Clinical trial NCT01996852: Improving Erectile Function and Quality of Life After Prostate Cancer Treatment
Official title: Improving Erectile Function and Quality of Life After Prostate Cancer Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Erectile Dysfunction Following Radical Prostatectomy
Erectile Dysfunction Following Simple Prostatectomy
Erectile Dysfunction
Keywords: Erectile dysfunction
ED
Prostate
Prostatectomy
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
name: University Hospitals Cleveland Medical Center
First posted: 2013-11-27
Enrollment: 34
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a research study of erectile dysfunction (ED) in men diagnosed with prostate cancer. 144 patients and partners will participate in the study. The purpose of this study is to test a new treatment that combines a cognitive-behavioral intervention with medication and a vacuum constrictive device to treat ED. This new treatment consists of multiple therapeutic elements that enhance compliance with medical treatment and increase sexual activity through enhancement of the sensual pleasure of sex and partner support.

Detailed description: Erectile dysfunction (ED) is a common side effect of prostate cancer treatment. Existing medical treatment focuses on early penile rehabilitation, aiming to prevent penile shrinkage and preserve nerves and smooth muscles to facilitate erection return. It typically includes administration of phosphodiesterase type 5 inhibitor (PDE-5), application of vacuum constriction devices (VCD) or intracavernous injection immediately after prostate cancer treatment.

To evaluate the proposed intervention, a randomized, controlled longitudinal clinical trial will be conducted to examine the effect of this cognitive-behavioral intervention on early-stage prostate cancer patients with ED and their partners. The proposed study includes a pilot study, a randomized clinical trial (the main study) and data analysis. The study duration for main study participants is 10 months including one month of recruitment and baseline assessment, six months of intervention, and three months of follow-up. The study duration for pilot study participants is 7 months including one month of recruitment and baseline assessment plus six months of intervention.

The Pilot Study A pilot study will be conducted to develop and test the proposed study intervention over 12 months. The pilot study will recruit 36 early-stage prostate cancer patients and their partners. The 36 couples will be randomly assigned to three study arms: (1) standard medical treatment of ED (MED); (2) standard medical treatment of ED plus cognitive-behavioral intervention (MED+CBI); and (3) usual care (UC) in which the study participants will not receive any study intervention, but will continue with standard care that allows patient's request for ED treatment. The purpose to include the usual care group is to collect preliminary data to aid the estimation of intervention effect size, statistic power and sample size, and to compare the intervention outcome with the real world scenario in order to provide the justification for the inclusion or exclusion of the usual care arm in the main study. The pilot study participants will be assessed twice at baseline (T1) and 7 months (T2) only. Doppler Ultrasound of the penis will be performed at T1 and T2 to examine changes in the volume of penile blood flow in patients. Subjects are allowed to opt out of the Doppler Ultrasound test, because this pilot data is exploratory and five or more ultrasound tests per group are sufficient. Collecting and analyzing blood samples will be performed at T1 and T2 and subjects are allowed to opt out of this test as well. The blood sample will be collected in order to test transforming growth factor beta-1 (TGF-ß1) and to assess its relation to erectile function. The result will allow us to evaluate the intervention impact at molecular level and formulate a best possible intervention to ED.

The Main Study During a 4-year clinical trial study, 144 early-stage prostate cancer patients along with their partners will be randomly assigned to two study arms: (1) standard medical treatment of ED (MED) and (2) standard medical treatment of ED plus cognitive-behavioral intervention (MED+CBI). The MED includes administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump). The MED+CBI entails six in-person sessions and five telephone follow-ups over six months. The patients will be assessed on erectile function (EF), quality of life (QOL) and mood at baseline (T1), 7 months (T2) and 10 months (T3). The partners will be assessed on QOL and mood at T1, T2 and T3. Doppler Ultrasound of the penis will be performed at T1 and T2 to examine changes in the volume of penile blood flow among 50 patients who will be consecutively selected from the two study groups, with 25 per study arm.

The long-term primary goals of the study are to:

1. Assess the effect of the new treatment on erection function, quality of life, and mood.
2. Assess the treatment compliance and frequency of sexual activity of the new treatment.
3. Investigate the mechanism in which the new treatment works.

The long-term secondary goals of the study are to:

1. Assess the effect of the new treatment on the quality of life and mood of the patient's partner.
2. Assess the changes in the volume of penile blood flow due to study treatments.

Eligibility criteria: Inclusion Criteria:

* Stage I, II, and III prostate cancer
* Having completed definite treatment of localized prostate cancer (surgery or radiation);
* Presence of erectile dysfunction symptoms;
* Have a stable partner for six months who is willing to participate;
* Sexually active prior to cancer treatment (≥17 on the Sexual Health Inventory For Men- ("SHIM")).
* Prostatectomy with or without radiation for the pilot study patients only.

Exclusion Criteria:

* Receiving hormonal treatment;
* Cognitive impairment (≥5 on the Short Portable Mental Status Questionnaire (SPMSQ));
* Severe marital maladjustment that prevents a patient from benefiting from the proposed intervention (\<85 on the Locke-Wallace Marital Adjustment Test);
* Taking nitrates of any kind;
* Congenital bleeding disorder or predisposition to priapism that is contraindicative to VCD use;
* Having untreated clinical depression and other psychotic mental disorders (e.g., bipolar, schizophrenia) (≥27 on the Center for Epidemiological Studies Depression Scale (CES-D)).
* Patients taking any potent inhibitor of cytochrome P450 3A4 (e.g., ketoconazole, itraconazole, erythromycin, etc).
* Patients taking concomitant alpha-adrenergic blocking agents.
* Patients with a clinically significant abnormality on screening ECG (taken within 12 weeks) that in the opinion of the investigator/co-investigator may increase the patient's cardiovascular risk in this study.
* Patients with a history of left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis).
* Patients with a history of severely impaired autonomic control of blood pressure.
* Patients with resting hypotension (BP \< 90/50 mm Hg), or resting hypertension (BP \> 170/110 mm Hg) at Screening.
* Patients with known hypersensitivity to Sildenafil or other ingredients of Sildenafil.
* Patients with retinitis pigmentosa.
* Patients with active peptic ulceration.
* Patients who have previously experienced non-arteritic ischemic optic neuropathy (NAION).
* Patients taking other phosphodiesterase Type 5 (PDE5) inhibitors.
* Patients taking Coumadin, Pradaxa or other blood thinner drugs.

Primary outcomes:
measure: Erectile Function Improvement
timeFrame: 10 months after start of treatment
measure: Change in Number of Erections
timeFrame: 10 months after start of treatment
measure: Erectile Function Improvement
timeFrame: 7 months after start of treatment
measure: Change in Number of Erections
timeFrame: 7 months after start of treatment
Secondary outcomes:
measure: Sexual Quality of Life (QoL) Improvement
timeFrame: 10 months after start of treatment
measure: Change in Overall Quality of Life (QoL) Score
timeFrame: 10 months after start of treatment
measure: Improved Mood Score
timeFrame: 10 months after start of treatment
measure: Change in Treatment Compliance
timeFrame: 10 months after start of treatment
measure: Change in Frequency of Sexual Activity
timeFrame: 7 months after start of treatment
measure: Change in Frequency of Sexual Activity
timeFrame: 10 months after start of treatment
measure: Change in Treatment Compliance
timeFrame: 7 months after start of treatment
measure: Sexual Quality of Life (QoL) Improvement
timeFrame: 7 months after start of treatment
measure: Change in Overall Quality of Life (QoL) Score
timeFrame: 7 months after start of treatment
Other outcomes:
measure: Self-Efficacy Improvement
timeFrame: 7 months after start of treatment
measure: Self-Efficacy Improvement
timeFrame: 10 months after start of treatment
measure: Change in Level of Sensual Pleasure of Sex
timeFrame: 7 months after start of treatment
measure: Change in Level of Sensual Pleasure of Sex
timeFrame: 10 months after start of treatment
measure: Change in Perceived Partner Support
timeFrame: 7 months after start of treatment
measure: Change in Perceived Partner Support
timeFrame: 10 months after start of treatment
measure: Change in Flaccid Penile Length
timeFrame: 7 months
measure: Change in Flaccid Penile Length
timeFrame: 10 months
measure: Change in Stretched Penile Length
timeFrame: 7 months
measure: Change in Stretched Penile Length
timeFrame: 10 months
measure: Change in Volume of Flaccid Penile Blood Flow
timeFrame: 7 months after start of treatment
measure: Change in Volume of Flaccid Penile Blood Flow
timeFrame: 10 months after start of treatment
measure: TGF-B1 Levels
timeFrame: baseline - 1 week after start of treatment
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
name: Amy Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: