Short Androgen Suppression and Radiation Dose Escalation for Intermediate- and High-Risk Localized Prostate Cancer: Results of EORTC Trial 22991

Bolla, M.; Maingon, P.; Carrié, C.; Villà, Salvador; Kitsios, Petros; Poortmans, Philip; Sundar, Santhanam; Steen-Banasik, Elzbieta M. van der; Armstrong, John G.; Bosset, Jean-François; Herrera, Fernanda G.; Pieters, Bradley R.; Slot, Annerie; Bahl, Amit; Ben-Yosef, Rahamim; Boehmer, Dirk; Scrase, Christopher; Renard, Laurette; Shash, Emad; Coens, Corneel; Bergh, Alfons C.M. van den; Collette, Laurence

doi:10.1200/jco.2015.64.8055

Cited by 194 publications

(130 citation statements)

References 31 publications

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“…Recently, both retrospective and prospective clinical trials have published that men with locally invasive or lymph node positive disease have improved progression free survival when adjuvant ADT is employed in addition to surgery or radiotherapy alone [39,354,355]. The findings are in keeping with the current trends for combination therapies: e.g.…”

Section: Future Clinical Trialssupporting

confidence: 68%

Androgen Deprivation Therapy (ADT), Metabolic Syndrome and Metastatic Prostate Cancer: In Vivo and In Vitro Assessments of Effects of Metformin

Rhee¹

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Research Title -In vivo In this translational research PhD project, we conducted a randomized, placebo-controlled clinical trial named ADT and Adjuvant Metformin (ADMET) trial to determine the metabolic and therapeutic effects of treating hyperinsulinaemia in men starting ADT using a diabetic medication called metformin. Men who had been diagnosed with metastatic PCa and commencing ADT as a standard strategy provided the opportunity to study the physiological and pathological impact of the acute rise in insulin levels resulting from the iatrogenic hypogonadism [6]. To assess for the therapeutic benefits of metformin, we used a variety of novel technologies such as circulating tumour cell (CTC) enumeration, culture, transcriptomic analysis, and molecular imaging.The clinical trial was commenced in September 2014 and was completed in March 2017. It concluded that hyperinsulinaemia and MS is a phenomenon that affects most patients when using ADT, although the changes can be ameliorated by metformin. The use of medication was associated with the reduced need for treatment of MS with agents such as statins and progression to CRPC. Further, the trial confirmed that insulin resistance at the time of starting treatment is associated with early development of CRPC and progression of the disease.Progression free survival was also demonstrated using a novel molecular imaging called Prostate Specific

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Section: Future Clinical Trialssupporting

confidence: 68%

Androgen Deprivation Therapy (ADT), Metabolic Syndrome and Metastatic Prostate Cancer: In Vivo and In Vitro Assessments of Effects of Metformin

Rhee¹

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“…HRQOL was assessed with the QLQ-C30 and the QLQ-PR25. Hormonal treatment symptoms, sexual activity and functioning scales were clinically significantly impaired at 6 months and 1 year, without any marked difference between the arms from year 2 onward (8). …”

Section: Discussionmentioning

confidence: 97%

“…It is reassuring that patients were not worse at 24 months for the majority of the sexual and hormone/vitality questions. This is important, because for intermediate-risk disease and high-risk disease patients, the addition of short-term and long-term ADT to radiation, respectively, has improved overall and cancer-specific survival in multiple randomized trials (1–8). …”

Section: Discussionmentioning

confidence: 99%

“…The addition of short-term and long-term ADT to radiation, respectively, has improved overall and cancer-specific survival in multiple randomized trials (1–8). Despite its benefits, ADT has a number of potential side effects including sexual dysfunction (9), osteoporosis and bone fractures (10), vasomotor symptoms (hot flashes) (11), decreased muscle and increased fat (12), fatigue (13), anemia (14), and thromboembolic events (15) among others.…”

Section: Introductionmentioning

confidence: 99%

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External Beam Radiation Therapy or Brachytherapy With or Without Short-course Neoadjuvant Androgen Deprivation Therapy: Results of a Multicenter, Prospective Study of Quality of Life

Sanda

Liu

et al. 2017

International Journal of Radiation Oncology*Biology*Physics

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PURPOSE The long-term effects of neoadjuvant androgen deprivation therapy (NADT) with radiation therapy on participant-reported health-related quality of life (HRQOL) have not been characterized in prospective multi-center studies. We evaluated HRQOL for 2 years among participants undergoing radiation therapy (RT) with or without NADT for newly diagnosed, early-stage prostate cancer. METHODS We analyzed longitudinal cohort data from the Prostate Cancer Outcomes and Satisfaction with Treatment Quality Assessment Consortium to ascertain the HRQOL trajectory of men receiving NADT with external beam radiation therapy (EBRT) or brachytherapy (BT). HRQOL was measured with the EPIC-26 questionnaire at 2, 6, 12, and 24 months after the initiation of NADT. We used Chi-square or Fisher’s Exact test to compare the shift percentages between groups that did or did not receive NADT. Analyses were conducted at the two-sided 5% significance level. RESULTS For subjects receiving EBRT, questions regarding the ability to have an erection, ability to reach an orgasm, quality of erections, frequency of erections, ability to function sexually, and lack of energy were in a significantly worse dichotomized category for the patients receiving NADT. Comparing baseline versus 24 months, 24%, 23%, and 30% of participants receiving EBRT plus NADT shifted to the worse dichotomized category for the ability to reach an orgasm, quality of erections, and ability to function sexually compared to 14%, 13% and 16% in the EBRT group, respectively. CONCLUSION Compared to baseline, at 2 years participants receiving NADT plus EBRT compared with EBRT alone had worse HRQOL, as measured by the ability to reach orgasms, quality of erections, and ability to function sexually. However, there was no difference in the ability to have an erection, frequency of erections, overall sexual function, hot flashes, breast tenderness/enlargement, feeling depressed, lack of energy or change in body weight. The improved survival in intermediate and high-risk patients receiving ADT and EBRT necessitates pre-treatment counseling of the HRQOL impact of ADT and EBRT.

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“…Both of those studies administered HT with standard‐dose EBRT (66.6‐70.0 grays [Gy]), which has demonstrated inferior biochemical control compared with dose‐escalated (DE) EBRT . The evidence of benefit from its addition to DE‐EBRT in intermediate‐risk disease is mixed, with recent prospective data supporting its efficacy …”

Section: Introductionmentioning

confidence: 99%

PMH 9907: Long‐term outcomes of a randomized phase 3 study of short‐term bicalutamide hormone therapy and dose‐escalated external‐beam radiation therapy for localized prostate cancer

McPartlin

Glicksman

Pintilie

et al. 2016

Cancer

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Short Androgen Suppression and Radiation Dose Escalation for Intermediate- and High-Risk Localized Prostate Cancer: Results of EORTC Trial 22991

Abstract: Six months of concomitant and adjuvant AS improves biochemical and clinical DFS of intermediate- and high-risk cT1b-c to cT2a (with no involvement of pelvic lymph nodes and no clinical evidence of metastatic spread) prostatic carcinoma, treated by radiation.

Cited by 194 publications

References 31 publications

Androgen Deprivation Therapy (ADT), Metabolic Syndrome and Metastatic Prostate Cancer: In Vivo and In Vitro Assessments of Effects of Metformin

Androgen Deprivation Therapy (ADT), Metabolic Syndrome and Metastatic Prostate Cancer: In Vivo and In Vitro Assessments of Effects of Metformin

External Beam Radiation Therapy or Brachytherapy With or Without Short-course Neoadjuvant Androgen Deprivation Therapy: Results of a Multicenter, Prospective Study of Quality of Life

PMH 9907: Long‐term outcomes of a randomized phase 3 study of short‐term bicalutamide hormone therapy and dose‐escalated external‐beam radiation therapy for localized prostate cancer

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