, 100% after RP+aRT and 97% after RP+sRT. There were 7 deaths due to PCa occurring between 5 and 73 mos from the start of EBRT. Conclusions: The results of the current analysis indicate that some pts with LN+ from PCa have prolonged disease free outcomes; and for these men, aggressive treatment may be appropriate. No significant financial relationships to disclose.

Prostate-directed radiation therapy and overall survival for men with M1a prostate cancer.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 101-101
Author(s):  
David Dewei Yang ◽  
Santino Butler ◽  
Vinayak Muralidhar ◽  
Brandon Arvin Virgil Mahal ◽  
Neil E. Martin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Radiation Therapy ◽  
Confidence Interval ◽  
Androgen Deprivation Therapy ◽  
Androgen Deprivation ◽  
Gleason Grade ◽  
Newly Diagnosed ◽  
Metastatic Burden

101 Background: A recent randomized controlled trial demonstrated that radiation therapy to the prostate improves overall survival for men with newly diagnosed metastatic prostate cancer with a low metastatic burden. Most patients in this trial had bony metastases (stage M1b). The benefit of prostate-directed radiation therapy for men with metastases limited to non-regional lymph nodes (stage M1a) is unknown. We investigated the association between prostate-directed radiation therapy and overall survival for men with M1a prostate cancer. Methods: We identified 2,079 men from the National Cancer Database who were newly diagnosed with M1a prostate adenocarcinoma from 2004 through 2014 and had data on the use of androgen deprivation therapy, chemotherapy, and radiation therapy. Median follow-up was estimated using the reverse Kaplan-Meier method. The association between radiation therapy to the prostate and overall survival was examined using multivariable Cox proportional hazards regression analysis. Results: Overall, 12.7% (264) of patients received radiation therapy to the prostate. Median follow-up was 4.6 years (95% confidence interval 4.3-4.8 years). On multivariable analysis, when accounting for the use of androgen deprivation therapy and chemotherapy, Gleason grade group, clinical tumor and nodal stage, and prostate-specific antigen level at diagnosis, the use of radiation therapy to the prostate was associated with a significant improvement in overall survival (adjusted hazard ratio 0.60, 95% confidence interval 0.49-0.74, P<0.001). Adjusted median overall survival was 3.3 years for patients who did not receive radiation therapy to the prostate compared to 5.5 years for patients who did. Conclusions: Similar to newly diagnosed M1b prostate cancer with a low metastatic burden, patients with M1a prostate cancer may also derive a significant overall survival benefit from receiving radiation therapy to the primary prostate tumor. The use of prostate-directed radiation therapy for M1a patients should be further investigated.

Trends in use of intravenous bisphosphonates in patients with prostate cancer and newly diagnosed metastases to bone in two large U.S. integrated health systems.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 192-192
Author(s):  
Lois Lamerato ◽  
Andrew Glass ◽  
Kathryn E. Richert-Boe ◽  
John Edelsberg ◽  
Greg G. Wolff ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Health Systems ◽  
Pathologic Fracture ◽  
Median Number ◽  
Cord Compression ◽  
Newly Diagnosed ◽  
Integrated Health ◽  
Skeletal Complications ◽  
Intravenous Bisphosphonates

192 Background: Bone is a common site of metastatic involvement in patients (pts) with prostate cancer (PC). Bony metastases (mets) are associated with skeletal complications, which can cause significant morbidity and mortality. Intravenous bisphosphonates (IV BPs) have been proven to reduce the incidence and onset of skeletal complications. Patterns of use of IV BPs in clinical practice in pts with bone mets due to PC are largely unknown. Methods: Using the tumor registries and electronic data stores at two large US integrated health systems that serve a total of approximately 1.3 million persons, we retrospectively identified all pts aged ≥18 yrs with primary PC and newly diagnosed bone mets between 1/1/95 and 12/31/09. Information on all administrations of IV BPs between date of diagnosis of bone mets and death, loss to follow-up, or end of study was extracted from administrative data stores and electronic medical records, which also were reviewed by trained medical abstractors for evidence of skeletal-related events (SREs) (spinal cord compression, pathologic fracture, surgery to bone, radiation to bone). Results: We identified a total of 461 pts with primary PC and newly diagnosed bone mets. Mean (SD) age was 72.8 yrs (10.7 yrs); 75% were Caucasian, and 21% were African-American. Median duration of follow-up after diagnosis of bone mets was 1.3 yrs. One-fifth (20.2%) of study subjects received IV BPs (92% zoledronic acid, 8% pamidronate) during follow-up--10.8% prior to, and 9.3% after, first on-study SRE. Median time from diagnosis of bone mets to first administration of IV BPs was 1.7 yrs, and the median number of administrations was 3. The percentage of study subjects receiving IV BPs increased steadily over the 15-yr study period--from 7.5% among those newly diagnosed with bone mets in 1995-1999, to 19.8% among those newly diagnosed with bone mets in 2000-2004, to 27.5% among those newly diagnosed with bone mets in 2005-2009. Conclusions: Despite a high risk of SREs in pts with PC and bone mets, most such pts still do not receive IV BPs.

Changes in conditional net survival and dynamic prognostic factors in patients with newly diagnosed metastatic prostate cancer.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 247-247
Author(s):  
Shintaro Narita ◽  
Kyoko Nomura ◽  
Shingo Hatakeyama ◽  
Masahiro Takahashi ◽  
Toshihiko Sakurai ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prognostic Factors ◽  
Prognostic Factor ◽  
Clinical Decision Making ◽  
Cox Regression ◽  
Clinical Decision ◽  
Newly Diagnosed ◽  
Cancer Specific Survival ◽  
Net Survival

247 Background: The treatment strategy for patients with newly diagnosed metastatic hormone naïve prostate cancer (mHNPC) has changed in recent years. Thus, an accurate assessment of prognosis is critical. Conditional net survival provides the more appropriate method of estimating survival from cancer. The purpose of this study was to identify predictive factors associated with conditional net survival in patients with mHNPC initially treated with androgen deprivation therapy (ADT). Methods: The medical records of 605 consecutive patients with mHNPC who initially received ADT were retrospectively reviewed. The Pohar Perme estimator was used to calculate conditional net cancer-specific survival (CSS) and overall survival (OS) for up to five years subsequent to the diagnosis. Using multiple imputation, proportional hazard ratios for conditional CSS and OS were calculated with adjusted Cox regression models. Results: During follow-up (median, 2.95 years), 208 patients died, 169 from progressive prostate cancer. At baseline, the 5-year CSS and OS rates were 65.5% and 58.2%, respectively. The overall conditional 5-yearnet OS rate at baseline was 0.582, and the overall conditional 5-year net OS rates for patients who survived for1, 2, 3, 4, and 5 years were 0.566 (−0.16), 0.615 (+3.3), 0.550 (−0.32), 0.702 (+1.2), and 0.811 (+2.29), respectively. Conditional 5-year net CSS and OS survival gradually increased for all the patients. In patients given a 5-year survivorship, the conditional 5-year net CSS and OS rates improved to 0.906 and 0.811, respectively. Only the extent of disease score (EOD) ≥2 remained a prognostic factor for CSS and OS up to 5 years; as survival time increased, other variables were no longer independent prognostic factors. Conclusions: The conditional 5-year net CSS and OS in patients with mHNPC gradually increased; thus, the risk of mortality decreased with increasing survival. The patient’s risk profile changed over time. EOD remained an independent prognostic factor for CSS and OS after 5-year follow-up. Conditional net survival can play a role in clinical decision-making, providing intriguing information for cancer survivors.

A phase II study combining ipilimumab and degarelix with or without radical prostatectomy (RP) in men with newly diagnosed metastatic noncastration prostate cancer (mNCPC) or biochemically recurrent (BR) NCPC.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 203-203 ◽  
Author(s):  
Karen A. Autio ◽  
James Andrew Eastham ◽  
Daniel Costin Danila ◽  
Susan F. Slovin ◽  
Michael J. Morris ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Doubling Time ◽  
Phase Ii Study ◽  
Multimodality Treatment ◽  
Newly Diagnosed ◽  
Complete Elimination ◽  
Modality Approach ◽  
Clinical Trial Information

203 Background: Androgen deprivation therapy (ADT) does not completely eliminate disease in mNCPC or BRPC. We explored a multimodality treatment (tx) approach combining ADT with ipilimumab (ipi) with the aim of achieving no evidence of disease or complete elimination of disease, given the potential for cure seen with immunotherapy. Methods: Cohort A (Coh A) enrolled men with ≤ 10 bone metastases treated with induction of degarelix (deg) and ipi prior to RP and subsequent ipi q3 weeks x 3 and 8 months (mos) total of deg. Cohort B (Coh B) opened later and enrolled men with BRNCPC after RP with a doubling time ≤ 12 mos, and received ipi q3 weeks x 4 and 8 mos of deg. The primary endpoint was an undetectable PSA (<0.05) at 12 and 20 mos with non-castrate testosterone. Results: 16 pts (7 Coh A; 9 Coh B) were treated. No Coh A pts experienced immune related toxicities (irAE) that delayed surgery. 4/7 (57%) Coh A pts came off study for irAE, 1 (14%) for insurance reasons, and 2 (29%) completed all protocol requirements. In Coh B 6/9 (67%) pts have completed tx and entered follow-up. Conclusions: A combined modality approach with ipi 10mg/kg, ADT, and RP in mNCPC was associated with limiting toxicities, however 3mg/kg was better tolerated and more feasible in a BRNCPC cohort. One pt in Coh A (14%) had an undetectable PSA with testosterone recovery while evaluation of efficacy for Coh B is ongoing. The role for RP and other immunotherapeutic approaches in NCPC remain viable interests to the field. Clinical trial information: NCT02020070. [Table: see text]

scholarly journals Testosterone Replacement Therapy and the Risk of Prostate Cancer in Men With Late-Onset Hypogonadism

2019 ◽  
Vol 188 (9) ◽  
pp. 1666-1673 ◽  
Author(s):  
Christina Santella ◽  
Christel Renoux ◽  
Hui Yin ◽  
Oriana H Y Yu ◽  
Laurent Azoulay
Keyword(s):  
Prostate Cancer ◽  
Replacement Therapy ◽  
Late Onset ◽  
Testosterone Replacement ◽  
Testosterone Replacement Therapy ◽  
Newly Diagnosed ◽  
Increased Risk ◽  
Late Onset Hypogonadism ◽  
The Impact

Abstract The association between the use of testosterone replacement therapy (TRT) and prostate cancer remains uncertain. Thus, we investigated whether TRT is associated with an increased risk of prostate cancer in men with late-onset hypogonadism. We used the UK Clinical Practice Research Datalink to assemble a cohort of 12,779 men who were newly diagnosed with hypogonadism between January 1, 1995, and August 31, 2016, with follow-up until August 31, 2017. Exposure to TRT was treated as a time-varying variable and lagged by 1 year to account for cancer latency, with nonuse as the reference category. During 58,224 person-years of follow-up, a total of 215 patients were newly diagnosed with prostate cancer, generating an incidence rate of 3.7 per 1,000 person-years. In time-dependent Cox proportional hazards models, use of TRT was not associated with an overall increased risk of prostate cancer (hazard ratio = 0.97; 95% confidence interval: 0.71, 1.32) compared with nonuse. Results remained consistent in secondary and sensitivity analyses, as well as in a propensity score–matched cohort analysis that further assessed the impact of residual confounding. Overall, the use of TRT was not associated with an increased risk of prostate cancer in men with late-onset hypogonadism.

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