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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05574712
Other study ID # J2258
Secondary ID IRB00338335
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date January 1, 2024
Est. completion date July 2026

Study information

Verified date March 2024
Source Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

For men with prostate cancer that involves the nearby lymph nodes (N1) standard treatment varies. Many men undergo radical prostatectomy (total removal of the prostate) along with the removal of nearby lymph nodes. Other men may opt for androgen deprivation therapy (ADT, a therapy that blocks testosterone) using the two drugs leuprolide and abiraterone - with or without radiation. This research is being done to investigate whether the use of leuprolide and abiraterone, when given in combination with a drug that blocks a molecule that senses oxygen needs by cancer cells, belzutifan, can kill cancer cells in the body prior in men who are planning on having the prostate surgically removed.


Description:

Eligible participants will receive 1 dose of leuprolide on day 1 as a subcutaneous injection and abiraterone and belzutifan as pills to take every day for 89 days. Participants will then undergo radical prostatectomy as a standard of care to treat prostate cancer approximately 2 weeks after finishing the study drugs. Participants will have PSA checked 1 year and 2 years after surgery. The list of study procedures (some of which are likely to be part of regular cancer care) will include the collection of data from medical records, imaging tests (CT/MRI/ Prostate-Specific Membrane Antigen Scan PSMA/ Positron Emission Tomography PET CT) to evaluate tumors, and blood collection.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Neoadjuvant treatment
Each drug will be dosed at its respective FDA-approved dose. These dosages are as follows: leuprolide acetate 22.5 mg depot injection x one dose, abiraterone acetate 1000 mg by mouth daily, and belzutifan120 mg administered by mouth once daily. All men will also be treated with prednisone 5 mg by mouth twice daily while on abiraterone acetate in order to blunt its associated mineralocorticoid side effects

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Outcome

Type Measure Description Time frame Safety issue
Other Overall Survival Estimate of Participants The overall survival estimate two years after the last patient has accrued. 2 years
Primary Rate of near pathological complete response (pCR) The rate of near pathological complete response (i.e. =5 mm of residual tumor) as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant leuprolide acetate, abiraterone acetate, and belzutifan. 12 weeks
Secondary Negative Margin Rate The negative margin rate as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant treatment 12 weeks
Secondary Rate of Pathologic T3 disease The rate of pathologic T3 disease as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant treatment. 12 weeks
Secondary Rate of radiographic disappearance of prostate nodules Rate of radiographic disappearance of MRI detectable significant prostate nodules (i.e. =0.5 cm in size) following 3-months (12 weeks) of neoadjuvant treatment. 12 weeks
Secondary Proportion of participants receiving adjuvant radiation therapy The proportion of men who receive adjuvant radiation therapy within 1-year of prostatectomy. Up to 1 year after prostatectomy
Secondary Biochemical progression measured by Prostate Specific Antigen (PSA) The biochemical (i.e. PSA) progression free survival estimate two years after the last patient has accrued (i.e. confirmed PSA post-radical prostatectomy =0.2 ng/mL). 2 years
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