Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-01-10 @ 1:03 AM
Study NCT ID:
NCT01216202
Status:
COMPLETED
Last Update Posted:
2023-10-04
First Post:
2010-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sexual Function and Wellbeing in Males With Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anna.martling@ki.se', 'phone': '+46851770000', 'title': 'Anna Martling', 'organization': 'Karolinska Institutet'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'Adverse events were not monitored.', 'eventGroups': [{'id': 'EG000', 'title': 'Preoperative RT', 'description': 'Men with rectal cancer treated with preoperative therapy (RT) and surgery.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 101, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Preoperative RT', 'description': 'Men with rectal cancer or prostate cancer treated with surgery alone (no RT).', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 77, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Serum Testosterone Levels Between Baseline and After Preoperative Radiotherapy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preoperative RT', 'description': 'Men with rectal cancer treated with preoperative radiotherapy (RT) and surgery.'}, {'id': 'OG001', 'title': 'No Preoperative RT', 'description': 'Men with rectal cancer or prostate cancer treated with surgery alone (no RT).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.3', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'After RT/before surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '3.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The threshold for statistical significance was p = 0.05.', 'groupDescription': 'The association between change in serum testosterone levels and cumulative mean testicular radiation dose was assessed using longitudinal regression analysis (GEE). No preoperative RT contributed with baseline values.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after RT/before surgery.', 'description': 'Fasting morning venous blood samples were collected at baseline, eg prior to oncological treatment. Men with rectal cancer treated with preoperative radiotherapy (RT) had a second blood sample taken afte RT and before surgery, collected the week before surgery and defined as "after RT/before surgery". Elapsed time between start of RT and the second blood sample was median 38 days, ranging from 3 to 195 days depending on the type of preoperative oncological treatment regimen. Testosterone (T) was analysed at the Department of Clinical Chemistry, Karolinska University Hospital, using commercial assays.', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For participants in "No preoperative RT", no blood samples were collected at the time point "after RT/before surgery".'}, {'type': 'PRIMARY', 'title': 'Change in Total Number of Sperms Per Ejaculate Between Baseline and Two Year Follow-up.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'Semen samples', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preoperative RT', 'description': 'Men with rectal cancer treated with preoperative therapy (RT) and surgery with available semen samples.'}, {'id': 'OG001', 'title': 'No Preoperative RT', 'description': 'Men with rectal cancer treated with surgery alone (no RT) with available semen samples.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'Semen samples', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '164.0', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '1140.0'}]}]}, {'title': '1 year after surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'Semen samples', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.15', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '216.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': '2 years after surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'Semen samples', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '187.0'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000'], 'paramType': 'Estimated mean change', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.0', 'ciLowerLimit': '-6.9', 'ciUpperLimit': '-1.0', 'pValueComment': 'The threshold for statistical significance was p=0.05.', 'groupDescription': 'The association between change in total number of sperms per ejaculate and relative mean testicular dose was assessed using longitudinal regression analysis (GEE).', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Model adjusted for time between preoperative radiotherapy (RT) and surgery.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 1 and 2 years after surgery.', 'description': 'Semen samples were collected at the Department of Reproductive Medicine of Karolinska University Hospital after 72h of sexual abstinence and analysed according to World Health Organization 2010 standard. Total number of sperms (million spermatozoa per ejaculate), was calculated by multiplying sperm concentration (million spermatozoa per millilitre semen) with semen volume (milliliter semen/ejaculate). Total number of sperms below 39 million per ejaculate was defined as oligospermia, and 0 million per ejaculate was defined as azoospermia. Semen samples were only collected in men with rectal cancer, not prostate cancer.', 'unitOfMeasure': 'million spermatozoa per ejaculate', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Semen samples', 'denomUnitsSelected': 'Semen samples', 'populationDescription': 'Of the 115 men with rectal cancer included in the study, 21 men left at least one semen sample during the study period and was included in the analysis. 20 of 21 men had RT. In total 40 semen samples was analysed. During follow-up three participants with RT dropped out of the study. Number analysed at each time points represents number of available semen samples at each time point; 19 of 21 at baseline, 9 of 18 1 year after surgery, 12 of 18 2 year after surgery.'}, {'type': 'PRIMARY', 'title': 'Sexual Function', 'timeFrame': '2 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-06'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Preoperative RT', 'description': 'Men with rectal cancer treated with preoperative radiotherapy (RT) and surgery.'}, {'id': 'FG001', 'title': 'No Preoperative RT', 'description': 'Men with rectal cancer or prostate cancer treated with surgery alone (no RT).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Included in the study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'Analysed at Baseline', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'Analysed After RT', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Analysed at baseline', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants with rectal cancer stage I to III planned for rectal resection eligible for the study were enrolled at a tertiary (Karolinska University Hospital) and secondary hospital (Ersta Hospital) in Stockholm during April 2010 and May 2014. Of 372 men with rectal cancer assessed for eligibility, 115 were included in the study.', 'preAssignmentDetails': '18 months after start of inclusion, less than 10% of the participants were treated with surgery alone. To increase the sample size of the unexposed group (no preoperative radiotherapy), 63 men with prostate cancer I to III scheduled for robot assisted prostatectomy were included. Participants with prostate cancer were enrolled at the Urology department at Karolinska University Hospital between May 2012 and January 2013.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Preoperative RT', 'description': 'Men with rectal cancer treated with preoperative radiotherapy (RT) and surgery.'}, {'id': 'BG001', 'title': 'No Preoperative RT', 'description': 'Men with rectal cancer or prostate cancer treated with surgery alone (no RT).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.3', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '63.3', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '61.6', 'spread': '9.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'spread': '4.1', 'groupId': 'BG000'}, {'value': '26.4', 'spread': '3.0', 'groupId': 'BG001'}, {'value': '25.8', 'spread': '3.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ASA score', 'classes': [{'title': 'I', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'II', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}, {'title': 'III', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ASA score is a classification system for physical status ranging from scores I to VI with higher scores indicting worse physical status. Definitions of scores; I = Normal healthy person, II = A patient with mild systemic disease, III = A patient with severe systemic disease.', 'unitOfMeasure': 'Participants'}, {'title': 'Preoperative RT', 'classes': [{'title': 'Short course RT (5x5 Gy)', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}, {'title': 'Long course RT (1.8x28 Gy)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'No RT', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Preoperative chemotherapy', 'classes': [{'title': 'Concomitant chemotherapy', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Full dose chemotherapy', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'No chemotherapy', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood- and semen samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-03', 'studyFirstSubmitDate': '2010-10-04', 'resultsFirstSubmitDate': '2021-01-26', 'studyFirstSubmitQcDate': '2010-10-06', 'lastUpdatePostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-08', 'studyFirstPostDateStruct': {'date': '2010-10-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Serum Testosterone Levels Between Baseline and After Preoperative Radiotherapy.', 'timeFrame': 'Baseline and after RT/before surgery.', 'description': 'Fasting morning venous blood samples were collected at baseline, eg prior to oncological treatment. Men with rectal cancer treated with preoperative radiotherapy (RT) had a second blood sample taken afte RT and before surgery, collected the week before surgery and defined as "after RT/before surgery". Elapsed time between start of RT and the second blood sample was median 38 days, ranging from 3 to 195 days depending on the type of preoperative oncological treatment regimen. Testosterone (T) was analysed at the Department of Clinical Chemistry, Karolinska University Hospital, using commercial assays.'}, {'measure': 'Change in Total Number of Sperms Per Ejaculate Between Baseline and Two Year Follow-up.', 'timeFrame': 'Baseline, 1 and 2 years after surgery.', 'description': 'Semen samples were collected at the Department of Reproductive Medicine of Karolinska University Hospital after 72h of sexual abstinence and analysed according to World Health Organization 2010 standard. Total number of sperms (million spermatozoa per ejaculate), was calculated by multiplying sperm concentration (million spermatozoa per millilitre semen) with semen volume (milliliter semen/ejaculate). Total number of sperms below 39 million per ejaculate was defined as oligospermia, and 0 million per ejaculate was defined as azoospermia. Semen samples were only collected in men with rectal cancer, not prostate cancer.'}, {'measure': 'Sexual Function', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rectal cancer', 'Preoperative radiotherapy', 'Pelvic surgery', 'Sexual function', 'Wellbeing', 'Hormone levels', 'Spermatogenesis'], 'conditions': ['Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '25388654', 'type': 'BACKGROUND', 'citation': 'Buchli C, Tapper J, Bottai M, Holm T, Arver S, Blomqvist L, Martling A. Testosterone and body composition in men after treatment for rectal cancer. J Sex Med. 2015 Mar;12(3):774-82. doi: 10.1111/jsm.12751. Epub 2014 Nov 12.'}, {'pmid': '26362484', 'type': 'BACKGROUND', 'citation': 'Buchli C, Al Abani M, Ahlberg M, Holm T, Fokstuen T, Bottai M, Frodin JE, Lax I, Martling A. Assessment of testicular dose during preoperative radiotherapy for rectal cancer. Acta Oncol. 2016;55(4):496-501. doi: 10.3109/0284186X.2015.1073349. Epub 2015 Sep 11.'}, {'pmid': '31350073', 'type': 'BACKGROUND', 'citation': 'Tapper J, Arver S, Holm T, Bottai M, Machado M, Jasuja R, Martling A, Buchli C. Acute primary testicular failure due to radiotherapy increases risk of severe postoperative adverse events in rectal cancer patients. Eur J Surg Oncol. 2020 Jan;46(1):98-104. doi: 10.1016/j.ejso.2019.07.023. Epub 2019 Jul 19.'}, {'pmid': '27849668', 'type': 'RESULT', 'citation': 'Buchli C, Martling A, Abani MA, Frodin JE, Bottai M, Lax I, Arver S, Holm T. Risk of Acute Testicular Failure After Preoperative Radiotherapy for Rectal Cancer: A Prospective Cohort Study. Ann Surg. 2018 Feb;267(2):326-331. doi: 10.1097/SLA.0000000000002081.'}]}, 'descriptionModule': {'briefSummary': 'Preoperative radiotherapy and pelvic surgery is recommended to many patients with rectal cancer. For men there are theoretical reasons to believe that the treatment may effect hormone levels, spermatogenesis, sexual function and wellbeing. To address these questions a longitudinal observational study was initiated where measurements of androgen hormone levels, semen samples and sexual function were assessed before treatment (baseline) and during a follow-up period of two years.', 'detailedDescription': 'Men with rectal cancer stage I to III planned for resection was included in the study. Men treated with preoperative RT were assigned to the exposed group and men treated with surgery alone were assigned to the unexposed group. Eighteen months after start of inclusion, less than 10% of the participants were treated with surgery alone. To increase the sample size of the unexposed group, men with prostate cancer stage I to III and scheduled for robot-assisted prostatectomy were also included.\n\nParticipants with rectal cancer were enrolled at two centres in Stockholm (Karolinska University Hospital and Ersta Hospital) between 2010 and 2014. Participants with prostate cancer were enrolled at the Urology department of the Karolinska University Hospital in Stockholm between 2012 and 2013.\n\nPatient data, fasting venous blood samples, semen samples and questionnaires regarding sexual function and well being were collected before start of oncological treatment (baseline), 1 and 2 years after surgery. Men treated with preoperative RT for rectal cancer had an additional venous blood sample during the week before surgery. Men with rectal cancer under 55 years of age were offered semen cryopreservation.\n\nParticipants could choose if they wanted to participate in one, two or three of the following parts; hormone analysis, semen analysis and/ or questionnaires regarding sexual function and well being. Semen sampling and cryopreservation was not performed in men with prostate cancer.\n\nChanges in hormone levels, semen measurements and sexual function during follow-up were assessed, and compared between exposed and unexposed participants.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Men with rectal cancer stadium I-III, planned for abdominal surgery with or without preoperative radiotherapy.\n\nMen with prostate cancer stadium I-III planned for robot-assisted prostatectomy (no preoperative radiotherapy).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males diagnosed with rectal cancer stadium I-III, planned for surgery with or without preoperative radiotherapy or males with prostate cancer stadium I-III planned for robot-assisted prostatectomy without preoperative radiotherapy.\n* Informed consent\n* Fluent in Swedish\n* Residents of the Stockholm county area\n\nExclusion Criteria:\n\n* Rectal cancer stadium IV\n* Previous radiotherapy to the pelvic region\n* History or evidence of a second pelvic malignancy\n* Androgen deprivation therapy, Testosterone replacement or Androgen abuse'}, 'identificationModule': {'nctId': 'NCT01216202', 'briefTitle': 'Sexual Function and Wellbeing in Males With Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Sexual Function and Wellbeing in Males Diagnosed With Rectal Cancer', 'orgStudyIdInfo': {'id': '2009/1860-31/2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preoperative RT', 'description': 'Men with rectal cancer treated with preoperative radiotherapy (RT) and surgery.', 'interventionNames': ['Radiation: Preoperative radiotherapy']}, {'label': 'No preoperative RT', 'description': 'Men with rectal cancer or prostate cancer treated with surgery alone (no RT).'}], 'interventions': [{'name': 'Preoperative radiotherapy', 'type': 'RADIATION', 'description': 'Preoperative radiotherapy (RT) was administered as either short course (5Gy x5) or long-course (2Gy x25 or 1.8 Gy x25 with or without 3 fractions of boost to the primary tumor and radiologically malignant lymph nodes) treatment with or without concomitant or sequential chemotherapy. Oncological treatment was decided at a multidisciplinary team conference.\n\nTesticular doses (TDs) was calculated from planning CT-scans and reported as mean cumulative testicular dose. Relative TD was calculated based in the assumption that RT regimens for rectal cancer are bioequivalent and referred to as proportion of prescribed dose absorbed by the testes.', 'armGroupLabels': ['Preoperative RT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Ersta Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Anna Martling', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swedish Cancer Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Senior Consultant Surgeon', 'investigatorFullName': 'Anna Martling', 'investigatorAffiliation': 'Karolinska Institutet'}}}}