NCT01216202

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 7, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

April 2, 2021

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

4.1 years

First QC Date

October 4, 2010

Results QC Date

January 26, 2021

Last Update Submit

October 3, 2023

Conditions

Rectal Cancer

Keywords

Rectal cancerPreoperative radiotherapyPelvic surgerySexual functionWellbeingHormone levelsSpermatogenesis

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Preoperative RT

Men with rectal cancer treated with preoperative radiotherapy (RT) and surgery.

Radiation: Preoperative radiotherapy

No preoperative RT

Men with rectal cancer or prostate cancer treated with surgery alone (no RT).

Interventions

Preoperative radiotherapyRADIATION

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.

Preoperative RT

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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).

You may qualify if:

  • 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.
  • Informed consent
  • Fluent in Swedish
  • Residents of the Stockholm county area

You may not qualify if:

  • Rectal cancer stadium IV
  • Previous radiotherapy to the pelvic region
  • History or evidence of a second pelvic malignancy
  • Androgen deprivation therapy, Testosterone replacement or Androgen abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ersta Hospital

Stockholm, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (4)

  • 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: 25388654BACKGROUND

  • 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: 26362484BACKGROUND

  • 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: 31350073BACKGROUND

  • 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.

    PMID: 27849668RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood- and semen samples.

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Results Point of Contact

Title
Anna Martling
Organization
Karolinska Institutet
anna.martling@ki.se
+46851770000

Study Officials

  • Anna Martling

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Senior Consultant Surgeon

Study Record Dates

First Submitted

October 4, 2010

First Posted

October 7, 2010

Study Start

April 1, 2010

Primary Completion

May 1, 2014

Study Completion

May 1, 2016

Last Updated

October 4, 2023

Results First Posted

April 2, 2021

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)