by Jan Manarite, 3/1/25
Years ago, many Phase 3 trials in prostate cancer had a placebo group.
Not any more…
New treatments are now almost always compared to a current “standard” treatment. It’s extremely rare for a prostate cancer clinical trial to have a placebo (sugar pill) group.
The only way you know – is to ASK. Throughout my 13 year journey with my husband’s metastatic PC, I learned that Better Questions get you Better Answers!
Most prostate cancer phase 3 trials compare a new treatment regimen to something considered ‘standard of care’ Here are 2 examples:
- The PSMAfore trial is testing Pluvicto (Lu-177) before chemotherapy compared Pluvicto to an ‘androgen receptor-directed therapy’ (Zytiga or Xtandi), which would be considered “standard of care” for the mCRPC patients eligible for the trial.
- Several years ago, in the ARASENS trial, darolutamide (Nubeqa) was added to “standard ADT (androgen deprivation therapy)” plus chemotherapy in one group, while the other group received the standard ADT plus chemotherapy without the Nubeqa. No patients received placebo alone – all were on treatment.
Phase 2 Clinical Trials Seldom have Placebo. ASK.
Phase 2 trials are conducted after a treatment passes safety and effectiveness evaluation in a smaller Phase 1 trial. Most Phase 2 Clinical Trials also DON’T have placebo.
(REF – https://www.pcf.org/patient-resources/patient-navigation/prostate-cancer-clinical-trials/ )
So make sure you ask your physician and nurse if there is a placebo alone group in the clinical trial you are considering. The answer is likely ‘no’.
Remember: A clinical trial may give your cancer the chance to be treated with something that ISN’T available on the market yet. Clinical trial treatments are typically FREE. Ask.
*This article has been approved for accuracy by our Medical Advisory Board.
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