Clinical trial · Interventional
Androgen Deprivation Therapy in Treating Patients With Prostate Cancer
A Collaborative Randomized Phase III Trial: The Timing of Intervention With Androgen Deprivation in Prostate Cancer Patients With Rising PSA
NCT00110162CI-TRIAL-00011616unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. PURPOSE: This randomized phase III trial is studying how well androgen deprivation therapy works in treating patients with prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| antiandrogen therapy | Drug | — | UNRESOLVED |
| orchiectomy | Procedure | — | UNRESOLVED |
| releasing hormone agonist therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Death from any cause at 8 years
Secondary outcomes (9)
- measure
- Cancer specific survival
- measure
- Clinical progression
- measure
- Time to first androgen independence
- measure
- Complication rate incidence and timing (e.g., cord compression, pathological fracture)
- measure
- Treatment-related morbidity (including cognitive, osteoporosis)
- measure
- Prognostic factors for progression (delayed group)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Prostate-specific antigen (PSA) relapse OR incurable disease diagnosed within the past 2 months AND meets criteria for either of the following groups:
* Group 1
* In PSA relapse after definitive radical treatment (prostatectomy or radiotherapy), as evidenced by 1 the following:
* Post-prostatectomy PSA level ≥ 0.2 ng/mL
* At least 3 rising PSA levels (post-radiotherapy) obtained ≥ 1 month apart, with the last PSA obtained within the past 2 months
* No metastatic disease by bone scan or abdomino-pelvic CT scan
* Group 2
* Not suitable for radical treatment at primary diagnosis
* Not planning to receive curative treatment
* Localized or metastatic disease
* No symptomatic disease requiring radiotherapy or immediate hormonal therapy
* No symptomatic disease requiring therapy
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* Not specified
Life expectancy
* At least 5 years
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* No other significant comorbid condition that would limit life expectancy to \< 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* At least 12 months since prior androgen deprivation therapy (ADT) administered in the neoadjuvant or concurrent (with radiotherapy) setting (group 1)
* No prior ADT (group 2)
Radiotherapy
* See Disease Characteristics
* See Endocrine therapy
Surgery
* See Disease Characteristics
Other
* No concurrent enrollment in TROG-96.01 or TROG-RADAR protocolsReferences
Publications (2)
- DERIVEDDuchesne GM, Woo HH, King M, Bowe SJ, Stockler MR, Ames A, D'Este C, Frydenberg M, Loblaw A, Malone S, Millar J, Tai KH, Turner S. Health-related quality of life for immediate versus delayed androgen-deprivation therapy in patients with asymptomatic, non-curable prostate cancer (TROG 03.06 and VCOG PR 01-03 [TOAD]): a randomised, multicentre, non-blinded, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1192-1201. doi: 10.1016/S1470-2045(17)30426-6. Epub 2017 Jul 28. PMID 28760403
- DERIVEDDuchesne GM, Woo HH, Bassett JK, Bowe SJ, D'Este C, Frydenberg M, King M, Ledwich L, Loblaw A, Malone S, Millar J, Milne R, Smith RG, Spry N, Stockler M, Syme RA, Tai KH, Turner S. Timing of androgen-deprivation therapy in patients with prostate cancer with a rising PSA (TROG 03.06 and VCOG PR 01-03 [TOAD]): a randomised, multicentre, non-blinded, phase 3 trial. Lancet Oncol. 2016 Jun;17(6):727-737. doi: 10.1016/S1470-2045(16)00107-8. Epub 2016 May 4. PMID 27155740