Clinical trial · Interventional
Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer
A Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients With Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer
- 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 stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. It is not yet known which androgen suppression regimen is more effective for prostate cancer. PURPOSE: This randomized phase III trial is studying two hormone therapy regimens and comparing them to see how well they work in treating patients with rising PSA levels following radiation therapy for 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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bicalutamide | Drug | Bicalutamide | ALIAS |
| buserelin | Drug | Buserelin | ALIAS |
| cyproterone acetate | Drug | Cyproterone Acetate | ALIAS |
| flutamide | Drug | Flutamide | ALIAS |
| goserelin | Drug | Goserelin | ALIAS |
| leuprolide acetate | Drug | Leuprolide | ALIAS |
| nilutamide | Drug | Nilutamide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intermittent Androgen Suppression
- interventionNames
- Drug: bicalutamide
- Drug: buserelin
- Drug: cyproterone acetate
- Drug: flutamide
- Drug: goserelin
- Drug: leuprolide acetate
- Drug: nilutamide
- type
- ACTIVE_COMPARATOR
- label
- Continuous Androgen Suppression
- interventionNames
- Drug: bicalutamide
- Drug: buserelin
- Drug: cyproterone acetate
- Drug: flutamide
- Drug: goserelin
- Drug: leuprolide acetate
- Drug: nilutamide
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 16 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically proven adenocarcinoma of the prostate prior to the initiation of radiotherapy * Prior pelvic radiotherapy for prostate cancer, either post-radical prostatectomy or as primary management * More than 30 months since prior brachytherapy with curative intent * Prostate-specific antigen must be rising and greater than 3 ng/mL and higher than the lowest level recorded previously since the end of radiotherapy (i.e., higher than the post-radiotherapy nadir) * Total testosterone greater than 5 nmol/L * No definite evidence of metastatic disease * Chest x-ray and bone scan negative for metastases * Radiological changes compatible with nonmalignant diseases allowed * Clinical evidence of local disease allowed PATIENT CHARACTERISTICS: Age: * 16 and over (18 and over for participating centers in the United Kingdom) Performance status: * ECOG 0-1 Life expectancy: * More than 5 years Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST/ALT no greater than 1.5 times ULN * LDH no greater than 1.5 times ULN * No chronic liver disease Renal: * Creatinine no greater than 1.5 times ULN Other: * Sufficiently fluent and willing to complete the quality of life questionnaire in either English or French * Fertile patients must use effective contraception * No other malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer or superficial bladder cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior or concurrent biologic therapy Chemotherapy: * No prior or concurrent chemotherapy Endocrine therapy: * Prior hormonal therapy administered prior to, during, or immediately after radical radiotherapy or prostatectomy allowed provided duration was no longer than 12 months * At least 12 months since prior hormonal therapy Radiotherapy: * See Disease Characteristics * At least 12 months since prior radiotherapy * No concurrent palliative radiotherapy Surgery: * See Disease Characteristics * See Endocrine therapy Other: * No concurrent bisphosphonates
References
Publications (4)
- BACKGROUNDKlotz L, Correia A, Zhang W. The relationship between the androgen receptor CAG repeat polymorphism length and the response to intermittent androgen suppression therapy for advanced prostate cancer. Prostate Cancer Prostatic Dis. 2005;8(2):179-83. doi: 10.1038/sj.pcan.4500792. PMID 15809670
- RESULTCrook JM, O'Callaghan CJ, Duncan G, Dearnaley DP, Higano CS, Horwitz EM, Frymire E, Malone S, Chin J, Nabid A, Warde P, Corbett T, Angyalfi S, Goldenberg SL, Gospodarowicz MK, Saad F, Logue JP, Hall E, Schellhammer PF, Ding K, Klotz L. Intermittent androgen suppression for rising PSA level after radiotherapy. N Engl J Med. 2012 Sep 6;367(10):895-903. doi: 10.1056/NEJMoa1201546. PMID 22931259
- DERIVEDHamilton RJ, Ding K, Crook JM, O'Callaghan CJ, Higano CS, Dearnaley DP, Horwitz EM, Goldenberg SL, Gospodarowicz MK, Klotz L. The Association Between Statin Use and Outcomes in Patients Initiating Androgen Deprivation Therapy. Eur Urol. 2021 Apr;79(4):446-452. doi: 10.1016/j.eururo.2020.12.031. Epub 2020 Dec 31. PMID 33390282
- DERIVEDKlotz L, O'Callaghan C, Ding K, Toren P, Dearnaley D, Higano CS, Horwitz E, Malone S, Goldenberg L, Gospodarowicz M, Crook JM. Nadir testosterone within first year of androgen-deprivation therapy (ADT) predicts for time to castration-resistant progression: a secondary analysis of the PR-7 trial of intermittent versus continuous ADT. J Clin Oncol. 2015 Apr 1;33(10):1151-6. doi: 10.1200/JCO.2014.58.2973. Epub 2015 Mar 2. PMID 25732157