Table 2:
Selected ongoing randomized controlled trials on diet and lifestyle factors in patients with prostate cancer.
| Name of Trial (NCT No.) | Start | Participants | Inclusion Criteria | Intervention | Outcomes (Primary, Secondary) |
|---|---|---|---|---|---|
| Tangerine or Red Tomato Juice in Treating Patients with Prostate Cancer Undergoing Surgery ( NCT02144649) | June 2015 | 45 | Biopsy-proven prostate cancer scheduled for RP | Daily tangerine or red tomato juice (2 5.5oz. cans) | Feasibility, safety, carotenoid levels in blood and prostate tissue, change in histopathologic and immunohistochemical markers of tumorigenesis |
| Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer. (RCT-EPAII-BCR) ( NCT03753334) | July 2017 | Estimated 30 | Biopsy-proven prostate cancer, biochemical recurrence following RP or RT | Daily MAG-EPA supplement (5g fish oil including 4g purified monoglycerides EPA) | PSADT, red blood cell fatty acid profiles |
| A Study to Examine the Effectiveness of Aspirin and/or Vitamin D3 to Prevent Prostate Cancer Progression (PROVENT) ( NCT03103152) | December 2016 | 104 | Biopsy-confirmed prostate cancer, clinical stage <T3, Gleason 6 or 7, serum PSA ≤15ng/mL, <10mm of cancer in single core | Daily Vitamin D (4000IU) alone or with high (300mg) or low (100mg) dose aspirin | Feasibility; progression as measured by changes in lesions on multi-parametric MRI, rising PSA, and/or increased Gleason score or maximum cancer core length; toxicity |
| Trial of Curcumin to Prevent Progression of Low-risk Prostate Cancer Under Active Surveillance ( NCT03769766) | January 2019 | Estimated 291 | Biopsy-proven prostate cancer, Clinical stage T1c-T2a/b, Gleason ≤6 with no pattern 4, serum PSA ≤10ng/mL, <4 cores with cancer | Twice daily curcumin supplement (500mg BCM-95) | Rate of progression as defined by receipt of primary therapy (RP, RT, hormonal therapy) or pathologic progression (>4 cores involved, ≥50% of any core involved, Gleason ≥4) |
| Cannabis Oil and Radiation Therapy for the Management of Pain ( NCT03763851) | January 2019 | Estimated 420 | Metastatic carcinoma of the prostate, lung, or breast | High (2.5mg THC/2.5mg CBD) or low (1mg THC/1mg CBD) dose cannabis capsule with RT | Cancer pain intensity and quality, QOL, functional status, fatigue, cognitive status |
| Active Surveillance Exercise Clinical Trial (ASX) ( NCT02435472) | May 2016 | Estimated 150 | Biopsy-proven prostate cancer on AS, clinical stage <T3, Gleason ≤6 or 3+4 in <34% of cores, serum PSA ≤10 ng/ml or PSAD <0.15 | 4 home-based walking sessions/week at 55–75% individual exercise capacity | Cancer biomarker changes, circulating & tumor biomarkers, general and prostate cancer-specific anxiety, adherence to active surveillance |
| CHAMP: A Randomized Controlled Trial of High-intensity Aerobic and Resistance Exercise for Metastatic Prostate Cancer ( NCT02613273) | July 2016 | Estimated 39 | Biopsy-proven metastatic castrate resistant prostate cancer on ADT with GnRH agonist/antagonist or prior bilateral orchiectomy | Three sessions per week of either aerobic exercise consisting of two high-intensity interval training workouts and one continuous vigorous intensity workout or resistance exercise for 12 weeks | Feasibility, tolerance, safety, general and prostate cancer-specific QOL, anxiety, depression, pain, physical function, strength |
| INTense Exercise foR surVivAL Among Men With Metastatic Castrate-Resistant Prostate Cancer (INTERVAL) ( NCT02730338) | December 2015 | Estimated 866 | Biopsy-proven metastatic castrate resistant prostate cancer on ADT with GnRH agonist/antagonist or prior bilateral orchiectomy | 24 28-day cycles of high intensity aerobic and resistance training three times per week, psychosocial support | Overall survival; time to prostate cancer progression; symptomatic skeletal related events; biomarker analysis of inflammatory markers, insulin/glucose metabolism, and androgen biosynthesis; QOL; physical function; pain; opiate/analgesic use |
| Comprehensive Yoga Program (SKY) as Adjunct Therapy for Prostate Cancer ( NCT03220945) | January 2016 | 44 | RT for prostate cancer | Yoga instruction (Week 1: 3 hours daily for 5 days, Weeks 2–13: 2 hours weekly) | Change in QOL, depression, anxiety, psychological well-being, fatigue, and pain, change in serum antioxidants, serum oxidative stress, and hair/salivary cortisol |
| A Randomized Controlled Trial of Diet and Exercise Interventions among Men with Prostate Cancer - II (Prostate 8 - II) | May 2018 | Estimated 200 | Biopsy-proven prostate cancer scheduled for RP | 4-arm diet and exercise intervention for 2 years, with different combinations of tools that may include a web portal with lifestyle tracking, text messaging, heart rate monitor and resistance bands, and exercise and diet telephone coaching | Change in Decipher score, mRNA expression patterns, PSA, recurrence rate, body weight, waist and hip circumference, fasting glucose, hemoglobin A1C, lipids, antioxidant levels, CRP, physical activity, QOL, sleep quality, barriers, acceptability |
| Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance ( NCT01238172) | January 2011 | 464 | Biopsy-proven prostate cancer, clinical stage ≤ T2a, <25% of tissue positive for cancer, ≤50% of any one biopsy tissue core positive for cancer | Dietary education and telephone counseling sessions | Disease progression, time to progression, time to treatment, QOL, dietary recall |