amifostine anhydrous and Cancer of Prostate studies

Amifostine: A phosphorothioate proposed as a radiation-protective agent. It causes splenic vasodilation and may block autonomic ganglia.
amifostine : An organic thiophosphate that is the S-phospho derivative of 2-[(3-aminopropyl)amino]ethanethiol. A prodrug for the free thiol, WR-1065, which is used as a cytoprotectant in cancer chemotherapy and radiotherapy.

Research Excerpts

Excerpt	Relevance	Reference
"Early toxicity was overall low, proctitis being the most frequent side-effect (23."	2.76	Treatment of low-risk prostate cancer with radical hypofractionated accelerated radiotherapy with cytoprotection (HypoARC): an interim analysis of toxicity and efficacy. ( Giatromanolaki, A; Kalogeris, K; Koukourakis, MI; Kyrgias, G; Mavropoulou, S; Milioudis, N; Nassos, P; Panteliadou, M; Papadopoulou, A; Sivridis, E; Touloupidis, S, 2011)
"Radiation colitis was assessed by clinical, endoscopic and histolopathological criteria."	2.75	Randomized phase II exploratory study of prophylactic amifostine in cancer patients who receive radical radiotherapy to the pelvis. ( Bai, M; Batistatou, A; Briasoulis, E; Capizzello, A; Christodoulou, D; Karavasilis, V; Katsanos, KH; Panelos, I; Tolis, C; Tsekeris, P; Tsianos, EV, 2010)
"Twenty-nine patients with localized prostate cancer were accrued."	2.70	Intrarectal application of amifostine for the prevention of radiation-induced rectal injury. ( Ben-Josef, E; Biggar, S; Han, S; Kaplan, I; Kelly, L; Stamos, B; Tobi, M; Vargas, BJ, 2002)
"Grade 2 proctitis was noted in 18."	1.38	Postoperative pelvic hypofractionated accelerated radiotherapy with cytoprotection (HypoARC) for high-risk or recurrent prostate cancer. ( Abatzoglou, I; Koukourakis, MI; Panteliadou, M; Papadopoulou, A; Sismanidou, K; Touloupidis, S, 2012)
"Patients with localized prostate cancer received amifostine as a rectal suspension 30-45 minutes before daily three-dimensional conformal radiation therapy."	1.35	Intrarectal amifostine during external beam radiation therapy for prostate cancer produces significant improvements in Quality of Life measured by EPIC score. ( Albert, PS; Camphausen, K; Coleman, CN; Cooley-Zgela, T; Crouse, NS; Godette, D; Guion, P; Ménard, C; Sciuto, LC; Simone, NL; Singh, AK; Smith, S; Soule, BP, 2008)
"Twenty-nine patients with localized prostate cancer were accrued."	1.31	A pilot study of topical intrarectal application of amifostine for prevention of late radiation rectal injury. ( Ben-Josef, E; Biggar, S; Bonner, HS; Han, S; Kaplan, I; Kelly, L; Prokop, S; Shaw, LM; Stamos, B; Tobi, M; Vargas, BJ, 2002)

Research

Studies (17)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment Over Time (Late Follow-up 18 Months)

Timeframe	Studies, this research(%)	All Research%
pre-1990	2 (11.76)	18.7374
1990's	1 (5.88)	18.2507
2000's	11 (64.71)	29.6817
2010's	3 (17.65)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Katsanos, KH	1
Briasoulis, E	1
Tsekeris, P	1
Batistatou, A	1
Bai, M	1
Tolis, C	1
Capizzello, A	1
Panelos, I	1
Karavasilis, V	1
Christodoulou, D	1
Tsianos, EV	1
Koukourakis, MI	2
Kyrgias, G	1
Papadopoulou, A	2
Panteliadou, M	2
Giatromanolaki, A	1
Sivridis, E	1
Mavropoulou, S	1
Kalogeris, K	1
Nassos, P	1
Milioudis, N	1
Touloupidis, S	2
Abatzoglou, I	1
Sismanidou, K	1
Ben-Josef, E	4
Han, S	2
Tobi, M	2
Shaw, LM	2
Bonner, HS	2
Vargas, BJ	2
Prokop, S	1
Stamos, B	2
Kelly, L	2
Biggar, S	2
Kaplan, I	2
Kouvaris, J	1
Kouloulias, V	1
Malas, E	1
Antypas, C	2
Kokakis, J	1
Michopoulos, S	2
Matsopoulos, G	2
Vlahos, L	1
Dziuk, T	1
Senzer, N	1
Linares, LA	1
Echols, D	1
Ménard, C	4
Camphausen, K	4
Muanza, T	1
Sears-Crouse, N	1
Smith, S	4
Coleman, CN	4
Mazeron, JJ	1
Kouloulias, VE	1
Kouvaris, JR	1
Pissakas, G	1
Mallas, E	1
Kokakis, JD	1
Mystakidou, K	1
Vlahos, LJ	1
Muanza, TM	1
Albert, PS	3
Godette, D	2
Crouse, NS	3
Cooley-Zgela, T	3
Sciuto, L	1
Singh, AK	2
Guion, P	2
Simone, NL	2
Godette, DJ	1
Sciuto, LC	2
Coleman, J	1
Pinto, P	1
Soule, BP	1
Kligerman, MM	1
Mesina, J	1
Shamsa, F	1
Porter, AT	1
Rubin, P	1
Salazar, O	1
Zagars, G	1
Constine, LS	1
Keys, H	1
Poulter, CA	1
Van Ess, JD	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Amifostine as a Rectal Protector During External Beam Radiotherapy for Prostate Cancer: A Phase II Study[NCT00040365]	Phase 2	30 participants (Actual)	Interventional	2002-06-30	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

The EPIC bowel assessment is a 26 item short form evaluation that assess patient function and bother after prostate treatment. The Expanded Prostate Cancer Index Composite is a self assessment questionnaire designed to measure quality of life in patients with prostate cancer. The questionnaire is scored on a scale of 0-100 with higher scores correlated with higher function and quality of life. For this study, the Bowel Domain was analyzed alongside the RTOG acute and late gastrointestinal morbidity scores. For details re: EPIC, see http://www.med.umich.edu/urology/research/EPIC/EPIC-2.2002.pdf (NCT00040365)
Timeframe: 18 months

Number of Participants Who Had Proctoscopic Examinations

Intervention	scores on a scale (Mean)
Amifostine	0.6

Proctoscopic scoring of mucosal change was performed according to a descriptive scale, described by Wachter et al, which assigns grades of mucosal congestion, telangiectasia, ulcerations, stricture, and necrosis. (NCT00040365)
Timeframe: 3 years

Number of Participants With Adverse Events

Intervention	Participants (Number)
Amifostine	30

Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00040365)
Timeframe: 3 years

Percentage of Participants With a Good Toxicity Outcome Who Experienced an Acute Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer.

Intervention	Participants (Number)
Amifostine	30

A good toxicity outcome is defined as having less than grade 2 on both weeks 5 and 7 of treatment. The Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity scoring scheme and the Rectal Mucosal Toxicity response criteria will be used to assess rectal toxicity. The RTOG measures the rectal toxicities. The physician assigns a grade based on symptoms reported by the patient. For details about the RTOG (method and scoring of radiation morbidity, etc.) see http://www.rtog.org/ResearchAssociates/AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx (NCT00040365)
Timeframe: RTOG Acute was used on week 5 and 7

Percentage of Participants With a Good Toxicity Outcome Who Experienced Late Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer.

Intervention	Percentage of Participants (Number)
Amifostine	20.69

A good toxicity outcome is defined as having less than grade 2 on both weeks 5 and 7 of treatment. Week 5, 7 were during treatment measuring acute toxicity. The Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity scoring scheme and the Rectal Mucosal Toxicity response criteria will be used to assess rectal toxicity. The RTOG measures the rectal toxicities. The physician assigns a grade based on symptoms reported by the patient. For details about the RTOG see http://www.rtog.org/ResearchAssociates/AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx. (NCT00040365)
Timeframe: The late rectal toxicity has been assessed at 1, 3, 6, 12, 18, 24, 36, and 60 months after the completion of treatment.

Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)

Intervention	Percentage of Participants (Number)
Amifostine	83.33

Radiation toxicity consists of the Radiation Therapy Oncology Group(RTOG)acute(within 90 days of treatment)and RTOG late(>90days after treatment). This scoring system assigns a toxicity grade (0-4) based on symptoms with 0 being the best outcome. The Expanded Prostate Cancer Index Composite(EPIC) questionnaire consists of 50 quality of life items divided into 4 domains, urinary, bowel, sexual and hormonal. Each independent domain renders a scoring of 0-100 with 100 being the best score. The EPIC and RTOG scores were correlated not combined. (NCT00040365)
Timeframe: Baseline, week 5, 7 , and months 1, 3, 6, 12, and 18

Intervention	scores on a scale (Mean)
	Baseline bowel function	Baseline bowel bother	Week 5 bowel function	Week 5 bowel bother	Week 5 RTOG	Week 7 bowel function	Week 7 bowel bother	Week 7 RTOG	1 month bowel function	1 month bowel bother	1 month RTOG	3 month bowel function	3 month bowel bother	3 month RTOG	6 month bowel function	6 month bowel bother	6 month RTOG	12 month bowel function	12 month bowel bother	12 month RTOG	18 month bowel function	18 month bowel bother	18 month RTOG
Amifostine	91.13	92.86	71.43	67.33	1.06	69.76	66.38	1.00	84.09	78.08	0.59	79.08	82.78	0.54	85.46	81.86	0.39	83.92	77.65	0.50	83.55	76.28	0.64

Article	Year
Randomized phase II exploratory study of prophylactic amifostine in cancer patients who receive radical radiotherapy to the pelvis. Journal of experimental & clinical cancer research : CR, 2010, Jun-10, Volume: 29 Topics: Adult; Aged; Amifostine; Colitis; Combined Modality Therapy; Endometrial Neoplasms; Female; Follow-U	2010
Treatment of low-risk prostate cancer with radical hypofractionated accelerated radiotherapy with cytoprotection (HypoARC): an interim analysis of toxicity and efficacy. Anticancer research, 2011, Volume: 31, Issue:5 Topics: Aged; Aged, 80 and over; Amifostine; Cytoprotection; Dose Fractionation, Radiation; Feasibility Stud	2011
Amifostine as radioprotective agent for the rectal mucosa during irradiation of pelvic tumors. A phase II randomized study using various toxicity scales and rectosigmoidoscopy. Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al], 2003, Volume: 179, Issue:3 Topics: Aged; Amifostine; Chi-Square Distribution; Data Interpretation, Statistical; Endometrial Neoplasms;	2003
Amifostine and external beam radiation therapy and/or high-dose rate brachytherapy in the treatment of localized prostate carcinoma: preliminary results of a phase II trial. Seminars in oncology, 2003, Volume: 30, Issue:6 Suppl 18 Topics: Aged; Amifostine; Brachytherapy; Humans; Male; Middle Aged; Prostatic Neoplasms; Radiation Injuries;	2003
Clinical trial of endorectal amifostine for radioprotection in patients with prostate cancer: rationale and early results. Seminars in oncology, 2003, Volume: 30, Issue:6 Suppl 18 Topics: Adenocarcinoma; Administration, Rectal; Aged; Amifostine; Humans; Male; Middle Aged; Prostatic Neopl	2003
Phase II multicenter randomized study of amifostine for prevention of acute radiation rectal toxicity: topical intrarectal versus subcutaneous application. International journal of radiation oncology, biology, physics, 2005, Jun-01, Volume: 62, Issue:2 Topics: Administration, Rectal; Amifostine; Female; Genital Neoplasms, Female; Humans; Injections, Subcutane	2005
Comparing measures of acute bowel toxicity in patients with prostate cancer treated with external beam radiation therapy. International journal of radiation oncology, biology, physics, 2005, Aug-01, Volume: 62, Issue:5 Topics: Aged; Amifostine; Chi-Square Distribution; Humans; Male; Middle Aged; Proctoscopy; Prostatic Neoplas	2005
Intrarectal application of amifostine for the prevention of radiation-induced rectal injury. Seminars in radiation oncology, 2002, Volume: 12, Issue:1 Suppl 1 Topics: Adenocarcinoma; Administration, Rectal; Amifostine; Humans; Male; Prostatic Neoplasms; Radiation Dos	2002
Systemic hemibody irradiation for overt and occult metastases. Cancer, 1985, May-01, Volume: 55, Issue:9 Suppl Topics: Amifostine; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Bone Neoplasms; C	1985

Article	Year
Postoperative pelvic hypofractionated accelerated radiotherapy with cytoprotection (HypoARC) for high-risk or recurrent prostate cancer. Anticancer research, 2012, Volume: 32, Issue:10 Topics: Aged; Amifostine; Carcinoma; Cytoprotection; Diarrhea; Dysuria; Humans; Male; Middle Aged; Proctitis	2012
A pilot study of topical intrarectal application of amifostine for prevention of late radiation rectal injury. International journal of radiation oncology, biology, physics, 2002, Aug-01, Volume: 53, Issue:5 Topics: Adenocarcinoma; Administration, Topical; Amifostine; Analysis of Variance; Dose-Response Relationshi	2002
[Minutes of the 23th meeting of the European Society for Therapeutic Radiology and Oncology (ESTRO). Amsterdam, 24-28 October 2004]. Cancer radiotherapie : journal de la Societe francaise de radiotherapie oncologique, 2005, Volume: 9, Issue:2 Topics: Adenocarcinoma; Adult; Aged; Aged, 80 and over; Amifostine; Antineoplastic Agents, Hormonal; Antineo	2005
Intrarectal amifostine suspension may protect against acute proctitis during radiation therapy for prostate cancer: a pilot study. International journal of radiation oncology, biology, physics, 2006, Jul-15, Volume: 65, Issue:4 Topics: Administration, Rectal; Aged; Amifostine; Humans; Male; Pilot Projects; Proctitis; Prostatic Neoplas	2006
Intrarectal amifostine during external beam radiation therapy for prostate cancer produces significant improvements in Quality of Life measured by EPIC score. International journal of radiation oncology, biology, physics, 2008, Jan-01, Volume: 70, Issue:1 Topics: Adenocarcinoma; Administration, Rectal; Aged; Amifostine; Dose-Response Relationship, Drug; Follow-U	2008
Pions, protectors. Examples of a vigorous decade in radiotherapy. American journal of clinical oncology, 1982, Volume: 5, Issue:2 Topics: Amifostine; Animals; Antineoplastic Agents; Drug Evaluation; Drug Therapy, Combination; Elementary P	1982
Topical application of WR-2721 achieves high concentrations in the rectal wall. Radiation research, 1995, Volume: 143, Issue:1 Topics: Administration, Topical; Amifostine; Animals; Chromatography, High Pressure Liquid; Male; Prostate;	1995

amifostine anhydrous and Cancer of Prostate