Localised diseaseACTIVE - Not recruiting Prostate Cancer Trials
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1. TROG 03.06 - TOAD
A collaborative randomised phase III trial: The timing of intervention with androgen deprivation in prostate cancer patients with a rising PSA
Sponsor: Trans Tasman Radiation Oncology Group [TROG] Phase 3
TOAD study aims to determine if early intervention with androgen deprivation therapy in prostate cancer patients suffering a PSA relapse (Study 1), or considered unsuitable for curative treatment (Study 2), improves overall survival while maintaining an acceptable quality of life, when compared to delayed intervention.
Study drugs: Leuprorelin acetate or Goserelin acetate
Participating Radiation Oncology Network Sites: Nepean Cancer Care Centre Westmead Cancer Care Centre
Eligibility criteria: Current Protocol / Schema / Patient work-up packages are available -> WCCC clinic 4 NCCC RADONC Clinical Trial Team Go to SCHEMA Go to www.trog.com.au
Status: Recruiting.
Contact: Radiation Onoclogy Network - Clinical Trial Team Nepean Cancer Care Centre ph 4734 3523 Westmead Cancer Care Centre ph 9845 5575 / 9845 5254
2. TROG 08.01 - PROFIT
A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer
Sponsor: Trans Tasman Radiation Oncology Group [TROG] Phase 3
This trial is designed to determine whether an 8-week course of escalated dose conformal radiation can be compressed safely, and with similar efficacy into a 4-week course.
Eligibility criteria: Current Protocol / Schema / Patient work-up packages will be available -> WCCC clinic 4
Go to SCHEMA Go to www.trog.com.au Go to the Clinical Trials.gov.link
Participating Radiation Oncology Network Sites: Westmead Cancer Care Centre
Status: Not yet recruiting.
Contact: Radiation Onoclogy Network - Clinical Trial Team Westmead Cancer Care Centre ph 9845 5575 / 9845 5254
3. TROG 08.03 RAVES
Radiotherapy - Adjuvant Versus Early Salvage. A Phase III Multi-Centre Randomised Trial Comparing Adjuvant Radiotherapy (RT) With Early Salvage RT in Patients With Positive Margins or Extraprostatic Disease Following Radical Prostatectomy.
Sponsor: Trans Tasman Radiation Oncology Group [TROG] Phase 3
Radical prostatectomy (RP) is the most common curative approach offered to men with newly diagnosed prostate cancer. Unfortunately, up to half of these patients will have factors placing them at high risk of their cancer recurring. Having radiotherapy after RP is known to improve cure rates, but what is not known is whether it should be given straight after the operation or only when there is a rising PSA after surgery indicating active cancer. Immediate RT may not benefit all men, and can cause serious side effects such as bladder and bowel problems and impotence. International lack of consensus on the optimal timing of RT has resulted in varied clinical practice. This phase 3 trial will compare the two approaches.
Eligibility criteria: Current Protocol / Schema / Patient work-up packages will be available -> WCCC clinic 4
Go to SCHEMA Go to www.trog.com.au Go to the ClinicalTrials.gov link
Participating Radiation Oncology Network Sites: Westmead Cancer Care Centre
Status: Not yet recruiting.
Contact: Radiation Onoclogy Network - Clinical Trial Team Westmead Cancer Care Centre ph 9845 5575 / 9845 5254
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Advanced/metastatic Castrate refractory1. FIRST LINE CHEMOTHERAPY -No trial open2. BEFORE CHEMOTHERAPY, with metastases - PREVAIL TRIAL Sponsor: Medivation Phase 3
Metastatic disease with rising PSA but not yet requiring chemotherapy.
Study drug: MDV3100. On oral antiandrogen drug that has better affinity for the androgen receptor than bicalutamide and less likely to translocate to the nucleus thus reducing the chance of an agonistic effect.
Eligibility Criteria: Go to the ClinicalTrial.gov page
Status: Recruiting Basic screening tests: Imaging - Bone scan; CT scan C,A+P; ECG; Bloods - PSA (3 rising), testosterone, FBC, biochem Contact: Raymond Tangunan ph 9845 9564 Page 09571 4. AFTER DOCETAXEL and/or MITOZANTRONE - TAK 700 TRIALSponsor: Millennium Pharmaceuticals
Study Drug: Orteronel is a oral CYP17 inhibitor which inhibits production of adndrogens in testis, adrenal and in prostate cancer.
Eligibility Criteria: Go to the ClinicalTrial.gov page
Prevention of metabolic syndrome induced by LHRH agonists1. JUST BEFORE STARTING HORMONE THERAPY - MVENTMetformin in preventing Androgen Deprivation Therapy-induced Insulin Resistance and Metabolic Syndrome Sponsor: Westmead Medical Oncology Phase 2 Any patient due to commence LHRH agonist for 6 months or more. Study drug: LHRHagnoists (eg zoldex, lucrin) are associated with metabolic syndrome with an increased risk of diabetes and cardiac death. This is thought to be mediated through the development of insulin resistance. In this study, metformin will be used to test whether the metabolic syndrome can be abrogated. Metformin inhibits AMP-activated protein kinase (AMPK). This indirectly inhibits the m-TOR pathway and reduces gluconeogenesis. Increasingly, metformin has been found to have anti-cancer effects, probably by this inhibition of mTOR. Eligibility: Go to Protocol Status: Recruiting Contact: Bo Gao |