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| Name | Class |
|---|---|
| Swedish Cancer Society | OTHER |
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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.
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.
Participants 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.
Patient 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.
Participants 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.
Changes in hormone levels, semen measurements and sexual function during follow-up were assessed, and compared between exposed and unexposed participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative RT | Men with rectal cancer treated with preoperative radiotherapy (RT) and surgery. |
| |
| No preoperative RT | Men with rectal cancer or prostate cancer treated with surgery alone (no RT). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative radiotherapy | Radiation | 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. Testicular 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Testosterone Levels Between Baseline and After Preoperative Radiotherapy. | 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. | Baseline and after RT/before surgery. |
| Change in Total Number of Sperms Per Ejaculate Between Baseline and Two Year Follow-up. | 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. | Baseline, 1 and 2 years after surgery. |
| Sexual Function | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Men with rectal cancer stadium I-III, planned for abdominal surgery with or without preoperative radiotherapy.
Men with prostate cancer stadium I-III planned for robot-assisted prostatectomy (no preoperative radiotherapy).
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| Name | Affiliation | Role |
|---|---|---|
| Anna Martling | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ersta Hospital | Stockholm | Sweden | ||||
| Karolinska University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25388654 | Background | 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. | |
| 26362484 | Background | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Preoperative RT | Men with rectal cancer treated with preoperative radiotherapy (RT) and surgery. |
| FG001 | No Preoperative RT | Men with rectal cancer or prostate cancer treated with surgery alone (no RT). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Preoperative RT | Men with rectal cancer treated with preoperative radiotherapy (RT) and surgery. |
| BG001 | No Preoperative RT | Men with rectal cancer or prostate cancer treated with surgery alone (no RT). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Serum Testosterone Levels Between Baseline and After Preoperative Radiotherapy. | 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. | For participants in "No preoperative RT", no blood samples were collected at the time point "after RT/before surgery". | Posted | Mean | Standard Deviation | nmol/L | Baseline and after RT/before surgery. |
|
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Adverse events were not monitored.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Preoperative RT | Men with rectal cancer treated with preoperative therapy (RT) and surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Martling | Karolinska Institutet | +46851770000 | anna.martling@ki.se |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Blood- and semen samples.
|
| Stockholm |
| Sweden |
| 31350073 | Background | 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. |
| 27849668 | Result | 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. |
| Lost to Follow-up |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| ASA score | 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. | Count of Participants | Participants |
|
| Preoperative RT | Count of Participants | Participants |
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| Preoperative chemotherapy | Count of Participants | Participants |
|
Men with rectal cancer treated with preoperative radiotherapy (RT) and surgery.
| OG001 | No Preoperative RT | Men with rectal cancer or prostate cancer treated with surgery alone (no RT). |
|
|
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| Primary | Change in Total Number of Sperms Per Ejaculate Between Baseline and Two Year Follow-up. | 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. | 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. | Posted | Median | Full Range | million spermatozoa per ejaculate | Baseline, 1 and 2 years after surgery. | Semen samples | Semen samples |
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| Primary | Sexual Function | Not Posted | Jun 2024 | 2 years | Participants |
| 0 |
| 101 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | No Preoperative RT | Men with rectal cancer or prostate cancer treated with surgery alone (no RT). | 2 | 77 | 0 | 0 | 0 | 0 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
|
| 1 year after surgery |
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| 2 years after surgery |
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