Effectiveness and Distribution of Testosterone Levels within First Year of Androgen Deprivation Therapy in a Real-World Setting: Results from the Non-Interventional German Cohort LEAN Study

Background: Observational studies generate information on real-world therapy and complement data from prospective randomized trials. LEAN is an open-label, non-interventional, multi-centre, German cohort study on leuprorelin in routine clinical practice. Objectives: To extend knowledge on the use, effectiveness, and tolerability of HEXAL/Sandoz leuprorelin (in this article, the term Leuprone® HEXAL® covers Leuprorelin Sandoz® as well) solid implant in patients with prostate cancer (PCa) in a real-world setting. Methods: 959 PCa patients scheduled for androgen deprivation therapy (ADT) received leuprorelin acetate implant. Metabolism, serum prostate-specific antigen (PSA), and testosterone data, if available, were collected at baseline and follow-up visits for ≥12 months. Results: Of 694 patients in the modified full analysis set, 26.4% received GnRH analogues ≤6 months before enrolment. Fifty-one percent of patients were treated for locally advanced or metastatic PCa. In 19.6% of patients, ADT was used in neoadjuvant or adjuvant settings and in 28.5% with rising PSA after definite therapy. Testosterone levels <0.5 ng/mL were achieved in >90% of patients. Safety profile was in line with the summary of product characteristics. Therapy was well tolerated, with patient-triggered therapy discontinuation in 3.6%. Conclusions: This interim analysis confirmed previous efficacy findings for leuprorelin implant in a real-world setting. This contemporary cohort showed a shift in the use of ADT to non-metastatic PCa stages.

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Long- versus short-term androgen deprivation therapy with high-dose radiotherapy for biochemical failure after radical prostatectomy: a randomized controlled trial

Future Oncology ◽

10.2217/fon-2020-0390 ◽

2020 ◽

Vol 16 (27) ◽

pp. 2035-2044

Author(s):

Charlien Berghen ◽

Steven Joniau ◽

Annouschka Laenen ◽

Gaetan Devos ◽

Kato Rans ◽

...

Keyword(s):

Radical Prostatectomy ◽

Androgen Deprivation Therapy ◽

Controlled Trial ◽

Locally Advanced ◽

Lymph Node Involvement ◽

Androgen Deprivation ◽

High Dose ◽

Open Label ◽

Clinical Trial Registration ◽

Substantial Risk

Radical prostatectomy is a well-established treatment option in the management of localized and locally advanced prostate cancer. An extended lymphadenectomy is performed in case of substantial risk for lymph node involvement. When biochemical recurrence (BCR) occurs, salvage radiotherapy (SRT) is performed. The benefit in terms of BCR-free survival (FS) and metastasis-FS by adding 6 months of androgen deprivation therapy (ADT) compared with SRT only has already been established. Retrospective evidence suggests that a longer schedule of ADT may be more beneficial compared with 6 months. This multicenter open-label randomized trial will include patients who need SRT after experiencing BCR post-radical prostatectomy with lymphadenectomy and pN0-status. Patients will be randomized for ADT duration (6 vs 24 months). Primary end point is distant metastasis-FS. Clinical Trial Registration: NCT04242017 ( ClinicalTrials.gov )

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Androgen Deprivation Therapy in Prostate Cancer: Looking Beyond Prostate-specific Antigen and Testosterone Levels

European Urology ◽

10.1016/j.eururo.2014.08.033 ◽

2015 ◽

Vol 67 (5) ◽

pp. 837-838 ◽

Cited By ~ 3

Author(s):

Fred Saad

Keyword(s):

Prostate Cancer ◽

Prostate Specific Antigen ◽

Androgen Deprivation Therapy ◽

Specific Antigen ◽

Androgen Deprivation ◽

Testosterone Levels

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Final Report of the Intergroup Randomized Study of Combined Androgen-Deprivation Therapy Plus Radiotherapy Versus Androgen-Deprivation Therapy Alone in Locally Advanced Prostate Cancer

Journal of Clinical Oncology ◽

10.1200/jco.2014.57.7510 ◽

2015 ◽

Vol 33 (19) ◽

pp. 2143-2150 ◽

Cited By ~ 147

Author(s):

Malcolm D. Mason ◽

Wendy R. Parulekar ◽

Matthew R. Sydes ◽

Michael Brundage ◽

Peter Kirkbride ◽

...

Keyword(s):

Prostate Cancer ◽

Overall Survival ◽

Androgen Deprivation Therapy ◽

Advanced Prostate Cancer ◽

Locally Advanced ◽

Specific Antigen ◽

Androgen Deprivation ◽

Final Report ◽

Locally Advanced Prostate Cancer

Purpose We have previously reported that radiotherapy (RT) added to androgen-deprivation therapy (ADT) improves survival in men with locally advanced prostate cancer. Here, we report the prespecified final analysis of this randomized trial. Patients and Methods NCIC Clinical Trials Group PR.3/Medical Research Council PR07/Intergroup T94-0110 was a randomized controlled trial of patients with locally advanced prostate cancer. Patients with T3-4, N0/Nx, M0 prostate cancer or T1-2 disease with either prostate-specific antigen (PSA) of more than 40 μg/L or PSA of 20 to 40 μg/L plus Gleason score of 8 to 10 were randomly assigned to lifelong ADT alone or to ADT+RT. The RT dose was 64 to 69 Gy in 35 to 39 fractions to the prostate and pelvis or prostate alone. Overall survival was compared using a log-rank test stratified for prespecified variables. Results One thousand two hundred five patients were randomly assigned between 1995 and 2005, 602 to ADT alone and 603 to ADT+RT. At a median follow-up time of 8 years, 465 patients had died, including 199 patients from prostate cancer. Overall survival was significantly improved in the patients allocated to ADT+RT (hazard ratio [HR], 0.70; 95% CI, 0.57 to 0.85; P < .001). Deaths from prostate cancer were significantly reduced by the addition of RT to ADT (HR, 0.46; 95% CI, 0.34 to 0.61; P < .001). Patients on ADT+RT reported a higher frequency of adverse events related to bowel toxicity, but only two of 589 patients had grade 3 or greater diarrhea at 24 months after RT. Conclusion This analysis demonstrates that the previously reported benefit in survival is maintained at a median follow-up of 8 years and firmly establishes the role of RT in the treatment of men with locally advanced prostate cancer.

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Phase II study of biweekly docetaxel plus androgen-deprivation therapy (ADT) in patients with previously-untreated, metastatic, prostatic adenocarcinoma.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e17580 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e17580-e17580

Author(s):

Seonggyu Byeon ◽

Hana Kim ◽

Hongsik Kim ◽

Hwang Gyun Jeon ◽

Seong Soo Jeon ◽

...

Keyword(s):

Prostate Cancer ◽

Androgen Deprivation Therapy ◽

Phase Ii ◽

Specific Antigen ◽

Androgen Deprivation ◽

Castration Resistant Prostate Cancer ◽

Open Label ◽

Free Survival ◽

Psa Response ◽

One Year

e17580 Background: To evaluate the efficacy and safety of biweekly docetaxel (bD) plus androgen-deprivation therapy (ADT) in metastatic castration-naïve prostate cancer (mCNPC). Methods: This was an open-label, prospective, single-arm phase II trial. 42 patients with mCNPC were treated with docetaxel 40 mg/m2 every two weeks plus ADT. The primary end point was one year castration-resistant prostate cancer (CRPC)-free survival rate and the secondary end points were prostate-specific antigen (PSA) response, time to CRPC and safety. Results: Most patients (87.5%) had Gleason score 8 or more. The median value of PSA at initial treatment was 66.9 ng/ml (range 0.04 to 2339). After bD plus ADT, 39 patients (92.9%) had a PSA response (reduced PSA level 50% or more). The time to CRPC (one-year CRPC free survival 73.6%) and the duration of PSA response (18 months response 80.4%) did not reach the median. The bD plus ADT regimen was well-tolerated. The most common adverse events included neutropenia, nail changes and diarrhea. Conclusions: bD plus ADT treatment demonstrated favorable treatment outcomes with tolerability. Clinical trial information: NCT03061643 .

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Use and outcomes in men with metastatic castration-sensitive prostate cancer (mCSPC) treated with docetaxel in addition to androgen deprivation therapy (ADT): Analysis of real-world data in the United States (US).

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e19322 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e19322-e19322

Author(s):

Neeraj Agarwal ◽

Suneel Mundle ◽

Lindsay Dearden ◽

Ravi C. Potluri ◽

Sandhya Nair ◽

...

Keyword(s):

Prostate Cancer ◽

Androgen Deprivation Therapy ◽

Real World ◽

De Novo ◽

Specific Antigen ◽

The United States ◽

Androgen Deprivation ◽

Castration Resistant Prostate Cancer ◽

The Real ◽

The Us

e19322 Background: mCSPC patients treated with docetaxel + androgen deprivation therapy (D+ADT) demonstrate increased overall survival (OS)1,2. However, limited real-world outcome data is available for such patients. This study assesses the real-world use and outcomes with D+ADT in mCSPC in the US. Methods: Adult (≥18 years old) men with mCSPC (defined as men with metastasis at index diagnosis of prostate cancer [de novo] or those who progressed to mCSPC after prior diagnosis of localized disease) were retrospectively identified from the Optum (2007–2018) and SEER Medicare (2007–2016) databases. Men diagnosed with mCSPC in or after 2014 with exposure to docetaxel and no brain metastasis were included for analysis. Patients were characterized based on age; baseline prostate specific antigen (PSA) level; administration of ADT; prior radiotherapy (RT); prior radical prostatectomy (RP); presence of visceral disease, bone or bone + visceral metastases; and treatment duration of docetaxel. OS and time to metastatic castration-resistant prostate cancer (mCRPC) were measured. Results: Among 4959 men identified with mCSPC during or after 2014, 192 (3.8%) received D+ADT ± Bicalutamide as first line systemic therapy. Baseline characteristics are presented in the Table below. Mean ± SD duration of docetaxel exposure was 115 ± 84.2 days (median 118 days). Median OS among these men was 30.5 (28.1, 36.7) months and median time to mCRPC was 18.3 (14.5, 24.6) months. Only 9% of men received docetaxel for ≥6 cycles (180 days); median OS in these men was NR (19.1- NR) with 74% surviving at 2 years compared to 65% surviving at 2 years in those with docetaxel duration <6 cycles. Conclusions: Use of docetaxel in the real-world mCSPC patient population in the US is limited. Majority of men received less than the recommended dose of 6 cycles. OS with D+ADT in real-world patients with mCSPC appears to be lower than the OS reported in published trials. References:1) Sweeney CJ, et al. N Engl J Med. 2015;373:737–46. 2) James ND, et al. Lancet. 2016;387:1163–77. Funding: Janssen Research & Development, LLC. [Table: see text]

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