Abiraterone acetate plus LHRH therapy versus abiraterone acetate while sparing LHRH therapy in patients with progressive, metastatic and chemotherapy-naïve, castration-resistant prostate cancer (SPARE): study protocol for a randomized controlled trial

Ohlmann, Carsten-Henning; Jäschke, Michelle; Jaehnig, Peter; Krege, Susane; Gschwend, Jürgen E.; Rexer, H.; Stöckle, Michael

doi:10.1186/s13063-017-2195-x

Cited by 12 publications

(7 citation statements)

References 20 publications

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“…Of note, there is a study currently underway attempting to evaluate the need to continue medical castration in men being treated with abiraterone in Germany (the SPARE trial). 30 Concerning the use of chemotherapy in the last month of life, our figures are similarly low to those from another older cohort derived from administrative databases (10% to 13%). 31 Of particular interest, Zaghloul and Murillo 19 examined chemotherapy use at the end of life in a cohort of American patients with PCa at a single institution who died between 2003 and 2010; their proportion of chemotherapy use at 3 months before death (32%) was similar to ours.…”

Section: Discussioncontrasting

confidence: 57%

Cancer Drug Use in the Last Month of Life in Men With Castration-Resistant Prostate Cancer

Aprikian

Vanhuyse

et al. 2019

JOP

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PURPOSE: Several new drug therapies have been approved in CRPC in the past decade. However, little is known about their potential overuse at the end of life. Cancer therapy use at the end of life has been considered an indicator of overtreatment. The study objective was to describe CRPC drug use in the last month of life of CRPC patients in Quebec. PATIENTS AND METHODS: Using administrative databases from the province of Quebec in Canada, we identified patients who received medical or surgical castration treatment, received one or more CRPC drugs (chemotherapy, abiraterone, or bone-targeted therapy), and died between 2001 and 2013. CRPC drug use in the last month of life was the primary outcome. RESULTS: The cohort consisted of 1,148 patients with CRPC. A total of 316 men (27.5%) received a CRPC drug in the last month of life. For those who received chemotherapy, abiraterone, and bone-targeted therapy, 10.2%, 27.8%, and 31.8% received them in the last month of life, respectively. In multivariable analyses, age older than 75 years (odds ratio [OR], 0.75; 95% CI, 0.57 to 0.99), and prostate cancer diagnosis received less than 24 months earlier (OR, 0.43; 95% CI, 0.26 to 0.72) were associated with less CRPC drug use. Relative to dying between 2005 and 2011, dying between 2012 and 2013 (OR 1.60; 95% CI, 1.18 to 2.18) was associated with greater CRPC drug use. CONCLUSION: More than one quarter of patients received CRPC drug therapies in the last month of life. Persistent chemotherapy, abiraterone, bone-targeted therapies, and medical castration drugs in the last month of life may be an indicator of inappropriate and expensive end-of-life care.

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Section: Discussioncontrasting

confidence: 57%

Cancer Drug Use in the Last Month of Life in Men With Castration-Resistant Prostate Cancer

Aprikian

Vanhuyse

et al. 2019

JOP

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“…A detailed description of the SPARE study protocol was previously published [ 18 ]. The study protocol was approved by the relevant institutional review boards and independent ethics committees.…”

Section: Methodsmentioning

confidence: 99%

LHRH sparing therapy in patients with chemotherapy-naïve, mCRPC treated with abiraterone acetate plus prednisone: results of the randomized phase II SPARE trial

Ohlmann

Jäschke

Jaehnig³

et al. 2022

Prostate Cancer Prostatic Dis

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Background Although the benefit of androgen deprivation therapy (ADT) continuation in metastatic castration-resistant prostate cancer (mCRPC) remains controversial, clinical evidence is lacking. Recent results indicated that treatment with abiraterone acetate (AA) plus prednisone (P) further suppresses serum testosterone levels over ADT alone, suggesting that continuation of ADT in the treatment of mCRPC may not be necessary. Methods In this exploratory phase 2 study, mCRPC patients were randomized with a 1:1 ratio to receive either continued ADT plus AA + P (Arm A) or AA + P alone (Arm B). The primary endpoint was the rate of radiographic progression-free survival (rPFS) at month 12. Secondary endpoints included PSA-response rate, objective response, time to PSA progression and safety. Results A total of 68 patients were equally randomized between the two study arms. Median testosterone-levels remained below castrate-levels throughout treatment in all patients. According to the intention-to-treat analysis the rPFS rate was 0.84 in Arm A and 0.89 in Arm B. Moderate and severe treatment-emergent adverse events were reported for 72% of the patients in Arm A and for 85% of the patients in Arm B. Conclusions AA + P treatment without ADT may be effective in mCRPC patients and ADT may not be necessary in patients receiving AA + P.

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“…That is why to discontinue ADT with LHRH agonist is crucial. Our study could be relevant to decide when to nish the treatment with LHRH agonists if we want our patient to recover testosterone and improve his quality of life, but also when we desire to maintain castration avoiding the use and the side effects of these drugs, maybe even in progressive, mCRPC treated with other drugs, as abiraterone [23][24]. The SPARE trial, a multicenter, prospective, randomized, exploratory phase II study, and the retrospective, non-randomized study of Jha et al have evaluated the e cacy of abiraterone plus prednisone alone, without ADT, with excellent results compared to the three drugs together [2][3] and as in the pivotal study COU-AA-302 [25].…”

Section: Resultsmentioning

confidence: 99%

Testosterone recovery after androgen deprivation therapy in prostate cancer: building a predictive model

Borque‐Fernando

Estrada-Domínguez

Esteban

et al. 2021

Preprint

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Purpose: To analyze variability, associated factors, and the design of nomograms for individualized testosterone recovery after androgen deprivation therapy (ADT) withdrawal.Methods: A longitudinal study was performed on 208 patients in 2003-2019 period. The castrate and normogonadic levels were defined as testosterone, 0.50 and 3.50 ng/ml respectively. Cumulative incidence curve describes testosterone recovery. A univariate and multivariate analysis was performed to predict testosterone recovery with the candidate prognostic factors: PSA at diagnosis, Clinical stage, biopsy Gleason score, age at cessation of ADT, duration of ADT, primary therapy for patients, and LHRH agonist. Results: The median followup of the study was 80 months, interquartile range (49,99). The 25% and 81% of patients did not recover the castrate and normogonadic level, respectively. Months of ADT and age at ADT withdrawal were significant predictors for testosterone recovery. We built two nomograms of testosterone estimation recovery at 12, 24, 36 and 60 months. The castration recovery model shows good calibration. The c-index was 0.677, with areas under the ROCcurve (AUC) of 0.74, 0.78, 0.78 and 0.78, at 12, 24, 36 and 60 months, respectively. The normogonadic recovery model had an overestimation of high probabilities. The cindex was 0.683, with AUC values of 0.81, 0.71, 0.71 and 0.70 at 12, 24, 36 and 60 months, respectively.Conclusion: Depending on the age of patients and time of treatment, clinicians can discontinue ADT to maintain castrate levels without treatment with enough confidence, or even recover testosterone to normogonadic levels in short courses of treatment with high probabilities.

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Abiraterone acetate plus LHRH therapy versus abiraterone acetate while sparing LHRH therapy in patients with progressive, metastatic and chemotherapy-naïve, castration-resistant prostate cancer (SPARE): study protocol for a randomized controlled trial

Cited by 12 publications

References 20 publications

Cancer Drug Use in the Last Month of Life in Men With Castration-Resistant Prostate Cancer

Cancer Drug Use in the Last Month of Life in Men With Castration-Resistant Prostate Cancer

LHRH sparing therapy in patients with chemotherapy-naïve, mCRPC treated with abiraterone acetate plus prednisone: results of the randomized phase II SPARE trial

Testosterone recovery after androgen deprivation therapy in prostate cancer: building a predictive model

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