Prostate CancerPhase 2NCT03716739
Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency
A Phase 2 study testing Testosterone Cypionate 100 MG/ML in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
The purpose of this phase II trial is to determine the efficacy and safety of testosterone replacement therapy (TRT) in improving the symptoms of androgen deficiency and health-related quality of life in men with prostate cancer who have undergone radical prostatectomy. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Testosterone Cypionate 100 MG/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Mar 2019to 16 Jul 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men with prostate cancer, who have Stage pT2, N0, M0 lesions (confined to the gland); Combined Gleason score of 7 (3+4 elements) or less; Preoperative PSA less than 10 ng/ml; Stable and undetectable PSA level (PSA less than 0.1 ng/mL using an assay that has a functional sensitivity of 0.1 ng/mL) for at least two years after radical prostatectomy.
- Age: 40 years and older
- Presence of symptoms related to sexual dysfunction, fatigue/low vitality, or physical dysfunction.
- An average of two fasting, early morning serum testosterone levels, measured by LC-MS/MS, less than 275 mg/dL and/or free testosterone by equilibrium dialysis <60 pg/mL. middle-aged and older men with mean testosterone levels > 300 ng/dL.
- Ability and willingness to provide informed consent
Who cannot join
- Men who have undergone radiation therapy
- Men receiving androgen deprivation therapy will be excluded.
- Hemoglobin <10 g/dL or >16.5 g/dL
- Severe untreated sleep apnea
- Allergy to sesame oil
- Uncontrolled heart failure
Show all 13Show fewer
- Myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke within 3 months
- Serum creatinine >2.5 mg/dL; ALT 3x upper limit of normal;
- Hemoglobin A1c >7.5% or diabetes requiring insulin therapy
- Body mass index (BMI) >40 kg/m2
- Untreated depression. Subjects with depression who have been on stable anti-depressant medication, or undergoing CBT for more than three months are eligible.
- Men with axis I psychiatric disorder, such as schizophrenia, will be excluded.
- Subjects who have used the following medications within the past 6 months: testosterone, DHEA, estrogens, GnRH analogs, antiandrogens, spironolactone, ketoconazole, rhGH, megestrol acetate, prednisone 20 mg daily or equivalent doses of other glucocorticoids for more than two weeks
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
The purpose of this phase II trial is to determine the efficacy and safety of testosterone replacement therapy (TRT) in improving the symptoms of androgen deficiency and health-related quality of life in men with prostate cancer who have undergone radical prostatectomy.
Read the detailed description
The overall objective is to conduct a proof-of-concept double-blind, placebo-controlled, parallel group, randomized trial to determine the efficacy and safety of testosterone replacement therapy (TRT) in improving the symptoms of androgen deficiency (sexual symptoms, low energy, and physical dysfunction) and overall health-related quality of life in men with prostate cancer who have undergone radical prostatectomy for organ-localized disease (pT2,N0,M0), Gleason score < 7 (3+4), who have undetectable PSA (<0.1 ng/mL using a sensitive PSA assay) for > 2 years after radical prostatectomy, and who have androgen deficiency.
- Conditions
- Prostate Cancer
- Being tested
- Testosterone Cypionate 100 MG/ML, Placebo
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone Cypionate 100 MG/MLDrug
Also called Depo-Testosterone
100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.
PlaceboDrug
Also called Inactive comparator
Placebo administered by intramuscular injection weekly for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Active comparator | Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Receives: Drug: Testosterone Cypionate 100 MG/ML |
| Control Arm | Placebo comparator | Weekly IM administration of placebo for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Biochemical Recurrence of Prostate Cancer
The primary safety endpoint is the number of participants with biochemical recurrence of prostate cancer. Biochemical recurrence is defined as two or more consecutive serum PSA levels of 0.2 ng/mL or higher.
Measured: the 12-week treatment and the 3-month follow-up
Change From Baseline in Overall Sexual Activity, Assessed Using Psychosexual Diary Questionnaire (PDQ) Question 4
The primary efficacy endpoint is the change from baseline in overall sexual activity, assessed using Psychosexual Diary Questionnaire (PDQ) Question 4. Subjects complete the PDQ questionnaire daily for 7 consecutive days before each visit. The PDQ covers 3 domains:1) sexual desire, enjoyment, and performance; 2) sexual activity score; and 3) mood. Sexual activity (PDQ-4) is assessed using a checklist of 12 sexual activities including sexual interactions, masturbation, intercourse, erection, orgasm, and ejaculation on each of the 7 days. The value is recorded as 0 (none) or 1 (any) for each of the sexual activities. Weekly value is the sum of "any" responses for the week. The sexual activity score is the average of the weekly values. The score ranges from 0 to 12, with 0 indicating no activity had taken place that week and with higher values indicating more sexual activity.
Measured: Week 6, Week 12
Secondary outcomes (18)
Change in PSA
The secondary safety endpoint is change in PSA levels. Change from baseline in PSA could not be computed because the majority of the participants had undetectable PSA levels at baseline and post-baseline. Here, the number of participants with various PSA levels is reported.
Measured: Week 12
Change From Baseline in Lower Urinary Tract Symptoms, Ascertained Using the International Prostate Symptom Score (IPSS)
The secondary safety endpoint is the change from baseline in lower urinary tract symptoms, ascertained using the International Prostate Symptom Score (IPSS). The IPSS is a validated 8-question survey (7 symptom questions, 1 quality-of-life question) used to assess the severity of lower urinary tract symptoms (LUTS) associated with BPH, ranging from 0-35, with a higher score indicating a more severe negative symptoms.
Measured: Week 6, Week 12
Change From Baseline in Hemoglobin
The secondary safety endpoint is the change from baseline in hemoglobin levels.
Measured: Week 6, Week 12
Change From Baseline in Hematocrit
The secondary safety endpoint is the change from baseline in hematocrit levels.
Measured: Week 6, Week 12
Number of Participants With Erythrocytosis in the Two Study Arms
The secondary safety endpoint is the number of participants with erythrocytosis (confirmed hemoglobin > 18.0 g/dL) in the two study arms.
Measured: Week 12
Number of Participants With Clinical Prostate Cancer Recurrence in the Two Study Arms
The secondary safety endpoint is the number of participants with clinical prostate cancer recurrence in the two study arms.
Measured: Week 12
Change From Baseline in Sexual Desire, Assessed by the DeRogatis Inventory of Sexual Function Sexual Desire (DISF-SD) Questionnaire
The secondary efficacy endpoint is sexual desire, assessed by the DeRogatis Inventory of Sexual Function Sexual Desire (DISF-SD) Questionnaire. The DISF evaluates an individual's sexual health across five primary domains: sexual cognition/fantasy, arousal, behavior/experience, orgasm, and sexual drive/relationship. The Sexual Desire (SD) subset assesses an individual's subjective libido and frequency of sexual drive. The Sexual Desire score can range from 0 to 33, with a higher score indicating more sexual desire.
Measured: Week 6, Week 12
Change in Erectile Function Assessed by the International Index of Erectile Function (IIEF) Questionnaire.
The secondary efficacy endpoint is erectile function will be assessed by the International Index of Erectile Function (IIEF) Questionnaire. The IIEF is a 15-item questionnaire that covers 4 domains of sexual function: erectile function, sexual desire, orgasmic function, and intercourse satisfaction. Each question has a potential score of 0 to 5 for a maximal score of 75 for the entire scale. Our focus in this study is on erectile function domain score, which can range from 0 to 30, lower scores indicating poor erectile function, and higher score indicating better erectile function.
Measured: Week 6, Week 12
Change in Energy Level, Assessed Using the Hypogonadism Energy Diary (HED)
The secondary efficacy endpoint is energy level, assessed using the Hypogonadism Energy Diary (HED). The total HED scale score is the sum of each of the six item weekly scores, with higher scores corresponding to greater energy level. The HED total score is linearly transformed to a scale of 0-100. Lower scores indicate lower energy (or more tiredness) and higher scores indicate more energy (less tiredness).
Measured: Week 6, Week 12
Change in Mood, Assessed by the Positive and Negative Affect Schedule (PANAS)
Mood and well-being will be assessed by the Positive and Negative Affect Schedule (PANAS). The PANAS is a 20-item self-report measure to assess positive affect (PA) and negative affect (NA), with scores ranging from 10 to 50 for both the PA score and the NA score. For the PA score (10-50), higher scores represent higher levels of positive emotions, engagement, and enthusiasm. For the NA score (10-50), higher scores indicate higher levels of negative engagement, distress, and anxiety.
Measured: Week 6, Week 12
Change From Baseline in Prostate Cancer-related Quality of Life, Measured Using the Hormonal and Sexual Domains of the Expanded Prostate Cancer Index Composite (EPIC)
The secondary efficacy endpoint is change from baseline in prostate cancer-related quality of life measured using the hormonal and sexual domains of the Expanded Prostate Cancer Index Composite (EPIC). Expanded Prostate Cancer Index Composite Instrument (EPIC-26) for Measuring Health-Related Quality of Life Among Prostate Cancer Survivors EPIC QOL is a 26-item questionnaire that assesses quality of life in 5 domains: urinary incontinence, urinary irritation/obstruction, bowel, sexual and vitality/hormonal domain scores. All domains for EPIC-26 are reported on a 0 to 100 score, with higher scores representing favorable Health-Related Quality of Life (HRQOL).
Measured: Week 6, Week 12
Change From Baseline in Self-reported Physical Function, Assessed Using the Physical Function Component of MOS SF-36 (PF10)
The secondary efficacy endpoint is change from baseline self-reported physical function, assessed using the physical function component of MOS SF-36 (PF10). The PF-10 (Physical Functioning Scale) is the 10-item subscale within the MOS SF-36 assessing the extent to which health limits physical activities, such as self-care, walking, and lifting. Scores range from 0 to 100, where higher numbers mean better physical function and fewer limitations.
Measured: Week 6, Week 12
Change From Baseline in Performance-based Physical Function, Assessed by Measuring Loaded Stair Climbing Power
The secondary efficacy endpoint is change from baseline in performance-based physical function, assessed by measuring loaded stair climbing power.
Measured: Week 12
Change From Baseline in Chest Press Strength
The secondary efficacy endpoint is the change from baseline in Chest Press Max weight
Measured: Week 12
Change From Baseline in Leg Press Strength
The secondary efficacy endpoint is the change from baseline in Leg Press Max weight
Measured: Week 12
Change in Aerobic Capacity (VO2peak) Achieved During Cardiopulmonary Exercise Testing
The secondary efficacy endpoint is aerobic capacity (VO2peak) achieved during cardiopulmonary exercise testing.
Measured: Week 12
Change in Lean Body Mass
Change from baseline in whole body, appendicular, and trunk lean tissue mass measured using dual energy X-ray absorptiometry (DXA).
Measured: Week 12
Change in Fat Body Mass
Change from baseline in whole body, appendicular, and trunk fat tissue mass measured using dual energy X-ray absorptiometry (DXA).
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start19 Mar 2019
- Primary completion16 May 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Shalender Bhasin, MD, Dana-Farber Cancer Institute
- Investigators
- Shalender Bhasin, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716739
- Sponsor's protocol ID
- 18-733
- Other IDs
- 5R01AG060539-05
- Status last verified
- Jan 2025
- First submitted
- 2 Oct 2018
- Last updated
- 16 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Bhasin S, Burnett AL, Gagliano-Juca T, Storer TW, Reid KF, Shang YV, Privat F, Chandra MS, Weiss M, Memish-Beleva Y, Lam H, Kibel AS, Pencina KM. Testosterone Treatment in Prostate Cancer Survivors With Hypogonadism: A Randomized Clinical Trial. JAMA Intern Med. 2026 Jul 1;186(7):805-814. doi: 10.1001/jamainternmed.2026.1343.
PubMed 42113507Sentana-Lledo D, Saraf A, Morgans AK. Symptom Burden and Survivorship Care for Patients With Prostate Cancer on Androgen Deprivation Therapy. J Natl Compr Canc Netw. 2024 Dec 20;23(1):e247047. doi: 10.6004/jnccn.2024.7047.
PubMed 39705803
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency
- ClinicalTrials.gov ID
- NCT03716739
- Acronym / sponsor ID
- 18-733
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Posted 16 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this phase II trial is to determine the efficacy and safety of testosterone replacement therapy (TRT) in improving the symptoms of androgen deficiency and health-related quality of life in men with prostate cancer who have undergone radical prostatectomy.
Detailed description
The overall objective is to conduct a proof-of-concept double-blind, placebo-controlled, parallel group, randomized trial to determine the efficacy and safety of testosterone replacement therapy (TRT) in improving the symptoms of androgen deficiency (sexual symptoms, low energy, and physical dysfunction) and overall health-related quality of life in men with prostate cancer who have undergone radical prostatectomy for organ-localized disease (pT2,N0,M0), Gleason score < 7 (3+4), who have undetectable PSA (<0.1 ng/mL using a sensitive PSA assay) for > 2 years after radical prostatectomy, and who have androgen deficiency.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Active comparator | Drug: Testosterone Cypionate 100 MG/MLWeekly IM administration of 100 mg testosterone cypionate for 12 weeks. |
| Control Arm | Placebo comparator | Drug: PlaceboWeekly IM administration of placebo for 12 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men with prostate cancer, who have Stage pT2, N0, M0 lesions (confined to the gland); Combined Gleason score of 7 (3+4 elements) or less; Preoperative PSA less than 10 ng/ml; Stable and undetectable PSA level (PSA less than 0.1 ng/mL using an assay that has a functional sensitivity of 0.1 ng/mL) for at least two years after radical prostatectomy.
- Age: 40 years and older
- Presence of symptoms related to sexual dysfunction, fatigue/low vitality, or physical dysfunction.
- An average of two fasting, early morning serum testosterone levels, measured by LC-MS/MS, less than 275 mg/dL and/or free testosterone by equilibrium dialysis <60 pg/mL. middle-aged and older men with mean testosterone levels > 300 ng/dL.
- Ability and willingness to provide informed consent
Key exclusion criteria (13 listed)
- Men who have undergone radiation therapy
- Men receiving androgen deprivation therapy will be excluded.
- Hemoglobin <10 g/dL or >16.5 g/dL
- Severe untreated sleep apnea
- Allergy to sesame oil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone Cypionate 100 MG/MLAlso: Depo-Testosterone100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks. | Drug | Treatment Arm |
| PlaceboAlso: Inactive comparatorPlacebo administered by intramuscular injection weekly for 12 weeks. | Drug | Control Arm |
Primary outcome
Number of Participants With Biochemical Recurrence of Prostate Cancer
Time frame: the 12-week treatment and the 3-month follow-up
The primary safety endpoint is the number of participants with biochemical recurrence of prostate cancer. Biochemical recurrence is defined as two or more consecutive serum PSA levels of 0.2 ng/mL or higher.
Change From Baseline in Overall Sexual Activity, Assessed Using Psychosexual Diary Questionnaire (PDQ) Question 4
Time frame: Week 6, Week 12
The primary efficacy endpoint is the change from baseline in overall sexual activity, assessed using Psychosexual Diary Questionnaire (PDQ) Question 4. Subjects complete the PDQ questionnaire daily for 7 consecutive days before each visit. The PDQ covers 3 domains:1) sexual desire, enjoyment, and performance; 2) sexual activity score; and 3) mood. Sexual activity (PDQ-4) is assessed using a checklist of 12 sexual activities including sexual interactions, masturbation, intercourse, erection, orgasm, and ejaculation on each of the 7 days. The value is recorded as 0 (none) or 1 (any) for each of the sexual activities. Weekly value is the sum of "any" responses for the week. The sexual activity score is the average of the weekly values. The score ranges from 0 to 12, with 0 indicating no activity had taken place that week and with higher values indicating more sexual activity.
18 secondary outcomes
Change in PSA
Time frame: Week 12
Change From Baseline in Lower Urinary Tract Symptoms, Ascertained Using the International Prostate Symptom Score (IPSS)
Time frame: Week 6, Week 12
Change From Baseline in Hemoglobin
Time frame: Week 6, Week 12
Change From Baseline in Hematocrit
Time frame: Week 6, Week 12
Number of Participants With Erythrocytosis in the Two Study Arms
Time frame: Week 12
Number of Participants With Clinical Prostate Cancer Recurrence in the Two Study Arms
Time frame: Week 12
Change From Baseline in Sexual Desire, Assessed by the DeRogatis Inventory of Sexual Function Sexual Desire (DISF-SD) Questionnaire
Time frame: Week 6, Week 12
Change in Erectile Function Assessed by the International Index of Erectile Function (IIEF) Questionnaire.
Time frame: Week 6, Week 12
Change in Energy Level, Assessed Using the Hypogonadism Energy Diary (HED)
Time frame: Week 6, Week 12
Change in Mood, Assessed by the Positive and Negative Affect Schedule (PANAS)
Time frame: Week 6, Week 12
Change From Baseline in Prostate Cancer-related Quality of Life, Measured Using the Hormonal and Sexual Domains of the Expanded Prostate Cancer Index Composite (EPIC)
Time frame: Week 6, Week 12
Change From Baseline in Self-reported Physical Function, Assessed Using the Physical Function Component of MOS SF-36 (PF10)
Time frame: Week 6, Week 12
Change From Baseline in Performance-based Physical Function, Assessed by Measuring Loaded Stair Climbing Power
Time frame: Week 12
Change From Baseline in Chest Press Strength
Time frame: Week 12
Change From Baseline in Leg Press Strength
Time frame: Week 12
Change in Aerobic Capacity (VO2peak) Achieved During Cardiopulmonary Exercise Testing
Time frame: Week 12
Change in Lean Body Mass
Time frame: Week 12
Change in Fat Body Mass
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42113507Bhasin S, Burnett AL, Gagliano-Juca T, Storer TW, Reid KF, Shang YV, Privat F, Chandra MS, Weiss M, Memish-Beleva Y, Lam H, Kibel AS, Pencina KM. Testosterone Treatment in Prostate Cancer Survivors With Hypogonadism: A Randomized Clinical Trial. JAMA Intern Med. 2026 Jul 1;186(7):805-814. doi: 10.1001/jamainternmed.2026.1343.
- Derived from this study: PubMed 39705803Sentana-Lledo D, Saraf A, Morgans AK. Symptom Burden and Survivorship Care for Patients With Prostate Cancer on Androgen Deprivation Therapy. J Natl Compr Canc Netw. 2024 Dec 20;23(1):e247047. doi: 10.6004/jnccn.2024.7047.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shalender Bhasin, MD principal investigator
Brigham and Women's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Testosterone Cypionate 100 MG/ML in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Biochemical Recurrence of Prostate Cancer (time frame: the 12-week treatment and the 3-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03716739, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.