Prostate Cancer
Conditions
Brief summary
The objective of this study is to determine if systemically infused allogeneic bone marrow derived mesenchymal stem cells (MSC) home to sites of prostate cancer in men with localized adenocarcinoma of the prostate that are planning to undergo a prostatectomy. Investigators plan to systemically infuse MSCs 4, 6 or 8 days prior to enrolled subjects' planned prostatectomies. Investigators will then quantify the relative amount of donor MSC DNA to recipient DNA present in patients' explanted prostate specimens. This will be accomplished via BEAMing digital PCR. This trial will provide the foundation for future studies aimed at engineering MSCs to deliver a toxin to sites of metastatic prostate cancer.
Interventions
BIOLOGICALAllogeneic Human Mesenchymal Stem Cells
This will be a dose escalation study. The first 3 subjects will receive a single dose of 1 x 10\^6 cells/kg or a maximum dose of 1 x 10\^8 total cells IV 4 days prior to undergoing a planned prostatectomy. The remaining subjects will receive a single dose of 2 x 10\^6 cells/kg or a maximum dose of 2 x 10\^8 total cells IV either 4 or 6 days prior to the planned prostatectomy, and if additional doses of MSCs are able to be expanded, up to 6 additional men will be enrolled with a plan to treat them 8 days prior to the prostatectomy.
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
MSC Donors Inclusion Criteria:(MSC donor cohort): 1. Age ≥18 years, ≤30 years 2. Male sex 3. Donor must meet the selection and eligibility criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT) and FDA 21 CFR Part 1271
Exclusion criteria
(MSC donor cohort): 1. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study. 2. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule. 3. Inability to provide informed consent. MSC Recipients Inclusion Criteria (Treatment cohort): 1. Age ≥18 years 2. Eastern cooperative group (ECOG) performance status ≤2 3. Documented histologically confirmed adenocarcinoma of the prostate 4. Gleason score on diagnostic biopsy specimens of ≥ 6 5. ≥ 3 positive cores within diagnostic biopsy specimens 6. At least one prostate core must contain ≥ 30% prostate cancer 7. Scheduled to undergo a prostatectomy at Johns Hopkins 8. Has not received systemic therapy for prostate cancer (i.e. LHRH agonist/antagonist therapy) 9. Sexual Health Inventory in Men (SHIM) score ≥ 17
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of systemically infused (MSC) DNA relative to recipient DNA at sites of prostate cancer in men with localized adenocarcinoma of the prostate that are scheduled to undergo a prostatectomy | Up to 3 years | Allogeneic MSCs will be quantified through tissue BEAMing and the percent of MSCs per total cell number will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in hormonal function as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy | Baseline to Up to 3 years | Change in total hormonal function score (possible score range from 5-49) on the EPIC survey. |
| Feasibility of infusing MSCs into men with localized prostate cancer who plan to undergo a prostatectomy. | Up to 3 years | The percentage of screened subjects that agreed to receive a pre-prostatectomy infusion of MSCs at the pre-specified time point and subsequently undergo a radical prostatectomy. |
| Determine the proportion of MSC to recipient DNA in the peripheral blood | Up to 3 years | Proportion of MSC to recipient DNA is calculated by number of MSCs over the number of recipient DNA (\[number of MSC\]/\[number of recipient DNA\]) in the peripheral blood. |
| Determine the proportion of MSC to recipient DNA within the seminal vesicle. | Up to 3 years | Proportion of MSC to recipient DNA is calculated by number of MSCs over the number of recipient DNA (\[number of MSC\]/\[number of recipient DNA\]) in the seminal vesicle. |
| Changes in the Sexual Health Inventory for Men (SHIM) survey post-prostatectomy. | Up to 3 years | The SHIM is a measure of sexual function with a score ranging from 1 (severe erectile dysfunction) to 25 (normal function). Participants are required to have a score of \>=17 to be eligible for the study. |
| Change in sexual function as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy | Baseline to Up to 3 years | Change in total sexual function score (possible score range from 10-61) on the EPIC survey. |
| Change in bowel habits as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy | Baseline to Up to 3 years | Change in total bowel habits score (possible score range from 8-62) on the EPIC survey. |
| Change in overall satisfaction as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy | Baseline to Up to 3 years | Change in overall satisfaction score (possible score range from 1-5) on the EPIC survey with a higher score reflecting higher overall satisfaction. |
| Safety as assessed by number of participants experiencing adverse events | Up to 3 years | Number of participants experiencing adverse events as defined by the revised National Cancer Institute Common Toxicity Criteria (NCI CTC), version 4.0 published 14 June 2010. |
| Safety as assessed by number of participants experiencing serious adverse events | Up to 3 years | Number of participants experiencing serious adverse events as defined by the revised National Cancer Institute Common Toxicity Criteria (NCI CTC), version 4.0 published 14 June 2010. |
| Safety as assessed by number of participants experiencing treatment-related adverse events | Up to 3 years | Number of participants experiencing treatment-related adverse events as defined by the revised National Cancer Institute Common Toxicity Criteria (NCI CTC), version 4.0 published 14 June 2010. |
| Change in urinary function as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy | Baseline to Up to 3 years | Change in total urinary function score (possible score range from 5-51) on the EPIC survey. |
Countries
United States
Outcome results
None listed