An interventional study of Sexual and urological intervention in Prostate Cancer, sponsored by Danish Cancer Society. Completed at 1 site in Denmark. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-04.
Sponsored by Danish Cancer Society · Not applicable, Interventional, and Supportive care
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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 95th largest by enrollment of the 144 interventional ones that give a count, is one of 13 that started in 2014, is one of 47 with no phase, and was the 67th 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 to 75 Years · all sexes · healthy volunteers too.
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. 13 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 72 is above 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.
Today prostate cancer (PC) treatment with curative intent is primarily surgical removal of the prostate gland (prostatectomy) which may be associated with immediate and long lasting erectile dysfunction and decline in urinary function. Besides these physical late effects patients operated for PC have a twofold increased risk for depression up to ten years after the diagnosis. To reduce these late effects affecting both patient and partner the investigators have developed a sexual and urological intervention (PROCAN). The intervention is based on epidemiological data, evidence from previous clinical trials, a feasibility study and qualitative explorations among PC patients and partners. The investigators hereby suggest the conduction of a randomized controlled trial to test the effect of the PROCAN intervention on urological and sexual dysfunction, couples adjustment and quality of life. Results of the proposed trial may provide clinicians and decision makers with the evidence needed to optimize rehabilitation after PC.
Although the potential negative impact of prostate cancer on sexual and urological function is well documented there is no evidence based and standardized rehabilitation offer available for Danish couples affected by prostate cancer. This study proposal is based on a thorough literature review on PC treatment and late effects and interventions targeting sexual and urological late effects and a qualitative study including interviews with 6 couples affected by PC. The literature review showed that; medical treatment is effective for the treatment of erectile dysfunction, psychosocial intervention may ease sexual problems secondary to operation for prostate cancer and sexual counseling may improve compliance with medical treatment of erectile dysfunction. In regard to treatment of urological dysfunction studies showed that the effect of pelvic floor muscle training is enhanced by follow-up instructions by physiotherapist. Our interview study among patients operated for prostate cancer and their partners indicated a general need and demand for professional help to discuss the changed sexual life. Also studies have shown that health professionals find it difficult to discuss sexual problems with the patients. Medical treatment for erectile dysfunction is prescribed to patients operated for prostate cancer, however the treatment is not offered systematically in all hospitals and furthermore the drugs are sold on the internet.In view of this knowledge we determine that there is a need for studies which include patients systematically offered medical treatment for erectile dysfunction and further is offered sexual counseling and thus focusing on: i) treatment of physical, psychological and social aspects of sexual dysfunction ii) improvement of compliance with the medical treatment for erectile dysfunction and iii) reducing barriers among patients and health professionals for resolving sexual problems secondary to operation for prostate cancer.
The purpose of the PROCAN study is in a randomized design to test the effect of a theory based intervention on sexual and urological dysfunctions secondary to operation for prostate cancer. The PROCAN intervention consists of: i) Digital Video Disc (DVD) instruction in pelvic floor muscle training ii) group instructions in pelvic floor muscle training by physiotherapist including up to three individually follow-up and ii) up to six couple sessions performed by a sexual nurse counselor. The intervention is based on social and cognitive behavioral techniques and techniques derived from sexual therapy and counseling with a psycho-educational approach, in which sexuality is defined as a multidimensional construct involving biological, psychological and social aspects. The intervention is documented and developed in collaboration with urologists, physiotherapists and sexologists. The investigators will enroll patients and partners from the Urological Department Rigshospitalet and randomize 160 couples. Patients and partners will be randomized (1:1) to standard care plus the PROCAN intervention and to standard care (control Group). The investigators hypothesize that the PROCAN intervention will:
Inclusion Criteria: Patients operated for primary prostate cancer with open or robot-assisted surgery using nerve sparring or non-nerve sparring technique living with a female partner and reported being sexually active before the operation.
Exclusion Criteria:Patients with other cancers (except non-melanoma skin cancer) within 5 years, major psychiatric disorder, abuse of alcohol or drugs, dementia, e.g. Alzheimer's disease and patients, who do not understand or speak Danish. Patients, who reported not being sexually active before the operation and partners who do not understand or speak Danish.
Standard care and the PROCAN intervention consisting of i) DVD instruction in pelvic floor muscle training ii) group instructions in pelvic floor muscle training by physiotherapist including three individually follow-up and ii) up to six couple sessions performed by a sexual nurse counselor.
Behavioral: Sexual and urological intervention
Standard care consists of:systematic offer of medical treatment for erectile dysfunction, if not contra indicated. The medical treatment will consist of either daily treatment with Cialis 5 mg or phosphodiesterase type 5 inhibitor on demand before sexual activity. Alternatively use of alprostadil as either urethral pin or penile injection. Furthermore standard treatments include preoperative instruction in pelvic floor muscle training, regular outpatient visits and possible referral to rehabilitation in accordance with the rules that apply to the Danish Health legislations. In case of prolonged incontinence the patients may on request be referred to a private practicing physiotherapist.
Sexual and urological intervention consisting of: i) DVD instruction in pelvic floor muscle training ii) group instructions in pelvic floor muscle training by physiotherapist including three individually follow-up and ii) up to six couple sessions performed by a sexual nurse counselor.
Erectile function measured by the International Index of Erectile Function (IIEF-15)
To investigate the change in erectile function among patients in intervention- and the control group from baseline to 8 and 12 months follow up and the difference in change between intervention - and the control group
Time frame: Baseline, 8 months and 12 months
Sexual satisfaction measured by IIEF-15
To investigate the change in sexual satisfaction among patients from baseline to 8 and 12 months follow up and the difference in change between intervention - and the control group
Time frame: Baseline, 8 and 12 months
Female sexual satisfaction measured by The Female Sexual Function Index (FSFI)
To investigate the change in sexual satisfaction among female partners from baseline to 8 and 12 months follow up and the difference in change between intervention - and the control group
Time frame: Baseline, 8 and 12 months
Female Sexual Distress measured by the Female Sexual Distress Scale (FSDS)
To investigate the change in female sexual distress from baseline to 8 and 12 months follow up and the difference in change between intervention - and the control group
Time frame: Baseline, 8 and 12 months
Urological function measured by The Expanded Prostate Cancer Composite Index (EPIC-26)
To investigate the change in urological function among patients from baseline to 8 and 12 months follow up and the difference in change between intervention - and the control group
Time frame: Baseline, 8 and 12 months
Marital function measured by The Dyadic Adjustment Scale (DAS)
To investigate the change in marital function among patients and partners from baseline to 8 and 12 months follow up and the difference in change between intervention - and the control group
Time frame: Baseline, 8 and 12 months
Health related quality of life measured by The Short Form Health Survey (SF-36)
To investigate the change in health related quality of life among patients and partners from baseline to 8 and 12 months follow up and the difference in change between intervention - and the control group
Time frame: Baseline, 8 and 12 months
Anxiety measured by The Symptom Check List (SCL-92)
To investigate the change in anxiety among patients and partners from baseline to 8 and 12 months follow up and the difference in change between intervention - and the control group
Time frame: Baseline, 8 and 12 months
Depression measured by The Major Depression Inventory (MDI)
To investigate the change in depressive symptoms among patients and partners partners from baseline to 8 and 12 months follow up and the difference in change between intervention - and the control group
Time frame: Baseline, 8 and 12 months
The record gives a start of May 2014, a primary completion of Jan 2019 and a completion of Feb 2021. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Danish Cancer Society