An interventional study of High intensity approach and Low intensity approach in Prostate Cancer and Kidney Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Not applicable, Interventional, and Other
Among 78 studies in Prostatic Neoplasms by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — 13 open to participants now, 19 under way, none of them phase 3. Prostatic Neoplasms · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
Among the 78 studies in Prostatic Neoplasms by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, this one is the 11th largest by planned enrollment of the 72 interventional ones, is one of 6 that started in 2025, is one of 15 with no phase, reaches primary completion later than 6 of the 17 other live ones, and was the 69th registered.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 90 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →13 of the 78 studies in Prostatic Neoplasms by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins are open now, in 1 country. Each count lists the studies.
Of the 1,228 Prostatic Neoplasms studies recruiting now, 928 (76%) 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 · all sexes · no healthy volunteers.
The full table on the hub →78 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 6 started in 2025.
Median enrollment 25 across the 72 interventional studies, 61 across the 5 observational. Of the 55 that completed or were terminated, 35 (64%) have results posted.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 582 studies on the registry; 71 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 68 (60%) have results posted.
5 of the studies in Prostatic Neoplasms by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06059118Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsDifluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer | 2027-01-04 |
| NCT06826924Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins7-Days Water-Only Fasting or Ketone Supplementation Trial in Prostate Cancer | 2027-06-03 |
| NCT04363164Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsSequential Testosterone and Enzalutamide Prevents Unfavorable Progression | 2027-07 |
| NCT06138067Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsPatient Navigation Program to Improve Clinical Trial Enrollment in Cancer Patients | 2027-09 |
| NCT07209176Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsPhysician- and Patient-based Barriers to NGS Testing | 2027-09-06 |
Among the 78 studies in Prostatic Neoplasms by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, from their registry updates:
The goal of this clinical trial is to test the utility of patient navigation by comparing high intensity patient navigation to low intensity navigation approaches to improving cancer trial enrollment of patients treated in academic and community cancer centers. Patient navigation is a strategy for increasing patients access to cancer care by helping the participant overcome barriers in the participants communities and within the health care system by providing a bridge between the patient and the health care system. The primary objective of this study is to determine if a high intensity patient navigation program will improve patients enrollment on clinical trial in comparison to a low intensity patient navigation. Participants who agree to participate and are eligible will be randomly assigned to either the high intensity or low intensity approach.
This study is a pilot randomized two arm prospective study of a high versus low intensity patient navigation program with the primary endpoint of clinical trials enrollment rate between the 2 arms. The hypothesis of the study is that a high intensity patient navigation program will improve the enrollment rates on clinical trials. Candidates for this study will already have been identified by the patient navigator as being potentially eligible for a clinical trial. Randomization will be stratified by the type of site: community versus academic. There will be a single futility analysis after approximately 50% of the patients have been randomized and offered a clinical trial. Randomization and data capture will be via REDCap.
The primary endpoint of the study is the enrollment rate on clinical trials. With a sample size of 90 and conservatively assuming a clinical trial enrollment among clinical trial eligible patients of 50%, simulations show the investigators would be able to detect a 25% minimum difference (alternative 75% enrollment) in enrollment rates between the two groups with 84% power using a Z test of proportions with a one-sided alpha level of 0.10.
Patients will receive printed educational material (PEM) which will include information and resources regarding clinical trials/clinical trial participation, cancer center support services; and community resources and services available to cancer patients. The PEM will be reviewed by the clinical trial patient navigator with the patient prior to the clinic visit with the medical oncologist. If the patient is offered participation in a therapeutic clinical trial, the high intensity patient navigation begins. The patient navigator will arrange to meet with the patient to complete a needs assessment to identify and address barriers to trial participation within one week of the visit with the medical oncologist (and clinical trial offer).
Behavioral: High intensity approach
Patients will receive printed educational material (PEM) which will include information and resources regarding clinical trials/clinical trial participation and community resources and services available to cancer patients. The PEM will be reviewed by the patient navigator with the patient prior to the clinic visit with the medical oncologist.
Behavioral: Low intensity approach
PEM, cancer center support services material, and community resources and services available to cancer patients material. The PEM will be reviewed with the patient navigator before the participants appointment with the medical oncologist. If enrolled in a clinical trial, the patient navigator will call the participant biweekly, or more often if they are working to resolve any needs identified in the needs assessment) until the participant is successfully enrolled in the therapeutic clinical trial. The patient navigator will call the participant once weekly for 4 weeks, or less than 4 weeks in other cases including withdrawal from the clinical trial or this navigation study, disease progression, or death. The participant will receive a call 3 months after enrollment on the therapeutic clinical trial to complete the Exit Questionnaire
The participant will receive PEM, and community resources and services available to cancer patients material. The PEM will be reviewed with the patient navigator before the appointment with the medical oncologist. The patient navigator will call the participant 4 weeks after enrollment on the trial. The participant will receive a call 3 months after enrollment on the therapeutic clinical trial to complete the Exit Questionnaire
Number of patients from high intensity navigation program that enroll in clinical trials
Number of patients from high intensity patient navigation program that enroll in clinical trials versus the number of patients from low intensity patient navigation program that enroll in clinical trials.
Time frame: 18 months
Acceptance rate
Acceptance rate of patients on the navigation study.
Time frame: 12 months
Retention rate
Retention rate of patients on the navigation study
Time frame: 18 months
Number of different types of barriers to enrollment
To identify type of potential barriers and total quantity of each type to enrollment on clinical trial reported by patients.
Time frame: 18 months
Started Dec 2025 (actual). Primary completion is estimated for Sep 2027, 21 months after the start.
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 86. This study's planned 21 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 84.
How these figures are worked out, and which studies are left out of them.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins →