None listed
Conditions
Brief summary
This study is looking at the efficacy of testosterone cream as a treatment option for men who continue to have low testosterone after prostate cancer treatment. Who is it for? You may be eligible for this study if you are an adult male with clinically localised low-intermediate risk prostate cancer treated with radiotherapy and at least 6 months of androgen deprivation therapy (ADT) with curative intent and have experienced prolonged androgen deficiency more than 6 months after cessation of ADT. Study details Participants will be randomly allocated to either use testosterone cream or a placebo cream daily for 6 weeks. They will undergo blood tests at baseline, 3 and 6 weeks to assess testosterone and other hormone levels, as well as complete questionnaires on quality of life and psychosocial domains. It is hoped that findings from this study will help researchers develop new ways of treating low testosterone levels and associated symptoms in men following prostate cancer treatment.
Interventions
0.5 mL (25 mg testosterone) of testosterone 5% w/v cream applied daily to scrotal skin for 6 weeks. Participants will be questioned regarding adherence to treatment, and asked to return drug product at the end of the study to verify adherence.
Sponsors
Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult men (greater than or equal to 18 years) with clinically localised low-intermediate risk prostate cancer treated with radiotherapy and at least 6 months of ADT with curative intent who have experienced prolonged androgen deficiency more than 6 months after cessation of ADT. Further inclusion criteria: Localised, low or intermediate risk prostate cancer at diagnosis, defined according to American Urological Association (AUA)/American Society for Therapeutic Radiology and Oncology (ASTRO) guidelines: o Low risk - prostate specific antigen (PSA) <10 ng/mL AND Grade Group 1 AND clinical stage T1-T2a o Intermediate-Risk - PSA 10-<20 ng/mL OR Grade Group 2-3 OR clinical stage T2b-c - Favourable: Grade Group 1 with PSA 10-<20 ng/mL or clinical stage T2b-c and <50% biopsy cores positive OR Grade Group 2 with PSA<10 ng/mL and clinical stage T1-2a and <50% biopsy cores positive - Unfavourable: Grade Group 1 with PSA 10-<20 ng/mL and clinical stage T2b-c OR Grade Group 2 with PSA 10-<20 ng/mL and/or clinical stage T2b-c and/or greater than or equal to 50% biopsy cores positive OR Grade Group 3 with PSA <20 ng/mL • Treated with radiotherapy (brachytherapy, external beam radiotherapy or stereotactic body radiotherapy) with curative intent • Received at least 6 months of Androgen Deprivation Therapy (ADT) using a depot GnRH agonist • Study entry (screening visit) at least 6 months after the end of depot GnRH agonist treatment (i.e. 6 months after the first missed depot treatment) • Serum testosterone concentration <6 nmol/L (regardless of symptoms) OR Serum testosterone concentration 6-10.4 nmol/L with symptoms of androgen deficiency
Exclusion criteria
• High risk clinically localised prostate cancer • Advanced prostate cancer, including all non-localised, nodal and metastatic disease • Gleason score greater than or equal to 8 • Clinical recurrence following definitive radiotherapy • Biochemical failure after definitive radiotherapy, defined as a PSA rise of 2 ng/mL or more above nadir PSA, including if identified at screening visit • Current androgen or anti-androgen therapy use • Major chronic medical illness or organ failure • Life expectancy less than 12 months • Contraindication to testosterone therapy as assessed by the patient’s Radiation Oncologist or Urologist.
Outcome results
None listed