Who is sponsoring NCT01607879?

NCT01607879 is sponsored by Medical College of Wisconsin.

What drugs are being tested in NCT01607879?

Interventions in NCT01607879: Standard of care ADT + (HMB + arginine + glutamine), Standard of care ADT.

What condition does NCT01607879 study?

NCT01607879 studies Prostate Cancer.

Is NCT01607879 still recruiting?

NCT01607879 is currently completed. Last updated 20 September 2023.

Are results published for NCT01607879?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-09-20 · How we verify

NCT01607879

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Use of β-hydroxy-β-methylbutyrate to Counteract Loss of Muscle Mass and Strength in Older Men With Prostate Cancer Started on Androgen Deprivation Therapy

Completed Phase 2 Results posted Last updated 20 September 2023

What this trial tests

Phase 2 trial testing Standard of care ADT + (HMB + arginine + glutamine) in Prostate Cancer in 48 participants. Completed in 16 February 2021.

Timeline

1 March 2014

Primary endpoint
1 July 2018

16 February 2021

Quick facts

Lead sponsor	Medical College of Wisconsin
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	48
Start date	1 March 2014
Primary completion	1 July 2018
Estimated completion	16 February 2021
Sites	1 location across United States

Drugs / interventions tested

Standard of care ADT + (HMB + arginine + glutamine) — full drug profile →
Standard of care ADT

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Medical College of Wisconsin

Who can join

60 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change From Baseline in Body Composition (Lean Body Mass)
Time frame: Baseline, 3 months
This measure will be the change of lean body mass from baseline reported in kilograms.

Sponsor's own description

This is a study of HMB plus amino acids in older men with prostate cancer starting androgen deprivation therapy (ADT). The investigators hypothesize that the use of this nutritional supplementation will decrease the loss of muscle mass and strength that occurs when men start ADT.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Dietary interventions to improve body composition in men treated with androgen deprivation therapy for prostate cancer: a solution for the growing problem?
Umlauff L, Weber M, Freitag N, Fairman CM, et al · · 2022 · cited 6× · PMID 34193946 · DOI 10.1038/s41391-021-00411-7

Verify or expand the search:

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting

Other Medical College of Wisconsin trials

Trials by the same sponsor.

NCT07260552 — Rapid Engagement for Solutions to Population and Outcomes Through Networked Dialogue for Coronary Heart Disease · not yet recruiting
NCT06795360 — Weight Changes After Incretin-mimetics · NA · not yet recruiting
NCT07228208 — Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes · NA · not yet recruiting
NCT07298460 — Stimulation-based Therapy to Improve Balance in DCM · Phase 1, PHASE2 · not yet recruiting
NCT07434544 — Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D) · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01607879 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medical College of Wisconsin
Last refreshed: 20 September 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01607879.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing