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NCT04288336
Daily, Long-Term Intermittent Fasting for the Prevention of PSA-Recurrence in Patients With Localized Prostate Cancer After Radical Prostatectomy
EARLY_PHASE1 trial testing Food Diary in Stage I Prostate Cancer AJCC v8. Withdrawn.
25 March 2022
Quick facts
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Start date | 8 January 2020 |
| Primary completion | 25 March 2022 |
| Estimated completion | 25 March 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Food Diary
- Preventative Dietary Intervention
- Questionnaire Administration
Conditions studied
- Stage I Prostate Cancer AJCC v8 — all drugs for Stage I Prostate Cancer AJCC v8 →
- Stage II Prostate Cancer AJCC v8 — all drugs for Stage II Prostate Cancer AJCC v8 →
- Stage IIA Prostate Cancer AJCC v8 — all drugs for Stage IIA Prostate Cancer AJCC v8 →
- Stage IIB Prostate Cancer AJCC v8 — all drugs for Stage IIB Prostate Cancer AJCC v8 →
Sponsor
Mayo Clinic
Who can join
18 and older, male only, with Stage I Prostate Cancer AJCC v8 or Stage II Prostate Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This early phase I trial studies the feasibility of a daily, long-term intermittent fasting routine in preventing or delaying a rise in prostate specific antigen (PSA) levels in patients with prostate cancer that has not spread to other parts of the body (localized) and who have undergone radical prostatectomy. PSA is a protein produced by both normal and cancer cells. Following a daily fasting routine after treatment for prostate cancer may lower the risk of patients' PSA level rising above 0.4 ng/mL, which is also called PSA-recurrence. A PSA-recurrence can sometimes mean that the disease has returned and/or progressed.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Effect of fasting on cancer: A narrative review of scientific evidence.
Tiwari S, Sapkota N, Han Z. · · 2022 · cited 39× · PMID 35848874 · DOI 10.1111/cas.15492 -
Neuroendocrine Tumors: A Comprehensive Review on Nutritional Approaches.
Muscogiuri G, Barrea L, Cantone MC, Guarnotta V, et al · · 2022 · cited 11× · PMID 36139562 · DOI 10.3390/cancers14184402 -
PGC1 alpha coactivates ERG fusion to drive antioxidant target genes under metabolic stress.
Dhara A, Aier I, Paladhi A, Varadwaj PK, et al · · 2022 · cited 6× · PMID 35508713 · DOI 10.1038/s42003-022-03385-x -
The Clinical Impact of Time-restricted Eating on Cancer: A Systematic Review.
Stringer EJ, Cloke RWG, Van der Meer L, Murphy RA, et al · · 2025 · cited 5× · PMID 39212676 · DOI 10.1093/nutrit/nuae105
Verify or expand the search:
- PubMed search for NCT04288336
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Food Diary
Trials testing the same drug.
- NCT05583890 — A Case-control Study Comparing Glycaemic Control in Pancreatic Cancer Patients vs Healthy Matched Individuals. · completed
- NCT04275479 — Diabetes/ Endocrine Surveillance in SDS · terminated
Other recruiting trials for Stage I Prostate Cancer AJCC v8
Currently open trials in the same condition.
- NCT07276438 — Image-Guidance and Online Adaptation With Stereotactic Body Radiation Therapy for the Treatment of Localized Prostate Ca · NA · recruiting
- NCT06940271 — Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy · NA · recruiting
- NCT06995053 — Computed Tomography-Guided Stereotactic Body Radiation Therapy With Intrafraction Motion Monitoring for the Treatment of · NA · recruiting
- NCT06733350 — Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer · Phase 4 · recruiting
- NCT06325046 — Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer · NA · recruiting
Other Mayo Clinic trials
Trials by the same sponsor.
- NCT07126548 — A Point of Prostate Cancer Diagnosis Virtual Reality Assistant Intervention in Supporting Newly Diagnosed Black Men · NA · not yet recruiting
- NCT07221656 — Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration · not yet recruiting
- NCT06891001 — The Utilization of a Shoe Insert on Individuals With Unilateral Greater Trochanteric Pain Syndrome on Single Leg Stance, · NA · not yet recruiting
- NCT07169799 — Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE) · NA · recruiting
- NCT07086183 — Perioperative Risk in Patients on Chronic Aspirin Undergoing Craniotomy · 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)
- Trial protocol + status: ClinicalTrials.gov NCT04288336 (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 Mayo Clinic
- Last refreshed: 11 July 2022
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/NCT04288336.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing