An interventional study of 12-week aerobic exercise and cognitive-behavioral therapy in Cancer of Prostate and Insomnia, sponsored by Danish Cancer Society. Completed at 1 site in Denmark. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-05.
Sponsored by Danish Cancer Society · Not applicable, Interventional, and Supportive care
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Among 170 studies in Prostatic Neoplasms with a site in Denmark — 30 open to participants now, 50 under way, 17 of them phase 3. Prostatic Neoplasms · Denmark.
Among the 170 studies in Prostatic Neoplasms with a site in Denmark, this one is the 140th largest by enrollment of the 144 interventional ones that give a count, is one of 14 that started in 2018, is one of 47 with no phase, and was the 112th registered.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.
Browse Prostatic Neoplasms studies →30 of the 170 studies in Prostatic Neoplasms with a site in Denmark are open now. Recruiting first, the newest first:
Regionshospital Nordjylland · Sites in Denmark
Men only
Novartis Pharmaceuticals · Sites in Denmark, United States, Canada and 8 more countries
Ages 18+
Rigshospitalet, Denmark · Sites in Denmark
Ages 18+ · Men only
Vejle Hospital · Sites in Denmark
Ages 18+
Mads Ryo Jochumsen · Sites in Denmark
Ages 18+ · Men only
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
170 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 19 · Phase 2 34 · Phase 3 53 · Phase 4 5
First in 1992; this study’s year is marked. 14 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 12 is below the median of 60 across 5,349 interventional studies indexed under Prostatic Neoplasms.
Median enrollment 176 across the 144 interventional studies, 240 across the 25 observational. Of the 108 that completed or were terminated, 40 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
75 of 170 have an industry lead sponsor. The 10 most frequent:
Danish Cancer Society is the lead sponsor of 22 studies on the registry; none are open to participants now.
Danish Cancer Society has 6 studies filed under Prostatic Neoplasms — fewer than ten, so there is no comparison to draw.
9 of the studies in Prostatic Neoplasms with a site in Denmark that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05794906Phase 3BayerA Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies | 2027-07-30 |
| NCT06764485Phase 3CelgeneA Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer | 2027-09-12 |
| NCT06629779Phase 3PfizerA Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer. | 2027-09-30 |
| NCT07162987Odense University HospitalPrehabilitation to Patients With Prostate Cancer | 2026-11 |
| NCT06480110Rigshospitalet, DenmarkEbastine in Combination With Docetaxel as a Treatment for Castration-resistant Metastatic Prostate Cancer | 2026-12-01 |
Add all 9 to your calendar (.ics) → With an account.
Among the 170 studies in Prostatic Neoplasms with a site in Denmark, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study of a randomized controlled trial aims to evaluate the feasibility of a 12-week sleep program and the randomized controlled trial research procedure. In total 20 participants will be recruited and randomized to the intervention or control group.
This feasibility study of a randomized controlled trial, aims to evaluate the feasibility of a 12-week sleep program consisting on aerobic exercise and cognitive-behavioral therapy. In this study the investigators wish to evaluate the program as well as the randomized controlled trial research procedure.
In total 20 participants will be recruited and randomized to either the intervention group (n=10) or control group (n=10).The intervention group will participate in two exercise sessions each week and four sessions based on cognitive-behavioral therapy for insomnia.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
12-week aerobic exercise, two times per week, and cognitive-behavioral therapy for insomnia in total four sessions
Behavioral: 12-week aerobic exercise and cognitive-behavioral therapy
Patients assigned to the control group will receive usual care
12-week intervention of aerobic exercise training and four session of cognitive-behavioral therapy
Sleep
Measured by actigraphy, to investigate change in sleep from baseline to 12 weeks and the difference in change between intervention - and the control group
Time frame: Change from baseline sleep at 12 weeks
Cardiorespiratory fitness
Measured by watt max test, to investigate change from baseline to 12 weeks and the difference in change between intervention and the control group
Time frame: Baseline, 12-weeks
Fatigue
Measured by the multidimensional fatigue inventory, to investigate change in fatigue from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group
Time frame: Baseline, 12 weeks, 6 month
Physical activity
Measured by the Physical activity Questionnaire to investigate change in physical activity from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group
Time frame: Baseline, 12 weeks, 6 month
Depression
Measured by the Patient Health Questionnaireto, to investigate change in depression from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group
Time frame: Baseline, 12 weeks, 6 month
Anxiety
Measured by the Generalized Anxiety Disorder Questionnaireto, to investigate change in anxiety from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group
Time frame: Baseline, 12 weeks, 6 month
Stress
Measured by Perceived Stress Scale to investigate change in stress from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group
Time frame: Baseline, 12 weeks, 6 month
Quality of life
Measured by European Organization for Research and Treatment Cancer, to investigate change in quality of life from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group
Time frame: Baseline, 12 weeks, 6 month
Sleep quality
Measured by Pittsburgh Sleep Quality Index, to investigate change in sleep quality from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group
Time frame: Baseline, 12 weeks, 6 month
Sleep pattern
Measured by a sleep diary, to investigate change in sleep pattern from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group
Time frame: Baseline, 12 weeks, 6 month
Insomnia
Measured by Insomnia Severity Index, to investigate change in insomnia from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group
Time frame: Baseline, 12 weeks, 6 month
Physical activity
Measured by actigraphy, to investigate change in physical activity from baseline to 12 weeks and the difference in change between intervention - and the control group
Time frame: Baseline, 12 weeks
Ran from Mar 2018 to primary completion in Mar 2019, 12 months.
Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 87. This study's 12 months is below that.
Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 86.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Danish Cancer Society