Clinical Trials Details

Public Title   

TOAD - Timing of androgen deprivation intervention in prostate cancer patients with a rising PSA | TOAD

Contacts   

Deborah Howell
The Cancer Council Victoria
1 Rathdowne Street
Carlton VIC 3053
+61(0)3 9635 5179 (phone)
+61(0)3 9635 5410 (fax)
Deborah.Howell@cancervic.org.au
Australia

Recruitment Status   

Recruiting

Focus of Trial   

Treatment

Phase of Trial   

Phase 3

Recruitment Dates   

Anticipated start date
01/08/2004

Anticipated end date
NA

Trial Summary   

This is a clinical trial for patients with prostate cancer. The aim of the project is to provide information about the best timing to start treatment in men who have a rising PSA (prostate specific antigen) blood test, after having had treatment with the aim of curing their prostate cancer. In some men, the surgery or radiotherapy given initially in the attempt to cure the cancer is not successful. One of the earliest ways of detecting recurrence of the cancer in these men is with the PSA blood test, which can detect activity of the cancer months or years before other tests, and usually long before any symptoms appear.
We know that treatment with hormone therapy – removing the male hormone testosterone – is helpful in controlling advanced disease causing symptoms, although it is not a cure. This is called ‘androgen deprivation’, testosterone being an androgen hormone. The cancer cells are deprived of a source of energy, keeping them under control for a while, but eventually they tend to start growing again in spite of the treatment. We know that using androgen deprivation usually causes the PSA level in men to fall, including men in your situation who have no other signs of active cancer. What we do not know is whether using androgen deprivation immediately the PSA starts to rise will prolong life more than waiting to start treatment until there are other signs that the disease is progressing.
It would be simple to start everyone on treatment with androgen deprivation if there were no side effects with the treatment. However, there are a number of side effects that may interfere with day-to-day living. These include (but are not limited to): hot flushes, tiredness, anaemia, and loss of muscle mass and bone density. There may be weight gain, and nipple tenderness or swelling. Some men notice changes in mental function, or shortness of breath. Most also find that sex drive and erectile function, if normal before starting treatment, cease. Quality of life may be affected. If androgen deprivation therapy is ceased, some of the side effects (such as loss of sex drive, loss of muscle bulk or bone mineral density) may be halted or reversed. Generally the standard approach would be to delay introducing treatment until the disease progresses.
So the purpose of the study is to see whether immediate treatment is better or worse than delayed treatment in terms of prolonging lifespan, balanced against the effects on the quality of life.

Description of the Study   


Description of the Control
Patients will be randomised to receive androgen deprivation therapy delayed for at least 2 years or until evidence of significant disease progression (control arm).

Description of the Intervention
Patients will be randomised to receive androgen deprivation therapy either immediately (experimental arm)

Allocation to Intervention
Randomised controlled trial

Target Sample Size   

750

Primary Outcomes   

The primary endpoint of the trial is death from any cause
Measured at 6 monthly assessments

Secondary Outcomes   

Cancer specific survival
6 monthly for 5 years

Clinical progression
6 monthly for 5 years

Time to first androgen independence
6 monthly for 5 years

Complication rate incidence and timing (eg cord compression, pathological fracture)
6 monthly for 5 years

Treatment related morbidity (including cognitive, osteoporosis)
6 monthly for 5 years

Quality of life
6 monthly for 5 years

Prognostic factors for progression (delayed group)
6 monthly for 5 years

Inclusion Criteria   

STUDIES 1 AND 2- Histologically confirmed adenocarcinoma of the prostate- Accessible for follow-up- Informed consent to be randomised to immediate or delayed androgen deprivation- Males aged 18 years and overINCLUSION CRITERIA STUDY 1 PSA relapse after definitive radical treatment- No evidence of metastatic disease on staging investigations (bone scan, abdomino-pelvic CT scan)- Prior androgen deprivation limited to a maximum of seven months neo-adjuvant/concurrent treatment, completed at least 12 months prior to study entryINCLUSION CRITERIA STUDY 2- Not suitable for radical treatment at primary diagnosis.- Decision not to treat curatively- No symptoms due to local or metastatic disease requiring radiation or immediate hormone therapy- No prior androgen deprivation therapy

Minimum Age:
18 Years

Maximum Age:
Not stated

Gender:
Males

Ethics Approval   

Yes

Trial Sponsors   

Primary Sponsor:
Charities/Societies/Foundations
The Cancer Council Victoria
1 Rathdowne St, Carlton South, 3053, VIC
Australia

Secondary Sponsor:
Other Collaborative groups
Trans Tasman Radiation Oncology Group (TROG)
Dept of Radiation Oncology
Newcastle Mater Misericordiae Hospital
Locked Bag7, NHMRC NSW 2310
Australia

Funding Source   

Government body
National Health & Medical Research Council
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Australia
Commercial sector/Industry
untied pharmaceutical company grants
Hospira
Level 6, 390 St Kilda Road
Melbourne, VIC, 3004
Australia